Automated Sample Extractor or Feeder/Inoculator for Bioreactors and Similar Equipment

1. Field of the Invention

The present invention relates to an automated sample extractor or feeder/inoculator and a removable manual override operator for a vessel or conduit. This vessel or conduit can be a bioreactor or other similar equipment.

2. Description of the Background Art

Development of new or more efficient commercialization of existing products requires faster and more effective methods to measure process variables. This is particularly true in processes which require cell culture and fermentation processes conducted in bioreactors where the accuracy of measurements in the research and development are critical for achieving economic production of high purity and highly refined end products.

Some factors which must be controlled include temperature and pressure. These factors are easily measured by utilizing standard sensors. However, many other factors can be measured only by removing samples for external laboratory analysis. The frequency of sample extraction for testing and measurement, number of tests on each sample and the time constraints on the process vary widely as do the methods and equipment used to obtain the samples.

In most cases, measurement processes for variables do not lend themselves to in-situ measurement by remote sensors directly in the process. Instead, samples must be physically extracted from the process and examined and manipulated outside the vessel or conduit. Before this examination and manipulation process can be carried out, a safe, effective means of sample extraction must be made available. Besides being safe and effective, the means of sample removal should also take into consideration that the character of sample material taken from one place is very likely to differ from that taken from another place. Therefore, it is important to provide a means by which sample material can be removed from the vessel from a location where its character correlates well with information being derived from in-situ sensor measurements as well as with the character of the bulk of the process material.

The prior art provides for removal of sample material but does not provide features that could adequately address issues concerning the quality of the material as a representative sample of the process. Many of the prior art designs do not lend themselves easily to use as a retrofit but, instead, require substantial modification to the system for installation or repositioning. An apparatus should minimize or eliminate the dangers associated with the sampling process in an efficient and cost effective manner while providing quality, reproducible results in order to be of value for commercial application.

When working with samples, especially hazardous samples, it is necessary to remove or feed/inoculate a sample without endangering the integrity of the process, subsequent samples, the operator or the outside environment. Many prior art devices are unsatisfactory in this area.

Also, some prior art systems are not automated. Therefore, there is potential danger posed by human procedural errors which could easily result in operator and environmental exposure. Accordingly, a need exists for an automatable apparatus with the capacity for independent verification of equipment operation built in.

There is a need for an automated system which offers a quick, easy-to-use means to override the automation apparatus. Sampling is most important in processes of which relatively little is known. Consequently, there is always a need to collect unanticipated samples. In providing this means, it is critical that the apparatus should be able to provide essentially identical samples in either case (i.e. manual or automated mode). Furthermore, the materials being sampled themselves are often expensive. Therefore, excessive removal of sample should be avoided.

In the existing art, rotating cams and rotating knobs or handwheel are usually the means employed to open and close sampling valves. These designs require the operator to move their arm or, at least their hand, through a range of motion of 90-180 degrees or more. In the very best conditions this motion will take at least 1.0 second to perform a full cycle (open and close). Since most sample port apertures are 5 mm or more in diameter, it is very likely that 30 ml or more of process material will flow out between the time the valve is opened and closed. Usually the volume of sample required is small, often 50 ml or less.

As a consequence, one of two events occurs. Either a relatively large amount of sample material is wasted or the technician must resort to "throttling" the valve (partially opening it). Since process material is either valuable, hazardous or there is a need for cleanliness, there is a tendency of technicians to resort to throttling the valve to more carefully and accurately control the flow of sampling material. However, "throttling" can significantly alter the sample in two important ways.

First, the smaller, more fluid elements of the sample will more easily pass through the constricted opening rather than the larger, more viscous elements. The result is a selective removal, or sieving out, of the larger, more viscous elements from the sample.

Second, those elements that do pass through the crevice will have been subjected to high levels of shear, possibly significantly altering their physical and chemical properties, changing them from the desired representative subsample of process populations and conditions.

An effective means to minimize this effect will require the valve to be opened to a full open position until enough sample is drawn at which time the valve must be rapidly closed. Automated actuation using electromagnetic solenoids or pneumatic actuators which have only two position, "open" or "closed", are much more preferable over "throttling" or "positioning" actuators.

Likewise, to eliminate sample bias in a manually operated valve, a manual motion which can be rapidly translated into full articulation of the operating rod from fully "closed" to fully "opened" and back must be realized. The fastest (articulating) elements in humans, besides the eyes, are the fingers. A "flick" or "snap" of the fingers takes a fraction of a second. Since most sample particles are much smaller than the range of motion used in a single flick of a finger, direct coupling of finger motion to actuation of the operating rod of the sampling valve presents an effective solution. Furthermore, because of the relatively small crossectional area of sampling orifice and the relatively moderate pressures used in most (biological) processes, little or no gear reduction will be required to overcome the tension of a "fail close" return spring operating on valve operating rod to close form a seal at orifice. The mechanism described here can easily and quickly be removably connected to valves with automated mechanisms. When manual sampling is necessary, trigger-action control can provide a more physically and chemically representative subsample of the process with more precise control of sampling volumes with less wasting of material.

When taking samples, it is often important to maintain an aseptic environment. It is important that contamination from previous sampling or from the environment not contaminate the current sample or the process being sampled. Loss of a sample run or contamination of the process can have extremely expensive ramifications. Therefore, it is important to obtain a sample without the sampling procedure causing contamination.

Many prior art devices permit accumulation or pooling of samples or cleansing medium. When the device is first used this may not create a problem; however, upon subsequent runs, the samples will be contaminated or at least diluted.

Additionally in the prior art, technology used for taking samples is generally unsatisfactory for feeding/inoculating the vessel or container.

Accordingly, it is a primary object of the present invention to provide an apparatus for moving a sample of flowable material either in an automated or manual fashion into a vessel or conduit (an inoculation apparatus) or to move a sample of the flowable material from the vessel or conduit (a sample extractor).

It is an object of the present invention to provide an apparatus which can be retrofitted to existing standard tank port holes without requiring equipment modification.

It is the further object of the invention to provide means to retrofit the present invention into existing tanks port holes of different lengths or to be installed in a penetrating configuration, equivalent to other in-situ sensors.

Another object of the present invention is to provide an apparatus which will provide a representative subsample of the process composition.

It is a further object of this invention to provide an automated and manual means of sampling the process, the results of either being of equivalent quality and equally being representative of the process.

It is also an object of the invention to provide a means by which manual and automated operators can be added, removed or exchanged from the valve while it is in service and without jeopardizing the aseptic integrity of either the process or the outside environment.

Another object of the invention is to provide a device that has a safety catch so that the valve cannot accidentally be opened. Furthermore, it is the object of the invention to provide within the same means a way to lock the valve in the open position to facilitate the taking of large volume of samples.

A further object of the apparatus is to provide a means by which samples can be safely and reliably taken automatically without having to worry about injury to someone who could be caught unaware standing near or up against the device when it automatically actuates. A corollary to this is that blockage to the mechanical elements and interference with sample taking is also avoided.

Still another object of the present invention is to eliminate or minimize the dangers of the sampling process such as contamination of the sample, process or surrounding environment.

It is a further object of the present invention to provide an apparatus which will conduct a sampling and maintain the sample in sealed arrangement such that there will be no danger to the sample itself or to the operator, the process and the surrounding environment.

Another object of the present invention is to provide an automatable system to eliminate operator error.

It is the object of the invention to provide means for effectively duplicating automated action in a manual override mechanism.

Yet another object of the present invention is to provide for a built-in verification of proper operation of the apparatus.

Still another object of the present invention is to provide a sample apparatus which avoids contact of the sample with dynamic (sliding or rotating) seals, thereby avoiding potential sites for accumulation of carryover contaminants.

A further object of the present invention is to eliminate the usual static crevice areas which may collect contaminates but yet are inaccessible to cleaning and sterilization agents and thus eliminates areas which might harbor carryover contaminants.

It is a further object of the present invention to avoid dead (stagnant) spaces in the apparatus which would result in samples that are not truly reflective of the process.

Yet another object of the present invention is to avoid obstacles or barriers to free drainage of the samples.

Still another object of the present invention is to provide a flushing arrangement for the apparatus whereby contaminants and other material will be forced from the system.

Yet a further object of the present invention is to avoid excess process void volume inside the apparatus which would result in sample volume measurement difficulties and material wastage.

Still another object of the present invention is to avoid passive "breathing" between the seals of the apparatus and the outside environment.

Another object of the present invention is to provide an apparatus which can be repeatedly cleaned and/or sterilized in place.

A further object of the invention is to provide a means by which samples can be extracted from within the body of the process closer to where the sensors take their readings rather then at the margins where samples are taken as when using prior art devices.

It is an additional object of the invention to minimize the amount of heat exchanged between the apparatus and the process within the vessel or conduit, especially during heat sterilization cycles.

Yet another object of the present invention is to provide an apparatus which can easily be removed and quickly disassembled for maintenance, including replacement of worn parts.

A further object of the present invention is to provide an apparatus whose materials are compatible with the sample materials and the process.

Yet another object of the present invention is to provide a low cost apparatus which can effectively carry out sampling or inoculation.

Still another object of the present invention is to provide an apparatus which will be reliable, easy to maintain and low cost.

Another object of the present invention is to provide multiple use capability of the apparatus including feeding/inoculation as well as sampling.

These and other objects of the present invention are fulfilled by providing an apparatus for moving a sample of flowable material through a port in a wall of a vessel or conduit. Thus, this apparatus can either feed in or withdraw materials.

The apparatus comprises a body having an internal cavity with an end wall and an orifice in that end wall. The walls near the end wall and the endwall, itself, are hollow. The purpose of the hollow character being one of isolating the thermal internal valve sterilization process from the heat sensitive process material into which it protrudes. Means (a threaded collar or clamp, for example) which is adjustable in position along the body is provided for coupling the body to the port in the vessel or conduit. A diaphragm valve is positioned within the internal cavity of the body. This bulbous diaphragm valve has a rubber bellows with a tubular body and a blunt sealing tip. The tip can be moved to close or open the orifice. The tubular body of the valve is spaced from the interior surfaces of the internal cavity to thereby define a sample cavity. This sample cavity is communicable with the orifice. A valve operating rod is attached to the blunt sealing tip and is moved by an appropriate drive to open and close the orifice.

The valve operating rod extends out the rear of the valve through a plate attached to the rear wall of the valve. This plate includes seals that isolate the valve interior from the outside environment.

A manual valve actuator, including a leverage adjustable trigger mechanism, a safety catch, a secondary return spring with spring tension adjustment and a stroke-limiting backstop, may be removable connected to the valve body and operating rod at the back of the valve. An automated actuator can also be removable added at the same point with the trigger mechanism being removed and reattached onto the rear wall of the automated actuator. The valve operation, therefore, can be either manually or automatically driven, the manual method being one of a finger controlled trigger action mechanism while the automated method being one employing a pneumatic, electromagnetic or other acceptable means of actuation. The results in all cases are essentially the same back and forth articulation of the valve operating rod resulting in opening and closing of the valve.

