Patent Publication Number: US-2007114484-A1

Title: Sanitary drain valve design

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
      This application is a Divisional of Co-pending application Ser. No. 11/165,169, filed Jun. 24, 2005, which is a Continuation of Co-pending application Ser. No. 10/633,358, filed Aug. 4, 2003, which is Continuation of Co-pending application Ser. No. 10/290,542, filed on Nov. 8, 2002, now U.S. Pat. No. 6,601,823, which is a Divisional of U.S. application Ser. No. 09/801,783, filed on Mar. 9, 2001, now U.S. Pat. No. 6,491,283. The entirety of each of these applications is hereby incorporated by reference. This non-provisional application also claims priority under 35 U.S.C. § 119(a) on-U.S. Provisional Application No. 60/187,996 filed in on Mar. 9, 2000, the entirety of which is hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION  
      1. Field of the Invention  
      The present invention is directed to an improved sanitary valve design. In particular, the present invention is directed to a sanitary valve design that allows for free-drainage of process and sterilizing and cleaning materials.  
      2. Description of Background Art  
      There have been many incidents where sanitary processes have failed, resulting in loss of product. In some cases, harm to consumers occurs. In many instances the specific nature of the source of contamination remains unidentified. In many other instances; however, the source of contamination has been traced back to drain valves, which have not been properly cleaned, and in many cases where procedures specify it, sterilized between production runs.  
      Failures have not been limited to valve designs traditionally viewed as being problematic when used in sanitary applications (tulip and kettle valves, plug and ball valves, e.g.) but, rather, extend to include weir and radial diaphragm valve designs which are currently considered state-of-the-art designs particularly suited for sanitary processing applications.  
      The causes for these failures, almost without exception, relate to material accumulation in low, undrainable pooling areas and in tight crevice areas, particularly those associated with moving parts such as sliding or rotating O-ring seals. Deep, tight joints, particularly around moving parts, are primary sites for material to accumulate and are ideal safe havens for microbial proliferation. These sites can become tightly packed with highly nutricious process materials, which provide insulation and protection from cleaning and sterilizing agents, allowing significant microbial populations to develop over time. Deposits of tightly adhering organic and inorganic material resist the effects of caustic and acidic cleaning solutions, mechanical shear from agitation and high rates of circulation and from the effects of steam sterilization. Large deposits may develop in valves over time, a consequence of the selection of valves emphasizing design robustness and mechanical reliability over in-situ process cleanability and sterilizability. Cleaning and sterilizing followed by the initiation of process production may cause large deposits or accumulations to soften and slough or break off, getting blended into downstream process materials, representing significant contamination to the process. These large deposits are of particular concern because they represent contamination threats large enough to significantly affect product quality and process outcome even for processes traditionally considered very robust, such as some food, beverage and chemical production.  
      If gone undetected, product exposure can, in some cases, be harmful or even fatal. For this reason, regulators as well as the regulated industry have begun to look more closely at the source of the problem and search for ways to minimize it. An important part of this effort has been to implement more active preventative maintenance and inspection programs for valves. At some point, however, increasing human intervention becomes impractical and cost-prohibitive. Another part of the effort has been to re-examine the root cause of the problem. Specifically, the performance of current valve designs in sanitary process applications where valve maintenance efforts between production runs has been practically limited to in-situ cleaning, rinsing and steam sterilization.  
      As it turns out, process failures, although strongly skewed toward processes which have included valve designs which are dependent on sliding or rotating O-ring seals (i.e. ball valves, plug valves, tulip valves and kettle valves, have not been limited to these designs. Aoki, U.S. Pat. No. 3,949,963 and Lerman et. al., U.S. Pat. No. 4,822,570 disclose some typical examples of valve designs which may experience process failures. Even though many of the new sanitary processes being implemented include state-of-the-art weir diaphragm and radial diaphragm drain valve designs, failures still persist in these processes, albeit at a decreased rate. Typical examples of the above valve designs are Butler et. al., U.S. Pat. No. 5,277,401, Hoobyar, U.S. Pat. No. 5,152,500 and Ladisch, U.S. Pat. No. 4,836,236.  