A drain passage leads away from the sample cavity of the body while an inlet passage leads to the sample cavity of the body. This drain passage has a longitudinal axis which is offset with regard to the longitudinal axis of the body. Similarly, the inlet passage has a longitudinal axis which is not only offset from the longitudinal axis of the body but is also offset from the longitudinal axis of the drain passage.

In one arrangement, steam, air and/or a wash medium can be supplied through the inlet passage, sample cavity and out the drain passage in order to clean the interior of the apparatus. With the tip of the valve moved to open the orifice, the sample can then be extracted from the vessel or conduit through the sample cavity and out the drain passage. This sample will be fed to means for collecting the sample.

When the apparatus is used for feeding or inoculating, the drainage valve is closed. This diaphragm valve is retracted and the feed or inoculant is forced through the feed passage, past the diaphragm valve into the vessel or conduit.

If, when the adjustable collar is positioned part way forward along the barrel of the valve and the tip of the valve is flush with the inside wall of the vessel, the collar may be repositioned all the way back on the barrel of the valve and reinserted into the ferrule. Now the secondary o-ring in the valve cap forms the seal with the ferrule and the tip of the valve will protrude beyond the margins of the vessel into the body of the process in a fashion similar to that of in-situ sensors. Since this is the region where the sensors take their readings, taking samples from this area will correlate better with sensor readings.

Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein:

FIG. 1a is a perspective view showing the apparatus of the present invention attached to a vessel;

FIG. 1b is a perspective, sectional view showing the apparatus of the present invention without the endcap of the valve body;

FIG. 2 is a side, sectional view of the valve and end plate with the manual trigger actuator attached;

FIG. 3 is a schematic view of the apparatus of the present invention used as an extractor;

FIG. 4 is an exploded view of some of the various parts associated with the valve;

FIG. 5 is a perspective end view of the rear valve operating nut shown in FIG. 4;

FIG. 6 is a perspective end view of the non-rotating spacer and stabilizer pin shown in FIG. 4;

FIG. 7 is a perspective end view of the bushing shown in FIG. 4;

FIG. 8 is an exploded side view of the valve operating rod and valve operating rod cap;

FIG. 9 is an end view of the valve operating rod;

FIG. 10 is an end view of the valve operating rod cap;

FIG. 11 is a side, sectional view showing the endcap of the valve body;

FIG. 12 is a side, partial sectional view of the apparatus of the instant invention showing the means for coupling the apparatus to a ferrule of an apparatus or conduit;

FIG. 13a is a perspective, orthogonal side, sectional view of an adjustable coupling means

FIG. 13b is a side, sectional view of an alternative adjustable coupling means;

FIG. 14 is a perspective, sectional view of a backend plate in position between the valve and the manual trigger actuator assembly the means for coupling;

FIG. 15 is a perspective, side view of the disassembled means for coupling;

FIG. 16 is a perspective sectional view from the rear of the incorporation of an automated pneumatic actuator into the valve-manual trigger actuator assembly;

FIG. 17 is a perspective, sectional view of the manual trigger actuator assembly;

FIG. 18 is a schematic end view showing the inlet passage and outlet passage;

FIG. 19 is a side, sectional view illustrating the positioning of the inlet passage and drain passage of the apparatus of the present invention;

FIG. 20 is a schematic view of the present invention attached to a generally horizontal ferrule;

FIG. 21 is a schematic view of the instant invention showing the apparatus connected to a downwardly sloping ferrule;

FIG. 22 is a schematic view of the instant invention showing the apparatus attached to an upwardly sloping ferrule;

FIG. 23 is a schematic view of the instant apparatus used as a feeder/inoculator;

FIG. 24 is a view similar to FIG. 13 showing the apparatus extending beyond the interior wall of the vessel or conduit;

FIG. 25 is a schematic view showing the operation of certain valves in the instant apparatus; and

FIG. 26 is an example of a timing chart for one operation of the instant invention.

Referring in detail to the drawings and with particular reference to FIG. 1a, a vessel 53 to which the instant apparatus A will be attached is shown. It should be appreciated that the instant invention can be attached to a vessel with a static charge or to a conduit with a static or movable charge. Because this vessel of FIG. 1a is not a part of the instant invention, it is shown in dotted lines. As will be discussed below, this apparatus A can be mounted on the top, side or bottom of the vessel or conduit.

The vessel 53 has a ferrule 1 on the side thereof. Conventional ferrules 1 have a 25 mm internal diameter, for example. A main body 10 of the instant apparatus A has been designed to have an outer diameter generally equal to or slightly less than a standard ferrule diameter. While this 25 mm dimension has been given, it should be recognized that it is merely necessary to have the outer diameter of the body 10 of the instant apparatus A slightly less than the inner diameter of any existing size ferrule. The instant apparatus A of any size can therefore be easily retrofit to existing vessels or conduits with ports of any size. Of course, the instant apparatus can also be assembled to newly manufactured vessels or conduits.

The necessary equipment for either charging a sample to the vessel or conduit 53 or removing a sample from the vessel or conduit 53 is provided through body 10 of the instant apparatus. Therefore, it is not necessary to alter existing equipment when using the instant invention. This arrangement provides for easy retrofit with standard designed vessels or conduits.

Turning now to FIG. 2, the instant apparatus A will be described in more detail. A main sample subassembly 2 is shown connected to back end plate 118 and a manual trigger actuator mechanism subassembly 108. The main bodies of both of these subassemblies can be machined from a single piece of metal (plastic or other material) thereby providing a single, one-piece, unitary structure. By making each of these elements a single piece, the need for several additional junctions can be eliminated with the instant apparatus. Each such junction would represent a potential point for contamination, misalignment or malfunction. However, due to the unique sealing arrangements and overall design of the main sample subassembly and the trigger mechanism subassembly of the instant invention, it is not mandatory to use subassemblies machined from single pieces of metal or other material. These subassemblies can, for example, be permanently affixed (welded, glued, etc.) into single units functioning essentially as single pieces.

The main sample subassembly 2 comprises a body 10 with an internal cavity 3. This cavity 3 includes a sample cavity 11 and a central bore 13 which will be discussed in more detail below.

FIG. 3 shows a control means 4 connected to the apparatus A of the instant invention. This means can be a programmable logic controller, computer operated controller or the like. A part of the control means includes a means for detecting 4a. The operation of this control means 4 and the means for detecting 4a will be described in more detail below.

A supply means 50 is provided for supplying at least one of steam, air and wash medium to the apparatus. This supply means 50 helps maintain an aseptic environment. In some situations, steam alone is sufficient for cleansing the system. In other uses, it is necessary to use pure dry air or a wash medium. Moreover, any combination of these materials can be used. The wash medium can include detergents, alcohol, an alkaline rinse, acid rinse or other wash material. It should be evident that many different arrangements can be used for cleaning and/or sterilizing the instant invention.

The supply means 50 of the instant invention includes a steam feed valve block 5, a pure dry air valve block 6 and a wash medium valve block 7. The steam feed valve block 5 includes a steam source 66 connected to a diaphragm pneumatic valve 67. Also connected to this valve 67 through an electromagnetic valve 69 is a pressurized air source 68. It should be noted that any suitable type of automatic or manual valves 67 and 69 can be used in the instant invention or that these two valves can be combined into a single unit.

The pressurized pure dry air valve block 6 includes a pure dry air source 70. This pressurized pure dry air source 70 is connected to a diaphragm pneumatic valve 71. Also connected to this valve 71 through an electromagnetic valve 72 is a source of pressurized air 73. Similarly to valves 67 and 69, it should be understood that any type of valve can be used for the valves 71, 72. Also, a single unit could replace these two valves 71, 72.

The wash medium valve block 7 includes a supply of wash medium 74. As noted above, this wash medium can be a detergent wash, an alkaline wash, an acid wash, an alcohol wash or any suitable cleansing arrangement. The supply for wash medium 74 is connected to a diaphragm pneumatic valve 75. Also connected to this valve 75 through an electromagnetic valve 76 is a source of pressurized air 77. Again, similarly to valve 67, 69, 71 and 72, any suitable valve or a single unit can be used for these valves 75 and 76.

The electromagnetic valves 69, 72 and 76 are indicated as being connected to the control means 4. It should be noted that the diaphragm pneumatic valves 67, 71 and 75 are also connected to the control means 4. It is merely necessary for the control means 4 to control supply of steam, pure dry air and/or wash medium to the inlet passage 12. Each of these mediums is connected to the inlet passage 12 through the respective valves 67, 71 and 75. Moreover, while three valve blocks 5, 6 and 7 are shown, any of these can be omitted or additional valve blocks could be used as needed. Also, valves 69, 72 and 76 can be combined into a single valve.

The inlet passage 12 is shown as being continuous from the main sample subassembly 2 to the supply means 50. As noted above, this main sample subassembly can be machined from a single block. Appropriate tubing, piping or other connectors can be used to connect the inlet passage 12 bored within the main sample subassembly 2 to the supply means 50. A tri-clamp connection 15 connects this tubing or piping to the inlet passage within the main sample subassembly.

A drain passage 14 is also provided in the instant invention. This drain passage can be bored within the main sample subassembly 2 or can be piping connected to a downstream means for collecting a sample 51 and means for collecting drain 52. These means 51 and 52 will be discussed in more detail below. Similarly to the connection for the inlet passage at 15, the drain passage 14 has connection 16. Rather than using a tri-clamp at the connections 15 and 16, any suitable connection arrangement can be made.

Both the inlet passage 12 and drain passage 14 are connected to the interior sample cavity 11 of body 10. This body 10 not only includes sample cavity 11 but the central bore 13 which together form the above-noted internal cavity 3.

Internal Portion of Valve

From the rear of sample valve 2, the valve operating rod 22 extends forward through the central bore 123 of the back end plate which will be discussed later and into the central bore 13 of body 10 as seen in FIG. 2. Within central bore 13, rod 22 extends forward through a rear nut 28, a spacer 26 and bushing 24. All parts, 22, 28, 26 and 24 are positioned within the central bore 13 along with a pin 25 and are shown in position in FIG. 2. They are also shown individually in FIGS. 4-10. While nut 28, spacer 26, bushing 24 and pin 25 are shown, it should be appreciated that any appropriate arrangement can be used for mounting the valve operating rod 22 in a non-rotating fashion in the body 10. By using such parts 28, 26, and 24, however, assembly and disassembly of the sample subassembly 2 can be easily carried out.

Extending between seat 86 of the spacer 26 and the valve operating rod detent 23 is a spring 27. This spring 27, shown in FIG. 2, will urge the operating rod 22 away from the actuating means located to the rear. This will cause blunt sealing tip 32 of diaphragm 49 to close the orifice 33 as will be discussed in more detail below. By urging the tip 32 in this direction, the instant apparatus will automatically close orifice 33 upon a power failure. Thus, safe operation of the instant apparatus can be ensured.

Turning to FIG. 4, the rear valve operating nut 28, spacer 26, pin 25, bushing 24 and diaphragm 49 are shown.

In FIGS. 4 and 5, the rear valve operating nut 28 is shown. These figures also show seat 43 which will engage the back wall of spacer 26. They also show a hexagonal central bore 78 through rear valve operating nut 28. The valve operating rod 22 will extend through this bore 78. The hexagonal bore of nut 28 shown in the figures receives a (hollow) hex wrench with which it can be tightened against the rear wall of spacer 26 when in central bore 13. Of course, rear nut 28 could have another shape of bore and be fitted with screwdriver slots or other means of tightening. It is merely important that it be able to be tightened up against spacer 26 and that a through hole be provide for free reciprocation of rod 22.

In FIGS. 4 and 6, the spacer 26 and pin 25 are shown. The seat 86 for receiving the rear side of spring 27 on spacer 26 is indicated in this FIG. 4 as well as in FIG. 6. This seat 86 will also engage the rear wall 85b of bushing 24. Spacer 26 has a central through bore 80 as well as a set of other through bores or slots 81. Though FIG. 6 shows spacer 26 with four of these bores 81 located radially at 90 degree intervals, there could be more or less of them. When there are more it is easier to align one of the bores 81 with pin 25 when rod 22 is completely threaded into rod cap 21. The bores or slots 81 mate with a pin 25 which extends into central bore 13. The central through bore 80 of spacer 26 is not circular but, instead, is flattened on the sides. When rod 22 is inserted through bore 80 in spacer 26, its round cross section with flattened sides matches the shape of bore 80 along the length of shaft that will reciprocate through spacer 26. Because rod 22 is inserted through spacer 26 from the rear, all forward portions of rod 22 need to be of diameter small enough to fit through central bore 80. When assembled, the special shape of rod 22 in the vicinity of spacer 26 allows rod 22 to slide back and forth in spacer 26 but does not allow it to rotate. Thus, once rod 22 is screwed into the threads of rod cap 21 in diaphragm 49, and spacer 26 has been slipped on pin 25 so it cannot rotate, and rear nut 28 is tightened down so that the base 29 of diaphragm 49 is fixed, rod 22 is not likely to unscrew from rod cap 21 in diaphragm 49, especially if rod cap 21 is molded into diaphragm 49 during the manufacturing process.

Although spacer 26 when combined with pin 25, will keep rod 22 from rotating, it should be understood that there are several other ways that spacer 26 could be designed to keep rod 22 non-rotational yet still leave rod 22 free to reciprocate through the center bore of spacer 26.

The base of pin 25 is fixed in an annular wall in the center bore 13 of body 10 and protrudes longitudinally to the rear. When spacer 26 is inserted and rotated in center bore 13, one of its lateral holes 81 will align with pin 25 and spacer 26 can be slipped down on it, locking spacer 26 to body 10 and making it non-rotational within body 10. If the bores 81 in spacer 26 are slots, the same effect would be achieved if pin 25 were anchored in the circumferential wall of bore 13, protruding inward.

Spacer 26 can be slid forward until its forward wall 86 engages the rear wall 85b of bushing 24. As rear nut 28 is tightened down on spacer 26, it will push bushing 24 forward which, in turn, pushes the base of diaphragm 49 up against lip 64, anchoring diaphragm 49 and creating an effective seal between the central bore 13 and sample cavity 11. Because spacer 26 is held non-rotational by pin 25, the base 29 of diaphragm 49 is isolated from the torsion forces created by the tightening of rear nut 28 on the back wall of spacer 26.

Pin 25 is a stabilization pin and is a simple cylinder press-fitted into a blind bore in an annular wall within central bore 13 of body 10. It is permanently affixed to body 10. Anything attached to it will, likewise, remain fixed relative to body 10.

A bushing 24 is shown in FIG. 4 and 7. The bushing 24 is divided into a neck 84 and body 85. The neck has a central neck bore 83 through which the valve operating rod 22 reciprocates. It serves as the forward bearing for rod 22. The body 85 has a central bore 82 which houses the primary return spring 27. The forward wall 85a of bushing 24 engages the base 29 of diaphragm 49 and rear wall 85b engages the forward wall of spacer 26.

FIG. 4 shows the parts of diaphragm 49. These include the base 29, the bellows 30, folds 30a, the neck 29a, the blind bulb end 31, diaphragm cavity 38 and the sealing tip 32. The folds 30a of the bellows 30 are sufficiently spaced such that material will not become entrained therein. It should be noted that the diaphragm 49 with sealing tip 32 is not shown in FIG. 2.

In FIG. 4, the base 29 of diaphragm 49 is compressed and secured against the rear wall of lip 64 in central bore 13 by the front wall 85a of bushing 24. Diaphragm base 29 and neck 29a are prevented from collapsing inward by support from within (radial force) produced by slipping the base 29 and neck 29a of the diaphragm over neck 84 of bushing 24 so that it extends into diaphragm cavity 38. Fibers 185 can be imbedded in the base 29 and neck region 29a of the diaphragm. These fibers will stiffen the neck and base in the longitudinal direction and keep them from elongating or compressing in this region as the rest of the diaphragm flexes. The neck 84 of bushing 24 will push the neck 29a against an inner, annular side of lip 64 of body 10 adjacent the central bore 13. The stiffening fibers within the material of the base 29 and neck 29a, combined with the radial forces, helps hold the diaphragm base immobile, forming a static seal on the sample cavity 11 side of lip 64, preventing entrance of the sample, steam, air and/or wash medium into the central bore 13.

As described above, the pressure at 85a of bushing 24 on base 29 of diaphragm 49 is produced by tightening the rear nut 28 on the central bore 13. The spacer 26 transfers the force between nut 28 and bushing 24 and isolates bushing 24 (and the base 29 of diaphragm 49) from the torque produced when nut 28 is tightened.

The central bore 82 of the body of bushing 24 houses spring 27 and the portion of operating rod 22 with spring detent 23. The rear end of spring 27 engages the forward wall 86 of spacer 26 while the forward end of spring 27 engages the rear wall of spring detent 23. Spring detent 23 consists actually of a retainer ring fitted into a retainer ring slot 23a along rod 22. A washer can be added to form a more uniform mating surface with the spring. When rear nut 28 is tightened and spacer 26 is pressed into position against the back 85b of bushing 24, spring 27 is compressed and these forces are transferred forward through detent 23 and rod 22 into rod cap 21 and sealing tip 32, causing sealing tip 32 to seal against orifice 33. Of course, if the operating rod is drawn backward, the spring is further compressed with the results that, when released, the spring tends to bring the sealing tip 32 back to the sealing position on orifice 33. The bulb shape of the blunt sealing tip 32 of diaphragm 49 tends to form a good seal and will help minimize dead space (stagnation area) at sampling orifice 33. Of course this blunt sealing tip 32 can be configured in many ways. It is merely necessary that an appropriate seal be formed with the orifice.

Returning to FIG. 2, the alignment of the valve internal components can be seen. To the rear, alignment for valve operating rod 22 is provided at the central bore 123 in back end plate 118. Valve operating rod 22 extends forward through the rear valve operating nut 28, spacer 26, bushing 24 and into the diaphragm 49. The forward alignment bearing is provided by central bore 83 of bushing 24.

The neck 84 of the bushing 24 provides for a tight support for the base and neck of diaphragm 49. The bellows 30 seen in FIGS. 3 and 4 is shown with a plurality of folds 30a. The base 29 of diaphragm 49 need not be made specifically in the form of the base as seen in FIGS. 3 and 4. If, instead, the bellows are allowed to continue back, they may form into flat immobile base and neck portions. This is due to the bushing neck 84 and forward wall 85a and lip 64.

The use of a diaphragm 49 with bellows 30 and blind bulb end 31 has several benefits. First, all of the moving mechanical parts (such as the valve operating rod 22 and other components associated with central bore 13) are removed from the sample in sample cavity 11. The diaphragm 49 and bellows 30 are made from a biocompatible rubber, plastic or metal material with thermal and chemical tolerant properties. Furthermore, these components are flexible and have a wide range of motion. This great range of motion allows the apparatus to achieve a flush (or penetrating, as shown in FIG. 19) mounting condition on a vessel or conduit, even when retrofit to an existing design. Further, this design allows the blunt sealing tip 32 to be withdrawn from the sampling orifice 33 over a great distance. This facet allows the apparatus to provide minimal sample size bias for samples with particles up to at least six mm size in this particular configuration.

In FIGS. 8, 9 and 10, the valve operating rod 22 and valve operating rod cap 21 are shown. One end of this valve rod 22 has a thick annular groove cut around it, resulting in a short section of narrow shaft, the connector shaft 170. Behind that is the remaining short section of larger diameter shaft, the connector cap 169. On the other end of rod 22 are a set of male threads 87 to mate with the female threads 88 in cap 21. These permit rod 22 to be screwed into cap 21. Of course, other connection arrangements can be made. The previously noted spring 27 will engage the detent 23 of rod 22. Here, detent 23 is a retainer ring riding in a slot 23a in valve operating rod 22. Of course, to provide a more uniform seat for spring 27, a washer could be slipped in between spring 27 and detent 23. Operating rod 22 is shown from the rear in FIG. 9 while FIG. 10 shows it from the front with endcap 21 in place. The connector cap 169 and connector shaft 170 on rod 22 can interlock with an opposing portion of either the manual trigger mechanism or the automated actuator. Together, the two halves form an interlocking mechanism 63 illustrated in FIGS. 14 and 15 and as will be described in more detail below. This is the means of coupling 200 of the actuating shafts. Of course, connections other than these "keyed" connections described here are possible.

As pointed out before, FIGS. 9 and 10 show a rear and front view of operating rod 22 and cap 21, respectively. This valve operating cap 21 and a portion of the valve operating rod 22 will be inserted into diaphragm cavity 38 of the diaphragm 49. This cap 21 ensures that the blunt sealing tip 32 will assuredly seal orifice 33 and not deform and protrude through the orifice 33. Also, this cap 21 will prevent tip 32 from sticking to the area around the orifice 33 when the operating rod 22 is retracted. As FIG. 8 shows, the cap 21 is enlarged such that when it is within bellows 30, it will act to draw diaphragm 49 along with sealing tip 32 away from the orifice 33 in cap 44.

Endcap

The orifice 33 is provided in cap 44 for body 10 as seen in FIGS. 2 and 11. The end of body 10 has set screws 37 for affixing the cap 44 on body 10. It is contemplated that three set screws 37 are inserted through the external walls of body 10 and into cap 44 to hold the cap in position. The threads on each set screw must terminate before penetrating the outer wall of cap 44. They can, however, extend partially into cap 44 as seen in FIG. 11. The ends of set screws 37 can be flat or slightly bowed to prevent damage to cap 44. The three set screws 37 are nonequally spaced around the circumference of the cap 44. In this manner, the cap 44 must be properly oriented before the set screws 37 can be inserted. This "key" effect ensures proper positioning of the cap 44 such that should the valve be an asymmetric version with the centerline of valve operating rod 22 and the other appropriate internal parts as well as cap 21, diaphragm 49 and orifice 33 in cap 44 not coincide with the centerline of body 10, the non-centered orifice 33 in cap 44 will still be properly aligned with the blunt sealing tip 32 of bellows 30 when the cap 44 is mounted to body 10. Of course, if all of these parts are all centered along the longitudinal center axis of the valve and orifice 33 and cap 44 is centered on the valve's longitudinal axis, there is less value in keying the cap. In this case, the benefits in manufacturing savings may favor the use of symmetric positioning of the set screws or their elimination in favor of a threaded connection.