      Diaphragm valves, with flexing diaphragms that allow valve actuation while isolating the process from moving valve parts and the surrounding outside environment, generally include less crevice areas and have smooth surfaces, all of which make them the best candidates available for use in CIP (clean-in-place) and SIP (steam sterilize-in-place) sanitary process applications. Of the other, more traditional valve designs, tulip and kettle valves are most frequently found in sanitary process applications. These valves are relatively inexpensive to install and maintain and are simple and mechanically reliable. Furthermore, even though they have more crevices as compared to diaphragm valves, it had been thought that their benefits were greater than their weaknesses and their weaknesses were not so serious as to restrict their use in processes requiring CIP and SIP steps before each batch, particularly in the more robust, food, beverage and chemical processing applications.  
      Inspection of valves commercially available today and of the background art reveal certain features common, not only to those drain valves making use of O-ring seals but also to both types of diaphragm drain valves. In particular, the seals formed between the valve body and the diaphragm or O-ring are made with the second, lower side of the bottom wall of the valve body internal cavity. As a result, the thickness of the bottom wall between the first (process) and second (non-process) sides form the wall of a well which is not possible to drain and serves to entrap and shelter process material, cleaning agents, rinse water and steam condensate. In some diaphragm designs, this well, though very large in diameter and, therefore, capable of harboring a large volume, relatively speaking, most areas can be washed clean except for the area immediately adjacent to the well wall. The problem associated with valves equipped with O-ring seals is, generally speaking, just the opposite. The wells above the seals tend to be very narrow because of the need for tight tolerances and a relatively close fit between the valve operating rod and O-ring/O-ring groove combination. Although the volume of the well tends to be much less, effective access for proper CIP and SIP procedure execution is not consistently possible.  
      Another problem area of valves associated with the design of bottom seal devices is their general tendency to have at least partially flat bottom walls to the valve internal cavity. While these walls may make these valves easier to fabricate, flat surfaces do not contribute to achieving positive drainage of materials from within the valve. Standing fluids, in many instances, can be as large of a threat of contamination as entrapped material, sometimes more because of the presence of large amounts of water, an important ingredient for microbial proliferation.  
      While the devices mentioned in this discussion may have certain weaknesses when used as drain valves or similar applications in sanitary processes, they may be perfectly adapted for other applications. It is the author&#39;s intent, however, to describe a valve design which includes several novel features which are flexible in concept and lend themselves to the improvement of more traditional drain valve designs. Among these are the elimination of the seal well in the bottom wall of the valve internal cavity which can be combined with the introduction of a bottom surface sloped toward the drain opening so that the bottom wall of the valve will actively urge process material, cleaning solutions, rinses and steam condensate to flow down and out of the valve. Other features include the option of rearranging secondary inlets and the drain outlet so as to encourage a swirling, scouring action of materials flowing through the valve so that more effective CIP and SIP results can be achieved. The new design will be illustrated in both diaphragm and O-ring type seal designs.  
     SUMMARY OF THE INVENTION  
      An object of the present invention is to provide an improved general valve design having good characteristics of process isolation and in-situ cleanability in many orientations as well as providing specific improvements in cleanability and drainability performance capabilities over the background art when used in conduit or tank bottom valve applications.  
      Another benefit of the present invention is an improved, free-draining, cleaner sealing arrangement for tulip, kettle and other O-ring-based seal designs, it also being possible to clean and sterilize the sealing arrangement from the back, non-process side independently from the process side on a descript or continuous basis, even while the valve is being operated.  
      A further object of the present invention is to provide a valve that can be mounted directly on the bottom of a tank, and, in the diaphragm configuration, can provide absolute isolation of the process from the valve components and the outside surrounding environment. Furthermore, in the case of o-ring designs, the present invention can provide a high degree of isolation of the process from the valve components and the outside surrounding environment.  
      A benefit of the device of the present invention is that it provides a smooth, crevice free flow path, which will permit very highly effective drainage of process material from a tank or conduit.  