Of course, other sealing arrangements such as a threaded connection, a bayonet or bolt and pin connection can be made even when the valve internals and the blunt sealing tip are positioned asymmetrically within the valve. However, this design has the drawback that incomplete screwing of the cap 44 onto body 10 would result in improper alignment of the blunt sealing tip 32 of bellows 30 with orifice 33. Also, if sealing tip 32 is not retracted while the cap is installed, the rotational movement of the cap 44 during mounting to body 10 might bend rod 22 or damage the tip or some other part of the valve. Therefore, the use of set screws or bolts is preferable to a design wherein the cap is screwed directly onto body 10.

FIG. 11 shows the double walled nature of cap 44. There is an outer wall 190 and an inner wall 191 and a space 192 in between these walls. This space 192 extends from just behind the forward annular wall 90 to a point just forward of o-ring groove 36 and generally parallels inner and outer walls of cap 44. Space 192 provides a more effective barrier to the conduction of heat between interior and exterior surfaces than would be the case if the piece were solid. If a cap were to conduct too much heat during sterilization it would damage the material in the process near or in contact with it. If not for the insulating space 192, that might occur around forward wall 90 and outside wall 190. Without the insulating factor, the cap would also dissipate much of the internal heat intended to sterilize the cap and valve interior so that they might not reach the desired sterilization temperatures. Although in the instant invention this inner space 192 is empty (a vacuum), it could be filled with any material having low thermal conductivity characteristics or structures designed to strategically remove or redirect heat from critical areas such as insulating materials. Alternatively a heat sink could be used. These alternating to space 192 would not detract from the purpose of impeding thermal exchange between the inner and outer walls of cap 44.

The outer wall 190 of cap 44 includes forward annular wall 90 with orifice 33. It also includes side wall 193 with o-ring groove 36. The inner wall 191 of cap 44 includes the interior walls of cap 44, including the sealing area between sealing tip 32 and orifice 33. To improve drainage from orifice 33 down and out of the sample cavity 11, inner walls of cap 44 are inclined as can be seen in FIG. 11. These inner walls could be parallel to the outer walls of the cap 44 if so desired. Drainage in this alternative arrangement would not be adversely affected if the apparatus A were used in an inclined ferrule.

The orifice 33 of cap 44 is formed at the forward end thereof. In cap 44 the orifice 33 must be in alignment with the sealing tip 32. The forward wall 90 of cap 44, is in contact with the interior 61 of the vessel or conduit 53. Although shown slightly recessed, the sealing point of cap 44 with the tip 32 can be substantially flush with the inner vessel or conduit wall 56 of the vessel or conduit 53. It is merely necessary for the cap 44 to have sufficient structural strength to withstand the sealing pressure of the tip 32. In moving in a direction from the outside of the vessel or conduit 53 toward the inside, the less this sealing point of cap 44 is recessed in ferrule 1 and is moved toward the inner wall 56 and interior of the vessel or conduit 53, the less potential there is for development of a stagnation region in front of tip 32. As will be discussed later, the forward end of the valve, including tip 32, can be extended beyond the inner wall 56, where a stagnation layer forms to a greater or lesser degree, into the vessel or conduit interior. By moving the sampling orifice 33 into the body of the fluid, interference from stagnating material along the margins is reduced, increasing the level of quality of representation that the sample has of the bulk of the process. The character of the sample will also correlate better with measurements taken from sensors since their sensing elements are also positioned away from the wall in the bulk of the process.

An o-ring groove 35 is provided in the outer side wall 190 of cap 44 for receiving an o-ring 34 as seen in FIGS. 2 and 11. A similar groove 35a may be provided in the wall of the vessel or conduit 53 for receiving the o-ring. Depending on the vessel or conduit 53 used, this groove 35a can be omitted. The o-ring 34 in groove 35 is capable of forming a seal against the flat surface of the vessel or conduit 53 or against a groove 34a provided therein. Other o-rings and o-ring grooves can be provided to the rear of groove 35 in outer side wall 190 of cap 44 if desired. One set, including o-ring 34a and groove 35a, are depicted in FIGS. 2 and 11. These o-rings and grooves would serve as secondary seals when o-ring 34 in groove 35 serves as the primary seal. If body 10 is installed so as to extend into vessel or conduit 53 interior, beyond stagnant layers 60, one of these other o-rings and its associated groove would then become the primary seal with the vessel or conduit 53. FIG. 24 depicts the valve extending into the vessel interior.

To the rear, outer wall 190 is stepped from the larger diameter down to a smaller one. This smaller diameter, rear portion of outside wall 190 is side wall 193. Just before the rear edge of side wall 193 is another groove 36 for receiving an o-ring 17. The body 10 has a similar o-ring groove 18 for receiving this o-ring 17. Of course, this groove 18 can be omitted. An adequate seal can be formed with or without such a groove 18. If very high pressure conditions are anticipated, a cap with one or more back-up o-rings and grooves can be used or o-rings and grooves can be added along this shoulder. Due to the provision of at least the two o-rings, 17 and 34, a proper seal can be maintained between the sample cavity 11 and the interior 56 of the vessel or conduit 53. In other words, material from the process can only be exchanged with the outside environment through orifice 33 and inlet 12 or drain 14. This exchange can only occur when the sealing tip 32 is retracted. The o-rings 17 and 34 also prevent any process material from getting into the threaded junction 37 where the cap connects to the main body 10.

Sufficient seals should be provided such that leaking, contamination or passive "breathing" is avoided between the seals as noted above. Due to the sealing arrangement, the sample, steam, wash medium or the like will not leak between the cap 44 and body 10 where subsequent samples might be contaminated due to this material leaking back into the sample cavity 11 upon a change of pressure.

Mounting to a Slanted Wall

In the arrangement shown in FIG. 12, the wall 56 of the vessel or conduit is shown as being slanted. It should be appreciated that many different configurations for the vessel are also possible. The forward end of the body 10 and/or cap 44 can be appropriately sloped in order to mate with the interior face of the wall 56.

Coupler

In FIG. 13A, a means 57 is shown for coupling body 10 to ferrule 1. This special screw-type connection can be repositioned along a length of body 10. This coupler, alone, allows body 10 to be fitted effectively, in a flush-mounting condition or otherwise, to ferrules having a variety of different lengths.

Around body 10 and extending for a distance forward from front side 91 are a series of evenly spaced, uniform circumferential positioning grooves 104. Movably positioned in front of front wall 91 of body 10 and around body 10 is a short cylindrical positioning collar 175. Positioning collar 175 has a retainer flange 92 flush with its front wall 91a. Extending through flange 92 in radial fashion are a set of threaded through holes with set screws 178. These are evenly spaced around its circumference. Leading away to the rear from the flange is a smaller diameter shoulder 176. Positioning collar 175 has a uniform cylindrical inside surface which allows it to move smoothly back and forth on body 10 when set screws 178 have been sufficiently loosened. Coupling nut 105, consisting of an internally threaded cylindrical section 106 ending in a short inner annular lip 177, is positioned around body 10, behind positioning collar 175. This inner annular lip is of a smaller diameter then the outer diameter of flange 92 but greater than that of shoulder 176. Thus, coupling nut 105 can be slipped forward over shoulder 176 so that the forward wall of its inner annular lip 177 can engage the rear wall of flange 92 but preventing it from ever passing around flange 92. The diameter of its inner threads are only slightly greater then the outside diameter of flange 92. The length of set screws 178 in positioning collar 175 have been selected so that their heads will be flush with the outer surface of flange 92 only when they are threaded firmly down into one of the positioning grooves 104 on body 10. The forward threaded portion 106 of coupling nut 105, therefore, cannot be slipped forward over set screws 178 and be made to engage with the external threads 107 of ferrule 1 until set screws 178 are all tightened down firmly onto body 10. Coupling nut 105 can then be tightened onto threads 107 of ferrule 1 until front wall 91a of positioning collar 175 engages the rear wall of ferrule 1. With coupling nut 105 tightly fixed to ferrule 1 and covering set screws 178 which are tightened into a groove 104, and because inner annular lip 177 of coupling nut 105 can not slip by retainer flange 92, main sample subassembly 2 is firmly but removably fixed to ferrule 1. Any other subassemblies attached to subassembly 2 will, therefore, also be firmly but removable attached to ferrule 1.

With coupling nut 105 pulled back and set screws 178 sufficiently loosened, position collar 175 can be repositioned along body 10, allowing main sample subassembly 2 to be adjusted to fit different length ferrules or, in a given ferrule, to change its interface with the process from one of flush mounting to one of penetration.

Another means, illustrated in FIG. 13b, though a little more complex and expensive, will now be described. The cross section shown in FIG. 13b only has a detailed showing and reference numerals included for the upper quarter part of the cross section shown. The description follows its assembly onto body 10. First, body 10 has an annular shoulder 181 with a forward wall 91. A short cylindrical retainer sleeve 156 with a set of evenly spaced threaded holes 157 radiating outward, is slid over annular shoulder 181 of body 10 and is retained there by a retainer ring 142 held in a groove 143 in annular shoulder 181 just behind forward wall 91.

A coupling nut 105, consisting of a hollow cylindrical section with a forward internally threaded cylindrical section 106 having an inner annular lip 177 on the rear side thereof, can slide freely around the rear portion of a positioning collar 175. The positioning collar 175 consists of a long, relatively thin cylindrical sleeve or shoulder 176 extending to the rear and with a set of screw through-holes 186 located near but not at its posterior margin. Forward, the positioning collar 175 has a short, double flanged cylindrical section, the outer radiating flange is retainer flange 92 while the inner radiating flange is positioning flange 167 and the forward wall of both of these being the forward wall 91a of positioning collar 175. There are a set of longitudinal through holes 187 bored longitudinally through forward wall 91a and flange 167 adjacent to its inner annular margin. These holes 187 are fitted with countersunk coupler positioning screws 180. These coupler positioning screws 180 are held captive in flange 167 of positioning collar 175 from behind by retainer rings 158 riding in grooves 188 in the screw shafts and from the front by the screw heads which are counter sunk in the forward wall 91a of positioning collar 175.

The coupling nut 105 can be slipped onto the positioning collar 175 from behind and held from slipping off the front by the retainer flange 92. With cylindrical retainer sleeve 156 already in place on shoulder 181 of body 10, the positioning collar 175 with the coupling nut 105 already around it can be slipped around body 10 from the front. Positioning screws 180 can be threaded into the longitudinal holes 189 in the front wall 91 of body 10. When these screws 180 are threaded in holes 189 far enough, screw holes 186 of the shoulder 176 will align with the threaded holes 157 in the cylindrical retainer sleeve 156. At that point, a second set of screws 185 are fitted through holes 186 in shoulder 176 and tightened radially into threaded holes 157 in cylindrical sleeve 156. Once these screws 185 are tightened, coupling nut 105 is captured behind retainer flange 92 of positioning collar 175 on body 10. Furthermore, the position of flange 92 and forward wall 91a which engages the back wall of ferrule 1 during coupling, can be adjusted along body 10 relative to the position of orifice 33 simply by threading screws 180 in or out of holes 189 in body 10. Thus, sampling subassembly 2 can be custom fit to vessels and conduits with a variety of ferrule lengths as well as providing a means to couple the apparatus in a penetrating fashion in a ferrule of given length.

Because the forward advance of the coupling collar 175 is stopped by the engagement of the forward wall of cylindrical retainer sleeve 156 with the rear wall of retainer ring 142 before the longitudinal screws can be threaded out of their respective holes, a user cannot inadvertently disengaged the coupler 57 from the valve, a potentially dangerous event should the vessel then be pressurized.

O-rings and grooves to receive the o-rings can be added along the inside circumferential surfaces of cylindrical retainer sleeve 156 and positioning flange 167 to inhibit this region from collecting dirt.

A third method of removably attaching the main sample subassembly 2 is shown in FIG. 1b. This arrangement is even simpler than the designs shown in FIGS. 13a and 13b. Here, a helical thread 186 is provided around the circumference of the forward end of the main body 10 in front of the front side 91. This thread 186 takes the place of the positioning grooves 104. A positioning collar 175 with a rear annular lip can be threaded on thread 186. This allows for an infinite number of adjustment positions over the threaded range. The threads would not allow the positioning collar 175 to become disengaged unless the collar was threaded too far forward. Such a problem could be avoided by placing a (low profile) retainer ring at the forward end of the threads. When the positioning collar 175 was farthest forward, it would engage the retainer ring. When collar 175 was farthest back, the front wall 91a of positioning collar would be flush with the front wall of this retainer ring.

Of course, there are other methods to removable attach the main sample subassembly 2 and these means can be modified in various ways. An example would be the elimination of the grooves 104 on body 10. Though they provide a certain added safety margin, grooves 104 are not essential for the coupling means to work properly or effectively.

Back End Plate

Engaged with the rear wall 119 of body 10 is the front wall 117 of back end plate 118 as seen in FIG. 14. This engagement creates a static annular seal between o-ring groove 120 and o-ring 121 of back end plate 118 and rear wall 119 around central bore 13. An annular section 122 with a longitudinal axis parallel and coinciding with the axis of the central bore 13 protrudes out from front 117 and rear 130 walls of back end plate 118 as seen in FIG. 14. Cut into the walls of the cylindrical bore 123 of this annular section 122 are one or more annular o-ring grooves 124 (and 125) equipped with o-rings 126 (and 127). A double o-ring arrangement is illustrated in FIG. 14. The rear cylindrical portion 166 of valve operating rod 22 extends through cylindrical bore 123. O-rings 126 (127) form a sliding seal between o-ring grooves 124 (125) and cylindrical portion 166 of valve operating rod 22. Collectively, o-rings 121 and 126 (and 127) seal the inside of the valve from the outside environment and serve as a secondary seal against leaks of the process material to the outside should diaphragm 49 fail. Likewise, they serve as secondary seals protecting the process from the outside environment. Other means of sealing the valve interior from the outside environment could also be used. For example, the seal formed at o-ring 121 between back end plate 118 and rear wall 119 of body 10 could be moved to an annular position on the alignment lip formed by the outside circumferential wall 128 of the forward protruding portion of the annular section 122 in FIG. 14 which mates with circumferential wall 129 of central bore 13. Similarly, the seal created between the cylindrical bore 123 of annular section 122 and the valve operating rod 22 could be made by placing the o-ring grooves in the operating rod. If this latter approach to sealing about rod 22 is chosen, it may be necessary to extend a portion of annular section 122 to a point closer to the back wall of spacer 26 but with a smaller outside diameter so that it fits within the hexagonal bore 78 of rear nut 28. This will allow a longer continuous surface for the o-rings in the cylindrical portion 166 of rod 22 to seal with cylindrical bore 123. One of the advantages of this arrangement is that of providing a longer alignment surface in back end plate 118 to engage operating rod 22.

Once the intent of plate 118 and its seals have been described, it should be clear to anyone familiar with the art that many other sealing arrangements could be used so long as the sealing purpose is achieved.

Assurance of alignment of back end plate 118 with components of the main valve body 10 and, in particular, valve operating rod 22, is achieved by mating of opposing planar surfaces of front wall 117 of back end plate 118 with rear wall 119 of body 10 as well as the close fit of the alignment lip created by the outside circumferential wall 128 of forward protruding portion of annular section 122 mating with an opposing circumferential wall 129 of central bore 13 adjacent to its intersection with the rear wall 119 of body 10. Of course, it should be understood that proper alignment could be achieved in a variety of other ways. These could include: a series of alignment pins or screws in back end plate mating with an opposing set of alignment holes in body 10 (or vice versa); threading outside circumferential wall 128 to mate with the threaded section of central bore 13 behind rear valve operating nut 28; and other arrangements of opposing alignment surfaces or walls machined to relatively fine tolerances.

Back end plate 118 may be secured against rear wall 119 of body 10 directly using screws, clamping or other suitable means or indirectly by being sandwiched between the rear wall 119 of body 10 and the forward wall 168 of an automated actuator housing 41 (shown in FIG. 18) or the forward wall 131 of the trigger housing 109.

Coupling Shafts

In order to allow for easy, fast connection of the reciprocating shafts of each of these subassemblies to one another, a means for coupling 200 has been incorporated into the design. As illustrated in FIG. 14, valve operating rod 22 extends through the central bore 13 of sample valve body 10 and central bore 123 of back end plate 118. Just beyond the rear margin of back end plate 118, rod 22 has a thick annular groove cut around it, resulting in a section of narrow shaft. This narrow shaft is the connector shaft 170. Behind connector shaft 170 is the remaining short section of shaft, the connector cap 169.

The connector cap 169 has a greater diameter then the connector shaft 170 as illustrated in FIG. 15. If the shaft with which it is to mate has a greater diameter then that of the valve operating rod 22, the diameter of connector cap need not be reduced and can have a diameter the same as that of valve operating rod 22 or larger. If, however, the mating shaft has a diameter only slightly larger, equal to or of smaller diameter then that of operating rod 22, connector cap 169 should also have a reduced diameter. However, it still must be larger in diameter then that of the connector shaft 170. This is because connector cap 169 and shaft 170 interlock in the same fashion with either the forward end of the rear valve operating rod 113 at the front part of the manual trigger actuator subassembly 108 or the forward end of the actuator piston 39 of automated actuator 40 as seen in FIG. 16.

Whereas the connector cap 169 and shaft 170 form the "key", the "lock" into which they fit is formed by two perpendicular intersecting slots in the mating actuator rod. The first slot, the shaft slot (171 on the manual actuator in FIG. 15, 171a on the automated actuator, in FIG. 16) for receiving the connector shaft, is cut into the forward end of the actuator rod in a direction parallel and down through its central longitudinal axis. The second slot, the cap slot (172 on the manual actuator, 172a on the automated actuator) for receiving the connector cap 170, is cut through perpendicular to the longitudinal axis. The result is a "T" profile hole into which the connector cap and shaft, also having a "T" profile, can fit as illustrated in FIGS. 15 and 16.

Although these slots can be through slots, the slots of the interlocking connection shown in FIGS. 14, 15 and 16 are not. If the slots are not through slots, the resulting interlocking mechanism will be stronger, more reliable and durable. Besides the quick, easy connect-disconnect nature of this "lock and key" design, this type of connection does not have the rigorous shaft alignment requirements as do other arrangements such as threaded connections.

Once the two shafts are mated, the two subassemblies can be pushed together and secured. The interlocking connection between the two shafts will slide into the central bore of the rear subassembly where they cannot become disengaged until the subassemblies are again taken apart. This arrangement provides a safe, sure and effective connection that, once assembled, cannot inadvertently become disengaged as may be the case with some other connections.

The rear end of the automated actuator piston 39 terminates in a connector cap 169a and connector shaft 170a just like that of rod 22. This allows the user the freedom to attach the automated actuator alone, the manual trigger actuator alone or the automated actuator with the trigger actuator attached behind that, providing an automated system with manual override capabilities. Using this design, switching actuator combinations can be made quickly, easily and without modification of the equipment or interference with the valve's on-line process operation.

Actuator Attachment

As indicated above, manual and automated actuators can be used with sample valve subassembly 2 to operate the valve. The benefits of using automated operators include higher levels of reproducibility both qualitatively and quantitatively over the current manually operated equipment. There is also the benefit of attendant-free operation. But if there is a power loss, a mechanical problem or an unanticipated sampling requirement, automated systems can be clumsy or altogether non-functional. In this case, manual systems are much more dependable, less expensive and do not require the support systems, such as pressurized air, electricity, etc. Then, again, manual systems are not normally as qualitatively or quantitatively consistent and require an attendant to take a sample. Because of the variety of situations that exist and because those situations change with frequency, this system was developed to offer the operator any or all operational options without having to shut down the process to remove and modify the actuators on the valve.

The rear wall 130 of back end plate 118 and the rear wall of the automated actuator 179 are both equipped with a means for aligning and attachment to opposing housings as can be seen in FIGS. 14 and 16. The means for alignment of these subassemblies includes a short cylindrical section 122 (122a with the auto-actuator) projecting rearward parallel with the longitudinal axis of the body and centered about the centerline of the actuating rods on each of the back end plate 118 and the pneumatic operator housing 41. To mate with these, the forward faces of both the pneumatic actuator housing 41 and the trigger housing 109 have similarly placed cylindrical bores or flange through holes 194 to receive them.

The means for attachment of the actuators can be as follows. The front wall 131 of the manual trigger actuator housing 109 can mate with either the back wall 130 of the back end plate 118 or the back wall 179 of the automated actuator housing 41. The front wall 178 of the automated actuator housing 41 is essentially the same as the front wall 131 of that of the manual trigger actuator housing 109, the difference being only that the lower portion of front plate wall 132 has been removed in order to allow trigger lever 111 to start further forward so that it can have a longer stroke. Both of these walls mate with the back wall 130 of the back end plate 118.

FIGS. 14 and 16 show a pattern of holes for receiving bolts with only the pattern of holes 210 within body 10 having internal threads. Furthermore, the holes in the other flanges are through holes 194 while those in body 10 are blind. In this way, body 10 can be fitted not only with the automated actuator, which, in this case, is a pneumatic operator 40, it can also be fitted with the manual trigger actuator mechanism 108 or both together. As an example, installing them both would entail positioning back end plate 118 on body 10 (if it is not already in place) followed by the pneumatic operator housing 41 on back end plate 118 which would then be followed by positioning the trigger housing 109 onto the rear wall of the pneumatic operator housing 41. Bolts 195 would then be passed from the rear through the pattern of through holes in the front plate 132 of trigger housing 109, through the same pattern of through holes in the pneumatic operator housing 41, through the same pattern in the back end plate 118 and into threaded bores 210 within body 10.