      Another object of the present invention is to provide a design that can be flush-mounted, thereby eliminating the formation of dead zones at the inlet into the valve.  
      Yet another object of the present invention is to provide a valve design where process material, cleaning solutions, rinse water and steam condensate drains down and away from the seal formed between the valve body and the sealing body (diaphragm or O-ring), eliminating the undrainable well or sump area that occurs in the prior art where material collects and is difficult to remove.  
      Another object of the present invention is to provide an internal valve body design with a second inlet positioned in the same plane or above the outlet and directed so that flow from the second inlet flows into, around and out of the internal cavity of the valve in a circular or spiral path so as to provide improved CIP and SIP performance.  
      Still another object of the present invention is to provide a design that can be actuated manually or automatically and which can be opened partially or fully, thereby allowing the valve to be used to regulate flow.  
      A further benefit of the valve design concept of the present invention is that it can be employed in many design forms all of which may provide diaphragm isolation in combination with drainable seals and internal valve cavities.  
      Yet another object of the present invention is a valve body design that can be fabricated as a single piece  
      Still another benefit of the present invention is that the same valve body may be used in many different installation configurations, because the connection flange may be constructed as a separate piece from the valve body, allowing it to be changed to fit a clamp or bolt pattern already installed on the vessel or conduit.  
      An additional benefit of the present invention is that the diaphragm arrangement valve may be constructed of many types of material so as to impart flexibility of manufacture and use in a variety of different material processes.  
      A further benefit of the valve design concept of the present invention is that it illustrates how the diaphragm may include single or multiple sections, and guidance on how those may be incorporated into sealing arrangements in the valve in order to provide a greater range of motion for the sealing tip of the valve even when the diaphragm membrane may exhibit greater or lesser degrees of rigidity, flexibility or elasticity.  
      Another benefit of the valve of the present invention is that it may be rotated 360 degrees so as to provide greater installation versatility.  
      Yet another purpose of the present invention is to provide a simple, economic design that may easily be disassembled for maintenance purposes.  
      Another object of the present invention is to provide a design that can be used to great effect over other prior designs in installations and applications other than tank or conduit drain applications and where superior clean-in-place and sterilize-in-place as well as drainability characteristics will be demonstrated.  
      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. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      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. 1  is a cross-section of a 1-piece “Mushroom” diaphragm valve in closed position, with a second inlet feeding to the internal cavity through the valve body side wall, above the drain opening;  
       FIG. 2  is a cross-section of a 1-piece “Mushroom” diaphragm valve in an opened position, with a second inlet feeding into the internal cavity through the cover plate from a radial position;  
       FIG. 3  is a perspective view in cross-section of one alternative diaphragm design offering a greater range of motion through the incorporation of a bellows;  
       FIG. 4  is a cross-section of a 2-piece “Mushroom” diaphragm valve;  
       FIG. 5  is a close-up cross-section of the 2-layer diaphragm sealing device mounted in the cap;  
      FIGS.  6 ( a )- 6 ( e ) are central cross-sections of examples of other diaphragm sealing arrangements;  
       FIG. 7  is a cross-section of an example of inverted sealing technology applied using a diaphragm in a tulip valve configuration;  
       FIG. 8  is a cross-section of an example of the inverted sealing technology applied in an O-ring configuration to a tulip valve design and incorporating CIP/SIP capabilities to the non-process side of the seal as well as the process side; and  
       FIG. 9  is a cross-section of an example of the inverted sealing technology applied in an O-ring configuration to a plunger valve design and incorporating CIP/SIP capabilities to the non-process side of the seal as well as the process side.  