Of course, the threaded holes could be eliminated from body 10 and, instead be place in back end plate 118. Back end plate 118, itself, can be attached to body 10 in a variety of ways, including clamps, threads, etc. Here, back end plate 118 is attached to body 10 by a separate set screws 196 in back end plate 118 with a set of matching threaded holes 197 in body 10. Of course, other means by which the opposing faces of these subassemblies are secured to each other could be clamp flanges, bayonet or any other appropriate means.

Manual Trigger Mechanism

As described above, the manual actuator subassembly 108 can either be attached directly to the valve at the back end plate 118 or indirectly through the automated actuator housing 41. Similarly, the rear valve operating rod 113 which is the reciprocating member of the manual actuator subassembly, can be connected directly or indirectly to the valve operating rod 22 as described above. Unlike other manual actuators, however, this manual actuator makes use of trigger action for quicker, more precise control of sample volume and better, more reliable sample quality. The manual trigger actuation mechanism primarily comprises a retracting trigger lever which engages a transverse pin in the rear valve operating rod. As the rear valve rod is retracted, it pulls the forward valve rod attached to the sealing tip back away from the valve orifice, opening the valve.

In its simplest form shown in FIG. 17, the manual trigger actuation subassembly 108 includes a trigger housing 109 having a front plate 132, two side plates, 109a and 109b and a rear plate 109c. Front plate 132 serves as the site of attachment of the trigger subassembly 108 to either the automated actuator 40 or the valve subassembly as described above. Rear plate 109c has an elongated extension which extends downwardly and which serves as a palm rest 110. Of course, front plate 132, side and rear plates 109a, b and c can all be made from one-piece.

A central longitudinal bore 135 through the housing has an axis coinciding with that of valve operating rod 22. Reciprocating within bore 135 is rear valve operating rod 113 which is attached to valve operating rod 22 either directly or indirectly through actuating piston 39 of the automatic operator by the interlocking means 200 described above. Between the two side plates 109a and 109b is the trigger lever cavity 137. Rear valve operating rod 113 extends from inside the central bore 135 in front plate 132, through cavity 137 and out the other side through the rear wall 138 of trigger lever cavity 137. Although central bore 135 extends through rear plate 109c, the rear wall of rear valve operating rod 113 can be shortened so as only to come to a point flush with the back wall of plate 109c when rod 22 and sealing tip 32 are fully retracted. Thus, when the valve is opened, because the end of the rear valve operating rod 113 is always enclosed, it cannot be interfered with or cause injury to anyone who might be near it when it is actuated.

If the return spring 27 used to keep the valve in a fail close condition is not too strong, a trigger lever 111a can be attached directly to the bottom of rear valve operating rod 113 using screws. By placing the palm of the hand on the palm rest and pulling back on the lever with a finger, sealing tip 32 can be retracted from orifice 33, thereby opening the valve. When the lever is released, return spring 27 will automatically close the valve. This design is simple, effective and relatively low cost to manufacture but it suffers from the following flaws.

First, if the return spring is strong, retracting and holding it with one or even several fingers for a period may be hard. Second, because the handle is attached directly to the shaft, if something gets in its way and nobody is around to clear it such as may be the case when using automated operation, the valve may incompletely open or close or not move at all. Also, if someone is standing in the way of the trigger lever when the automated actuator reciprocates the valve, they could be hit and injured by it. Lastly, the lever could be accidentally hit and the valve inadvertently opened. If additional cost is not as important as resolving these problems, then some or all of the following changes can be made to reduce or eliminate these weaknesses.

A more versatile alternative than direct attachment of the trigger lever to the valve operating mechanism is to provide a means by which to adjust the leverage provided by the trigger lever. This would make it easier to use without effecting the valve's sealing characteristics. This can be accomplished effectively if the trigger lever is not coupled directly onto the rear valve operating rod 113. FIGS. 2 and 17 illustrate one such arrangement.

FIGS. 2 and 17 depict a rectangular slot cut through the upper half of trigger lever 111, creating two flat parallel lever arms 146. The lever arms 146 mate with the flat lateral sides 147 of rear operating rod 113. The uppermost portion of each of the two arms of the trigger lever terminates in an annular section 148. A short transverse cam 114, as seen in both FIGS. 2 and 17, is fitted through the two annuli such that it protrudes out through the annuli 148 as shown in FIG. 17. The axis 149 of the transverse cam 114 is generally perpendicular to the longitudinal axis 144 of the rear valve operating rod 113 and cylindrical bore 135. Transverse cam 114 slides along a leverage slot 150 in housing cover 112. Transverse cam 114 contains a transverse threaded bore 151 fitted with the threaded shaft 152 of positioning knob 115. Where it extends below transverse cam 114, threaded shaft 152 extends down between the lever arms 146 of trigger lever 111.

Positioning knob 115 is fixed in housing cover 112 by the placement of the knob retainer ring 116 in an annular slot 153 on threaded shaft 152 on a side of housing cover 112 opposite positioning knob 115. The point of engagement of transverse pin 155 in rear valve operating rod 113 along the length of trigger lever 111 (and, thus, the leverage) can be set by changing the position of transverse cam 114 along leverage slot 150. The position of transverse cam 114 along leverage slot 150 is, in turn, determined by its position along the threads of shaft 152. Consequently, the operator can adjust the leverage of the trigger mechanism 108 simply by turning positioning knob 115.

As discussed earlier, rear valve operating rod 113 is attached to automated actuator 39 or valve rod 22 by the interlocking means 200. Just to the rear of slots 171a and 172a of the interlocking means 200 on rear valve operating rod 113, the sides of the cylindrical rod are milled so as to have two parallel flat opposing external walls 147. The distance between the two arms 146 of trigger lever 111 is slightly more than the thickness between the parallel walls 147 of rear valve operating rod 111. Once installed, rear valve operating rod 113 can slide freely back and forth between arms 146 of trigger lever 111 but cannot rotate because of the engagement of the flat surfaced lateral walls of rear valve operating rod 113 with the opposing flat surfaced arms 146 of trigger lever 111.

Although a non-threaded means of connection was used between rod 113 and rod 22 or piston 39, elimination of rotational motion in this design would permit threaded connections to be used. But this is not the most important aspect of this design. Because the point of engagement of the trigger lever 111 with transverse pin 155 is from the rear and because rear valve operating rod 113 can slide independently backward between trigger lever arms 146, the valve can be actuated automatically without moving the trigger lever 111. Thus, injuries can be avoided during automated operation. Furthermore, transverse pin 155 will always be correctly positioned to engage the trigger lever arms 146 when manual actuation is required. The rear margin 199 of arms 146 of trigger lever 111 where they engage transverse pin 155 have been rounded so as to reduce torque on rear valve operating rod 113 during retraction.

Trigger lever 111 is kept in the forward position and is not carried back with the momentum of an automated retraction of the rear valve operator rod 113 due to the application of forward spring tension acting on the lever arms 146. One end of a small utility return spring 201 is attached by a threaded spring anchor 202 into the inside wall of housing cover 112 while the other end is attached to the two lever arms 146 through two small holes positioned above rear valve rod 113.

To check against inadvertent actuation of the sample valve, a safety catch is incorporated into one side wall 109a of the trigger housing 109. Here, a three-position rocker switch 203 is used. When switching into the "locked" safe position, the right half 204 of the rocker switch is depressed all the way in. This makes the back portion 205 of the rocker wedge in behind the transverse pin 155, locking pin 155 from moving back. When a sample is to be taken, the operator can press on the left half 206 of rocker switch 203 to move it to the neutral unlocked position, freeing up transverse pin 155. Since rocker switch 203 is spring loaded, it will tend to stay in this position until switched again.

If the operator wishes, the valve can also be locked in the "opened" position. This can be accomplished simply by, first, pulling trigger 111 all the way back to fully retract the valve operating mechanism and fully open the valve. At this point, transverse pin 155 is behind the back portion 211 of the left half 206 of rocker switch 203. By depressing the left half of switch 203 all the way to the third locking position and releasing the trigger lever 111, the back portion 211 of the left half 206 of switch 203 will engage transverse pin 155 and hold it there as the return spring returns the valve operating mechanism forward. The rocker switch can also be color coded on the sides so that its exposed surfaces will quick indicate its status.

If adjustments to the spring tension acting on the sealing tip 32 or limitations on the stroke of the valve are desired, a secondary spring return can be incorporated by boring out the trigger housing central bore 135 behind rear wall 138 of trigger cavity 137 and threading it to make backstop bore 145. A retainer ring groove 207 is cut in rear valve operating rod 113 and retainer ring 208 added. A washer 209 is add between retainer ring 208 and secondary return spring 27a which is fitted over the back end of rear valve operating rod 113. Tension is maintained and adjusted by a threaded back stop positioner 140. Back stop positioner 140 comprises a hollow cylinder 182 with a threaded outside diameter which is attached to a cylindrical positioner knob 184 by a annular spacer 183. Parts 183 and 182 have a through bore 141 large enough to accept the diameter of the spring around rear valve operating rod 113. Knob 184 does not have a through bore but to permit independent adjustment of the back stop and spring tension, it can be bored and threaded. A threaded bolt can be adjustable threaded into it to set the back stop position. Otherwise, using backstop 140 to change the backstop position will, at the same time, change the spring tension acting on sealing tip 32 unless secondary return spring 27a is not included in the assembly. By tightening back stop 140 all the way in, it can also be used as a safety lock to prevent the seal formed between the sealing tip 32 and orifice 33 with the process from being broken unintentionally by immobilizing the valve operating rod mechanism 159 in the sealing position.

Alternative Manual Techniques

There are several other methods by which the valve rod may be actuated directly or indirectly.

1) DOUBLE PARALLEL SHAFT

An alternative to the above is to attach a second (alignment) shaft to the rear wall of the valve body 10 with a longitudinal axis parallel but not coinciding with that of valve operating rod 22. This alignment shaft extends further back so that when a finger catch or trigger lever having a rectangular upper portion with two horizontal bore holes is fitted onto the two parallel shafts and retracted to a point that, if coupled to the valve operating rod, would represent a fully open state, the end of the alignment shaft would still extend back to the rear of the rear wall of the rectangular portion.

A retainer ring or other stop is attached toward but not at the end of the valve operating rod 22. A low power secondary return spring to serve as a trigger lever return is slid onto the alignment shaft and kept in place from the rear by the attachment of a palm rest to the end of the alignment shaft. When the trigger handle is retracted, the retainer ring near the end of valve operating rod 22 will engage the rear wall of the rectangular portion of the trigger lever about the bore hole through which it protrudes and retract valve operating rod 22, opening the valve.