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      In general, the device of the present invention includes a valve body equipped with a manual, automated or combination actuator capable of moving a sealing tip attached to a valve operating rod reversibly into a sealing condition with a valve seat surrounding a first inlet flow passage into an internal cavity in the valve body. The valve body has at least one outlet flow passage placed at the bottom of the internal valve body cavity to receive drainage, the bottom preferably but not necessarily being cantilevered or otherwise formed so as to assist drainage down to at least one outlet flow passage. A seal is formed between the static valve body and the dynamic valve actuating rod in which, whether an O-ring seal or diaphragm seal is used, the interface between the sealing elements is carried out in a face-down configuration so as to create a self-draining sealing interface and to eliminate the pooling that is associated with sump or well areas that occur in the annular space above the face-up seals found in the background art. One preferred arrangement of the device includes a second inlet which is placed near the top of the internal cavity, near the first inlet but spaced radially from it, a bottom outlet placed at the bottom of the internal cavity, the opening of the second inlet and the opening of the outlet being diametrically opposed with regard to flow in such a way that flowable material fed through the second inlet will spiral down and around, sweeping and scouring the sides of the internal cavity before flowing directly into the facing bottom outlet. The device will be described in detail below in some of the various configurations it may be designed into once the main concept of the present invention is understood.  
      A valve design arrangement will be described which includes a one-piece flexing diaphragm with a sealing tip which, when actuated by a valve operating rod, cause the sealing tip of the diaphragm to form a reversible process seal with the valve body so as to permit control of process flow through the valve all while maintaining the integrity of the process separate from that of the valve and the surrounding outside environment.  
       FIG. 1  is a center cross-sectional view of one preferred embodiment of the device of the present invention, shown in position as a bottom drain valve. As shown, valve assembly  1  includes a valve body subassembly  2 , diaphragm subassembly  3 , valve actuator rod subassembly  4  and actuator device  5 , which, in this case, is a manual actuator. It should be noted that all of the internal passages of the valve which are in contact with the process material should be rounded in order to avoid any sharp corners where the process material, cleaning materials, steam, etc. may accumulate. Several of the Figures in the present application illustrate sharp corners, although it is preferable that curved corners be included.  
      The valve body subassembly  2  will now be described. The valve body subassembly  2  includes a valve body  10  and a cover plate  100  which are connected together by an attachment device  107 . Valve body  10  has an internal cavity  11  with a bottom wall  12  having an upper first side  85  and a lower second side  86 , upper first side  85  being exposed to the process, lower second side  86  being removed from the process. Internal cavity  11  or valve body  10  is in communication with at least one drain outlet  30  and at least one first inlet  20 . The drain outlet  30  is in communication with a drain passage opening  31 .  
      The upper surface  102  of cover plate  100  forms a portion of a wall or drain basin  103  of a tank or conduit (not shown). The lower surface of cover plate  100  forms a roof  13  of the internal cavity  11 .  
      In the example shown, first inlet  20  is centered at the bottom of drain basin  103  having a bottom formed by the upper surface  102  of the cover plate  100 . A second side of the cover plate  100  forms an uppermost side or roof  13  of internal cavity  11 . The annular surface of roof  13  immediately adjacent the first inlet  20  forms an inlet annular sealing surface  21  with which a seal is reversibly formed when mated with an annular diaphragm sealing tip surface  63  on an actuating cap or sealing tip  83 .  
      It should be noted that  FIG. 1  illustrates roof  13  with a conical profile that tapers up to the first inlet  20 . Although not a necessity, the taper can improve flow through the valve and serve as a guide to center the annular diaphragm sealing tip surface  63  onto the mating inlet annular sealing surface  21 .  
      By way of example, cover plate  100  is illustrated with upper flanges  105  welded into a wall of a conduit or vessel (not shown). However, cover plate  100  may take many other forms such as, for instance, a sanitary ferrule with an internal diameter the same as the diameter of the first inlet  20  and to which the valve assembly could be attached.  
      In addition, cover plate  100  can be attached to the valve body  10  by an attachment device  107  such as a bolt  108  and threads  109  as shown in  FIGS. 3 and 4  or, as shown in  FIGS. 1 and 2 , mating flanged elements. Clamp  113  clamps cover plate flange  101 , located above and valve mounting flange  112 , located below, together about swivel shoulder  111 . Swivel shoulder  111  engages with mounting flange shoulder  114 . While swivel shoulder  111  would not be necessary in order to be able to swivel the valve to any position over 360 degrees if the attachment device is two flanges clamped together as shown in  FIG. 1 , if, however, the attachment device  107  includes a bolt pattern, the assembly would only be able to be rotated to certain positions. A significant benefit of having valve mounting flange  112  as a distinct piece from valve body  10  as shown in  FIG. 1  is that it will allow one standard body of the valve to be mated with a variety of preexisting bolt and clamp patterns.  
      When the attachment device  107  is tightened, the upper margin  116  of the valve body  10  is moved into contact with the bottom of gasket  115  while the annular recess  117  of cover plate  100  is moved into contact with the top of gasket  115 , creating a seal between the cover plate  100  and the valve body  10 . For diaphragm change-out and other maintenance procedures, valve body  10  and the attached actuator device  5  may be quickly and easily disconnected from cover plate  100  by removing the attachment device  107 .  
      Valve body  10  may have a second inlet  160  entering into internal cavity  11  through a second inlet opening  161  in the side wall of valve body  10  as shown in  FIG. 1 . This additional inlet generally would be used to supply cleaning solutions, rinse water and steam to clean the valve in-situ between uses. Placing the second inlet in a side wall of valve body  10  as shown in  FIG. 1  may be simpler to do than in many other places on the valve, but the most effective location is likely to be near the top of the internal cavity  11 , radially from the diaphragm and offset to one side, preferably in an orientation that would direct inlet flow in a downward spiral pattern with the flow being oriented so as to flow directly into the drain passage opening  31 .  FIG. 2  illustrates an example of effective positioning of the second inlet  160 . Drain passage opening  31  is shown centrally placed at the bottom of internal cavity  11 . Drain passage opening  31  might be most effective if it was shifted to the side so as to capture more fully the second inlet flow.  
      Drain outlet  30 , which is in communication with drain passage opening  31  opens into drain passage  32 , which, in turn, leads to drain passage exit  33 . Drain passage exit  33  includes a drain connection device  34  for forming a connection to downstream piping so as to convey the material drained through the valve assembly away. By way of example, drain connection device  34  is shown here as a sanitary clamp connection but could be any suitable form of connection capable of conveying drained material. In the preferred embodiment shown, bottom wall  12  is shown declining to drain passage opening  31 . Although not a necessity, this arrangement would generally be considered a desirable one since the slope of bottom wall  12  and its smooth, uninterrupted transition across drain passage opening  31  into drain passage  32  combined with the declining orientation of the drain passage  32  would passively urge material from within the valve, thereby acting to keep it clean and free of potential contaminants. This feature is generally lacking in the background art and in equipment available today, the details of which will be discussed below.  
      A primary source of problems occurring in valves used as drain valves in sanitary applications relates to the seal arrangement made between the valve body and the valve operating rod. With valve designs in use today, a seal is formed between a second side of the bottom wall of the internal cavity with a sealing element, be it an O-ring or diaphragm. Because this seal is formed behind the second side of the bottom wall, the position of this portion is at the lowest point in the internal cavity, below even the opening to the drain outlet. As a consequence, drain valves being used today all tend to collect material in the basin formed about the seal. The thickness of the bottom wall, between the first, process side and the second, non-process side, dictates how readily material can be flushed out of the pooling area about the seal. Even in the best of situations this is still a concern to operators.  
      It is the purpose of the present invention to provide a new sealing device that will eliminate the well or crevice area found at the bottom of valves, thus removing a significant risk factor for process contamination.  