An advantage of this design over the one discussed earlier is that the alignment shaft minimizes torque on valve operating rod 22 and its extension. Also, the secondary spring about the alignment shaft assures that the added friction created by the addition of the trigger lever will not affect sealing performance of the valve. Further, an automatic operator can be added to the valve and operated safely, the only exposed part moving being the smooth valve rod, the reciprocating end of which can always be housed in a receiving cylinder in the palm rest. A disadvantage is that there is no means for adjusting the power required to overcome the valve return spring.

2) CABLE ACTION

Still another alternative would be to have the trigger lever rotate about a cam in a housing extending out from the rear wall of the valve body and connecting to the palm rest in the rear, the housing and the connection to the valve being similar to that described above. With one end of a cable, flexible band or other means attached to the top of the trigger lever on the opposite side of the cam from the finger catch, the cable would pass back into the palm rest, around a pulley or other similarly functioning element in the palm rest and pass forward along an axis coinciding with that of the valve operating rod 22. It would attach to the rear of valve operating rod 22 at pin. A rotational trigger lever return spring would tend to keep the trigger lever in the returned position. If the position of the cam can be repositioned along the length of the trigger lever so that the lever arm lengths can be changed, this design has all the advantages of the above as well as leverage adjustment.

Various other arrangements can be arranged using gears assemblies, including rack and pinion designs. These can, however, become complex and expensive, with several moving parts.

Pneumatic Control

The pneumatic automated actuator 40, illustrated in FIGS. 3 and 16 is controlled by the control means 4. This control means 4 can cause movement of the valve operating rod 22 by actuating the pneumatic actuator 40 (in this case, through electromagnetic actuator 212 and pressurized air 213) in order to reciprocate the valve operating rod 22 in the central bore 13. When the manual trigger mechanism is attached to the rear of the pneumatic actuator as was discussed above, and if, for some reason, the control means or automatic actuator should fail, an operator could simply reciprocate the valve using the trigger lever. If the actuator 40 is connected but not to the trigger lever mechanism, the operator could grasp the "keyed" rear end of pneumatic operator piston 39 protruding from the rear of the actuator and use that to actuate the system. Lastly, if the valve is installed with neither the automated actuator or manual actuator available, the valve can still be operated by levering or otherwise grasping and pulling back on the "keyed" end of rod 22 protruding from the rear of the valve.

Probe and Sensor

Returning to FIGS. 2 and 3, a probe 20 is indicated within a probe orifice 19 of the drain passage 14. This probe 20 and orifice 19 can alternatively be located in the sample cavity 11 or alternatively within both the drain passage 14 and sample cavity 11. The probe 20 can be a temperature and/or pressure probe. This probe 20 is operatively connected to the means for detecting 4a of the control means 4.

The means for detecting 4a and probe 20 can provide for independent verification of the various aspects of the system's operation. By comparing a profile of a sampling system temperature or pressure when the system is operating correctly with profiles when various components of the system fail, a determination can be made by the means for detecting 4a of a system failure (abnormal operation). Moreover, a determination can be made by the system as to the severity of the failure and whether to abort further sampling cycles as well as to sound an alarm. The temperature or pressure profile is captured from the probe 20 and fed to the means for detecting 4a. Accordingly, if the diaphragm 49, for example, were to rupture, the probe 20 could determine this condition. Moreover, if there was blockage in the inlet passage 12, this condition could be detected. The means for detecting 4a with the control means 4 can initiate appropriate action. This probe 20 can also detect if an adequate steam temperature has been reached during the sterilization cycle.

Sample Collection

Returning to FIG. 3, downstream from the drain passage 14 is means for collecting sample 51 and a means for collecting drain 52. The means for collecting a sample 51 includes sample drain valve block 8. This valve block 8 has a diaphragm pneumatic valve 93 connected to the sample collector 94. This sample collector can be a sample vial subassembly, for example. Also connected to the diaphragm pneumatic valve 93 is an electromagnetic valve 95 with a pressurized air source 96.

The drain valve block 9 includes a diaphragm pneumatic valve 97 connected to a disposal means 98. Also connected to the diaphragm pneumatic valve 97 is an electromagnetic valve 99 and a source 100 of pressurized air. Similarly to the valves 67, 71 and 75, the diaphragm pneumatic valves 93 and 97 can be replaced by any known valves. Likewise, the valves 95 and 99 could also be replaced by other valves or the valves 93 and 95 and the valves 97 and 99 could be combined into a single unit. The electromagnetic valves 95 and 99 are operatively connected to the control means 4 as indicated in FIG. 3.

Feed/Drain Lines

Turning now to FIGS. 18 and 19, the configuration for the inlet passage 12 and drain passage 14 will be described. To one side of the central bore 13 for the valve operating rod 22 is the inlet passage 12. This inlet passage declines towards the sample cavity 11.

Furthermore, the surfaces facing into the sample cavity 11, when endcap 44 is in place, is generally are angled in a declining fashion such that flow is down and out of sampling cavity 11 through declining drain passage 14. Thus, gravity alone will insure complete drainage of any material entering the valve through either inlet passage 12 or orifice 33 down and out through drain passage 14. Inset within the base of the sample cavity, leading away from the lower rear point of sealing of o-ring 17 in groove 36 of cap 44 with body 10, is a drain collection trough 42 declining to and through opening 48 from internal cavity 11 into drain passage 14. Drain collection trough 42 can actually be an opened extension of drain bore 43 up and into a side of the sample cavity 11, rather than terminating flush with the rear wall at opening 48 into sample cavity 11 as can be seen in FIG. 19. In fact, the collection trough 42 can extend up to the front of the sample cavity 11 if so desired. Thus, drain collection trough 42 and drain passage 14 incline downwardly away from the sample cavity 11. Likewise, inlet passage 12 can also be extended forwardly through the side wall to thereby terminate at or near the forward wall of the sample cavity.

In FIG. 18, the cap 44 has been omitted and the offset of the feed inlet 47 to the sample cavity 11 can be seen. It should be appreciated that central bore 13 may also be offset when physical size constraints in valve design require it (also illustrated in FIG. 19). At such times, orifice 33 of cap 44 will be similarly offset so as to align with the blunt sealing tip 32 of diaphragm 49 positioned on valve operating rod 22.

As can be seen in FIG. 19, the angle of inclination for the drain passage 14 is less than the angle of inclination for the inlet passage 12. Of course this relationship of the angles between the drain passage 14 and inlet passage 12 can vary. For example, a greater angle between the drain passage 14 and axis of the body can be provided than between the inlet passage 12 and the axis of body 10.

Due to the positioning of the inlet passage 12 above the drain passage 14, the position of declining drain collection trough 42 leading through opening 48 to become drain passage 14 as well as the smooth, flush transition between the drain passage and the bottom wall of drain collection trough 42 all with respect to sample cavity 11, a means 45 for preventing accumulation of material in cavity 11 is formed. This means will enable free flow of the sample from the sample cavity 11 to the drain passage 14. Pooling of the sample will be avoided. Therefore, possible contamination of subsequent samples is avoided.

Also, drain passage 14 has an internal diameter of generally 6 mm. This is generally larger than the biggest sample particle drawn from vessel 53. In that way, clogging of the drain passage 14 is avoided.

As seen in FIGS. 18 and 19, due to the offset mounting of inlet passage 12 and outlet passage 14, it is possible to squeeze each of these items within the 25 mm constraint for the outer diameter of body 10. In this manner, the body 10 can be retrofit into an existing apparatus. As noted above, the inner diameter of ferrule 1 is typically 25 mm in many devices. While this dimension can change, it should be understood that the instant invention can be inserted into existing equipment without the need for retrofitting this equipment. Of course, when larger or smaller ferrule ports exist, the instant invention can be made larger or smaller to accommodate these ferrules with correspondingly larger or smaller components.

Angles of Installation

In FIGS. 20-22, mounting of the apparatus of the instant invention is schematically represented. If the instant apparatus is to be mounted in a horizontally oriented ferrule 1 as shown in FIG. 20, the longitudinal axis 65 of the body 10 will be generally horizontal. The longitudinal axis 59 for the inlet passage 12 will be offset from axis 65 by an angle of approximately 18.5.degree.. The longitudinal axis 58 for the drain passage 14 will be offset from the longitudinal axis 65 of the body by approximately 3.degree.. Therefore, the slope for the inlet passage 12 is greater than the slope for the drain passage 14. This helps to ensure proper drainage of the sample, steam, air, wash medium and/or condensate.

As shown in FIG. 21, if the ferrule 1 is sloped downwardly, for example, by 15.degree. from the horizontal plane h, the longitudinal axis 65 of the body 10 will similarly be offset by 15.degree.. Such a downward slope of 15.degree. is a standard design for some ports in vessels or conduits 53. With this downward inclination, the longitudinal axis 58 of the drain 14 will be offset about 18.degree. from the horizontal plane h. The longitudinal axis 59 of the inlet passage 12 will continue to have a downward slope. This axis 59 will be offset from the horizontal plane h by approximately 3.5.degree.. Therefore, with a downwardly oriented ferrule 1, proper flow can continue to be had with the instant invention. Pooling of the sample and steam, air, wash medium and/or condensate can be avoided in this arrangement.

In the upwardly inclined ferrule 1 of FIG. 22, the longitudinal axis 58 of the drain would have less of a slope than the longitudinal axis 59 of the inlet passage 12. Nonetheless, this arrangement continues to urge material through the system. For situations where the ferrule is sloping upward at an angle greater then the 2.degree., effective drainage can be accomplished in either of two ways. The first is by means of extending a tube up to orifice 33 and overpressuring the valve, in effect, vacuuming the sample out by the low pressure created around the mouth of the extension of the drain line. The second method is to have a greater angle of declination on the drain line and a lesser angle of inclination to the feed line.

Process Control

Process control for the instant invention is carried out under the direction of the control means 4. As noted above, this control means 4 can be a programmable logic controller, computer operated controller or any other suitable control means. The control means 4 permits the appropriate sequencing of the various valves of the instant invention. Collectively, the system sequences and times the opening/closing of each valve as well as the sampling device but will allow an operator to program the length of time each valve will remain open. This provides a means by which the process control system can be adapted and incorporated into a variety of different process applications.

Different sized valves, different materials of construction, different process flow temperatures and flow rates different cleaning or chemical agents (steam, air, wash medium, etc.) and other process materials can influence the proper timing of the various facets of operation (sampling, cleaning, sterilizing, resampling, etc.). A single cycle sequence of the basic components of the system of the instant invention will now be discussed.

The control means 4 controls the functioning of the main sample subassembly 2 in tandem with the five peripheral process flow control valves 5, 6, 7, 8 and 9. The control sequencing is laid out in FIGS. 25 and 26. This sequence is designed to clean and sterilize the inlet passage 12, main sample subassembly 2 and drain passage 14 before each sampling. This system will also purge the last of the sampling material into the disposal means 98. After the blunt sealing tip 32 closes orifice 33, the system will also be cleaned and resterilized between each sampling.

The pure steam feed block 5, for example, will control the flow of steam to sterilize the system. Likewise, the pure air feed block 6 will control the flow of pure air through the system for two purposes. First, this air will be blown through the inlet passage 12, sample cavity 11, drain passage 14 and to the disposal means 98 such that any sampling material that might remain after a sampling is removed. This air is also blown down the drain passage 14 such that any steam condensate that remains after the sterilization phase is completely removed. The pure air will both cool and dry the sampling system before the next sample is taken. The wash medium can be provided by the wash medium valve block 7 to clean the system if steam is insufficient. Likewise, a combination of steam and wash medium can be used. The pure dry air 70 can also be used to help flush the wash medium from the system and to dry the system after the use of wash medium.

The drain line block 9 will be open to drain away condensate, wash medium and the like during cleaning and sterilization. The sample vial block 8, on the other hand, will be open to allow the sample material to flow into the sample collector 94.

In FIG. 25, valves 49, 71, 67, 93 and 97 are indicated by SO, V1, V2, V3 and V4, respectively. As indicated in FIG. 26, a waiting period will first be encountered during one type of sampling operation. The valve indicated as V1 and V4 will be open. In other words, the diaphragm pneumatic valves 67 and 97 will be open. Steam will rush from source 66 through inlet passage 12, sample cavity 11 and out drain passage 14 to the disposal means 98 while valve 97 is still open. After an appropriate period of time, the valve 67 will be closed and the valve 71 will be open. Pure dry air can then rush through the system to the disposal means 98. This pure dry air will not only force any remaining particulate matter through the system but will also aid to cool and dry the interior of the apparatus.

In the timing chart of FIG. 26, a one-second delay is then indicated. It should be recognized that this delay could be omitted or could be for a shorter or longer duration. Sampling will next take place. In this arrangement, the valve S0 and V3 are indicated as being open. In other words, the valve 49 will be opened to permit the sample to exit the vessel or conduit 53 through the port 54 thereof. The material will move through orifice 33 into sample cavity 11 and down drain 14 to the sample collector 94. While it is not shown in the FIGS. 25 and 26 arrangement, it should be noted that the valve 93 can initially be closed and the valve 97 opened such that a first portion of the sample will actually go to the disposal means, if so desired. In any case, valve 97 should close before valve 93 opens.

No valves are provided in the interior of the sample cavity 11 for preventing the sample from entering the inlet passage 12. The valves 67, 71 and 75 will be closed such that an internal pressure will be sufficient to prevent the sample from traveling up inlet passage 12. Moreover, gravity also prevents the sample from traveling up the inlet passage 12. The apparatus A is therefore simplified and can be used in existing vessels or conduits 53 without modification due, in part, to the omission of extra valves. In other words, the relatively small size of body 10 can be maintained such that it is compatible with existing vessel or conduit ports. Moreover, potential sites of contamination are avoided by omitting such additional valves.

After a sufficient sample has been collected at collector 94, another one-second delay is indicated in FIG. 26. Again, no delay or a greater or lesser time period can be provided. The valve 49 indicated by SO in FIG. 26 is then closed and the valve 71 is opened. Pure dry air will then rush through the system in order force the sample in cavity 11 and drain passage 14 into the sample collector 94. Accordingly, one operation of the apparatus of the instant invention has been described. It should be understood that the wash medium valve block 7 can also be operated if so desired. However, in the arrangement of FIG. 26, the wash medium from source 74 is not used.

As previously noted, the arrangement in FIG. 24 (and FIG. 3) shows the body 10 of the apparatus being inserted into a vessel or conduit 53. When stagnant layers 60 may be present in the vessel, a mounting arrangement shown in FIG. 24 can be used. This design places orifice 33 beyond these stagnant layers 60. The apparatus used in the design of FIG. 24 is similar to the arrangements of FIGS. 2, 13A or 13B. If the user will never install the valve in a penetrating fashion, the cap 44 need not have two o-rings and grooves on its outside circumference and cap 44 need not be quite as long as is shown in these figures. However, if two grooves are used, a single o-ring 34 can be moved between the two grooves 35 or 35a as needed. Of course, two separate o-rings could be provided, one for each groove. However, when the apparatus A is positioned as shown in FIG. 24 (or FIG. 3), it is preferred to omit an o-ring from the forward groove 35. In this manner, it is less likely that material would become trapped at the forward, outer end of the cap 44.

It should be appreciated that after the body 10 is mounted in the arrangement of FIG. 24, this body 10 is not movable once mounted. Rather, it extends within the vessel or conduit 53 for the predetermined distance indicated during its operation. Of course, when this device is no longer needed, the means 57 for coupling can simply be detached and this apparatus removed from the vessel or conduit 53 and readjusted. Due to the forward o-ring groove 35, this body 10 can be mounted substantially flush with the wall 61 of the vessel or conduit 53, too. The o-ring groove 35a with o-ring 34 will form a seal between body 10 and vessel or conduit 53 when the apparatus A is extended as shown in FIG. 24. Alternatively, when the face of cap 44 is generally flush with the interior 61 of vessel or conduit 53, an o-ring in groove 35 will form a seal between the apparatus A and the vessel or conduit 53. The o-ring 34 can be moved from the rearward groove 35a to the forward groove or a new o-ring 34a can be inserted in groove 35 while the rearward groove 35a may or may not retain the o-ring 34.

Feed/Inoculation Means

Up to this point, the instant invention has been discussed as a sampling apparatus. As shown in FIG. 23, this instant invention can also be used as a feed/inoculation means. In FIG. 23, the apparatus A is mounted on the top of vessel 53. When used as a feed/inoculation apparatus, the instant invention can also be mounted on the side of vessel 53.

The feed/inoculation arrangement shown in FIG. 23 is similar to the sampling arrangement previously discussed. However, the drain passage 14 extends well into the sample cavity 11 to prevent pooling of the sample or cleaning material in this arrangement. The opening 48 for drain passage 14 is generally adjacent the wall of cap 44 having orifice 33.

As indicated in FIG. 23, means 101 is provided for feeding the sample. This means 101 will supply the sample through the inlet passage 12, sample cavity 11, orifice 33 and into the vessel or conduit 53. After the sample has been charged to the orifice or conduit 53, the sealing tip 32 can be moved to close orifice 33. Then the supply means 50 can feed steam, dry air and/or wash medium through the inlet passage 12, sample cavity 11 and out of the drain passage 14 to the means for collecting drain 52.

Indicated schematically in FIG. 23 is a switching means 102 utilized with the supply means 50 and means 101 for feeding sample. This means 102 selects whether the means 101 will supply the sample through the inlet passage 12 or whether the supply means 50 will clean and/or sterilize the inlet passage 12 and other downstream structure.

Apart from having the end 48 of the drain passage 14 located at the end of the sample cavity 11, the diameter of the drain passage 14 is of a sufficiently small diameter such that the pressure in sample cavity 11 (created from inflow through passage 12) will be sufficient to force any material fed through inlet passage 12 up and out drain passage 14. In this manner, the particle size of the sample fed to the sample cavity 11 is limited by the size of the inlet passage 12. When the supply means 50 is operated, sufficient air, steam, and/or wash medium can be fed through the inlet passage 12 in order to force any sample or other contaminant through the drain passage 14 to the means for collecting 52. Otherwise, the design of the feed/inoculation arrangement shown in FIG. 23 is similar to the sample assembly previously discussed.

Advantages

The instant apparatus A has several advantages. Its geometry will enable the body 10 and its contents to be relatively small such that it can be retrofitted into existing vessels or conduits. For example, the 25 mm standard size for ferrules 1 can be accommodated with the instant invention.

The instant invention provides a uniquely designed biocompatible, resterilizable flexible diaphragm which allows the sample extraction orifice to be flush mounted with or penetrated into the vessel or conduit 53. A customized subassembly design is possible in which all of the contamination-prone opposing sliding/rotating surfaces are sealed from the sample. For example, the bellows 30 separates and isolates a sample from the operating portions of the valve 49. Other control features such as the steam feed valve block 5, pure dry air valve block 6 and wash medium valve block 7 are removed from the sample. Since contamination-prone parts are removed from the process, the instant apparatus A is a more effective overall sanitary design.

The instant apparatus A is free-draining and will avoid pooling. Pockets between the sample cavity 11 and the drain passage 14 are not present such that pooling or accumulation of a sample or drain is further avoided.

With the exception of seals about the cylindrical sealing portion 166 of rod 22, all secondary seals are static to provide the most effective barrier to leakage within the system and/or to the outside environment. Further, the interfaces between the abutting surfaces on the process side (where crevice-related carryover contamination often occurs) are sealed with the static seals (with the exception of the specially designed primary seal which is a diaphragm-type seal). The instant invention avoids the need for dynamic o-ring seals. Void volume in the sample cavity 11 is minimized. Tortuous flow is also avoided. Therefore, minimal loss of sample material during the sampling process and maximized reproducibility and accuracy of measured samples is had with the instant invention. By using small volumes, only small errors in measurements will be made.

Within this 25 mm outside diameter design discussed, the instant design permits particles of at least six mm outside diameter particles to pass from the vessel or conduit 53 through the sample cavity 11 and out of the drain line 14 to the sample collector 94. Therefore, physical distortion of the sample constituents is avoided, thereby assuring that samples taken are not biased due to size exclusion.

The trigger mechanism, which allows the valve to be rapidly opened and closed, allows more precise control of sample volumes and, at the same time, reduces sample waste. Furthermore, because sample volumes can be controlled much more precisely, even small volumes, operators will not have to resort to "throttling" which can cause physically and chemical changes in samples through shear. Lastly, the trigger actuator mimics the action of automated actuators. This means that its samples will correlate better with those taken using automated actuators then will other manual actuator designs.

The trigger mechanism and or the automated actuator can readily be added or removed from the valve, providing easier maintainability. Furthermore, because the valve is sealed and has the primary return spring within, these change-out operations can be done without affecting the valve's on-line service.

All static threaded connections and abutting surfaces of the instant invention are placed behind static o-ring seals. This removes trouble-prone interfaces from contacts with process flow.

The control means 4 and means for detecting 4a of the instant invention provide for automatic sampling or inoculation. Therefore, operator error is avoided. Manual override also permits sampling even in the case of power failure.

Pressure or temperature profiling of the system and independent indirect verification enables a more reliable operation.

Accordingly, with the instant invention, an accurate subsample of the process composition can be had. This arrangement can be used with existing systems or with new systems. Maintenance of the instant apparatus can easily be carried out.

Because the body 10 of the instant invention can be machined from a single piece of metal, plastic or other material, if so desired, the need for additional junctures is eliminated. This also avoids potential points for contamination to the sample. Also, the bulb design of the sealing tip 32 avoids dead space.

Due to the control means 4, the timing sequence can easily be changed. For example, an operator can change the length of each of the phases in the sampling process and, using feedback from the temperature and/or sensor probe 19, determine if any error has occurred in the system.

The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.