      In the place of the bore with a seal face on the second side of the bottom wall  12  of valve body  10  for mating with either an O-ring or diaphragm found in other valves, the present invention includes a central raised tubular structure or pedestal  50 . Shoulder  43  of diaphragm clamp sleeve  40  is inserted up into diaphragm shoulder recess  64 . A lower portion of diaphragm clamp sleeve  40  is inserted into pedestal central bore  51 . Furthermore, the diaphragm clamp sleeve  40  includes a central bore  41  through which a valve operating rod  130  passes. As diaphragm clamp sleeve  40  is pulled further down into pedestal central bore  51 , shoulder  43  pulls a bottom, process-side surface or shoulder  68  of diaphragm  60  down and into contact with top annular surface  53  of pedestal  50 . As the threads  142  of retainer nut  140  are further tightened onto clamp threads  42  of diaphragm clamp sleeve  40 , the upper face of retainer nut  140  is brought into contact with a second side  86  of bottom wall  12 , causing diaphragm clamp sleeve  40  to be pulled further down into pedestal central bore  51  and causing shoulder  43  to compress the shoulder  68  of diaphragm  60  against top annular surface  53  of pedestal  50 , forming inverted seal  56  with it. Inverted seal  56  and other seals like it that will be discussed below are all exposed seals that are easy to clean in-situ and are passively self-draining seals that tend to shed process material rather than collect them. The retainer nut  140  includes retainer nut flats  141  for engaging with a wrench to tighten the retainer nut  140 .  FIG. 1  depicts upper lip  69  and lower lip  70  on shoulder  68  interlocking with lip  44  on shoulder  43  and raised outer annular lip  52  on top annular surface  53 , respectively. These interlocking structures add to the stability of the seals formed but may not be necessary, depending on the physical and chemical process conditions that will be encountered. Also, while the mating surfaces of shoulder  68  of diaphragm  60 , of top annular surface  53  of pedestal  50  and shoulder  43  of diaphragm clamp sleeve are all shown as being generally horizontal, this need not be the case. While arrangements that are horizontal or angled so as to promote drainage to the outside diameter of the pedestal are preferred, arrangements having an angle down and toward the inside of pedestal  50  can also provide good results.  
      Diaphragm  60  may be formed as a one-piece unit with a threaded tip insert  81  as shown in  FIG. 1 . Diaphragm  60  also includes a flexing upper base shoulder  67 , neck  65 , and sealing tip  62 . The threads  132  on the tip of valve operating rod  130  may be threaded up into threads  87  in insert  81 . In order to assure that valve operating rod  130  does not unscrew from insert  81  during operation, when valve operating rod  130  is inserted through diaphragm clamp sleeve  40 , a pin  138  may be inserted partway through a hole  47  in the wall of diaphragm clamp sleeve  40  so that it extends into a longitudinal keyway  136  in the side of valve actuating rod  130 . Likewise, to keep diaphragm clamp sleeve  40  from rotating, a longitudinal keyway  45  is fitted with a pin  46  which extends out into a recess notch  48  cut into the second side  86  of bottom wall  12 . Pin  46  is fixed in notch  48  by pressure from below by the upper face of retainer nut  140 .  
      Valve operating rod  130  includes a long neck  121  that fits inside diaphragm neck  65 . At the base of long neck  121  is a diaphragm support shoulder  122  that mates with flexing upper base shoulder  67  of diaphragm  60 , providing it with support. Just below the diaphragm support shoulder  122  is an O-ring  134  and groove  135  that seals between valve operating rod  130  and the central bore  41  of diaphragm clamp sleeve  40 . The lower body  123  of valve operating rod  130  terminates in T-cap  137 . T-cap  137  fits into a T-slot  146  formed in handwheel  144 , which is equipped with threads  145  which mate with opposing bonnet threads  155  formed in bonnet  163 . The lower portion of handwheel  144  fits into a central bore  165  in handgrip  156  where it is pinned with a lock-pin  148  inserted in a bore  158  extending laterally through the side of handgrip  156  and into a similar bore  147  in handwheel  144 .  
      Handgrip  156  has a handle sleeve  157  that fits around the outside of bonnet neck  164  and seals against it with an O-ring and groove combination  159 . In  FIG. 1 , bonnet  163  has a base plate  151  with alignment lip  154  and bonnet recess  152  and is shown affixed to valve body  10  by bolts  149  inserted in bolt holes  153  formed in base plate  151  and threaded into valve body  10 . This method of attachment is simply one example of many different ways that could be used to attach the bonnet  163  to the valve body  10 .  
      When handgrip  156  is rotated, handwheel  144  is threaded up or down in bonnet  163 , pushing and pulling valve operating rod  130  and the attached sealing tip  62 , causing sealing tip  62  of diaphragm  60  to reversibly seal and unseal the valve.  
       FIG. 2  depicts the valve in an opened condition.  FIG. 2  also shows an alternative position of the second inlet  160  which offers benefits with regard to improved cleaning, rinsing and sterilizing over the position depicted in  FIG. 1 . The remaining elements in  FIG. 2  are the same as those in  FIG. 1  and have therefore not been further described.  
       FIG. 3  depicts one alternative diaphragm design offering a greater range of motion through the incorporation of a bellows  66  as an integral part of the diaphragm  60 . the embodiment of  FIG. 3  fails to include the second inlet  160  of  FIGS. 1 and 2 ; however, it should be understood that a second inlet  160  may be included, depending on the application. The remaining elements in  FIG. 3  are substantially the same as those in  FIGS. 1 and 2  and therefore have not been further described.  
       FIG. 4  depicts another arrangement of the inverted seal design of the present invention in which the diaphragm  60  is annular or frusto-conical and double-layered. The arrangement shows inner and outer diameter sealing arrangements in addition to depicting one method by which a 2-layer sealing cap  83  may also be secured over an insert  81 .  FIG. 4  also illustrates another attachment device  107  for connecting valve body  10  to cover plate  100 , as described previously, wherein a bolt  108  and threads  109  are used to secure the elements together.  
       FIG. 5  is a close-up of the sealing device of the valve  1  shown in  FIG. 4 . As can be clearly understood, the sealing cap  83  includes two layers. A first, outer layer  88  and a second, inner layer  89 . Furthermore, the diaphragm  60  includes two layers  94  and  95 .  
      Diaphragms used in the food, beverage and pharmaceutical industries are usually made of Buna-N (Butadiene/acrylotonil), EPDM (Ethylene/propylene/diene), VITON (Flurocarbon), Silicon (Medical grade silicon) or TEFLON (PTFE or Polytetraflouroethylene)  
      PTFE is frequently used where diaphragm purity or inertness are desired, like with many products that might be injected. The problem with PTFE is that it is fairly still, more like plastic than rubber and tends to cold flow, meaning that you might tighten it down snugly today but, over time and under pressure, it will buldge out to the sides and become loose again. That is why it is pretty common to put some type of layer of rubber (elastomeric) backing material behind it. That way the rubber material continues to press the TEFLON into the mating sealing surface even after it has begun cold-flowing under pressure. Actually, a seal made with PTFE without backing may stay water tight for a week or a month but with rubber backing it might continue to hold for years.  
      It should be noted that the embodiments of the present invention illustrated in  FIGS. 1-3  may also include two layer diaphragms and the embodiment of FIGS.  4  and  5  may be made with one layer of material for the sealing cap  83  and the diaphragm  60 , depending upon the particular application of the valve  1 .  
      By way of example, FIGS.  6 ( a ) to  6 ( e ) depict several other methods by which inverted sealing arrangements can be made.  
       FIG. 6 ( a ) illustrates another manner in which the concept of the inverted seal can be applied. The valve in this figure is similar to that in  FIG. 1 . The embodiment of  FIG. 6 ( a ) differs in that the diaphragm  60  does not include the neck  65  and shoulder  67  as shown in  FIG. 1  but, instead, includes only a shoulder  68  with the sealing tip  62 , supported from underneath by the shoulder  187  of the insert  81 , forming a reversible seal with the annular sealing surface  21  about the first inlet  20  (see  FIG. 1 ).  
      A further difference is that the shoulder  68  extends much further inward, toward the central axis of the valve actuating rod  130  where it forms a seal with the pedestal  50 . As a consequence, the pedestal  50  and diaphragm clamp sleeve  40  necessary to form the static seal between the bottom process side of the diaphragm  60  and the top process side of the pedestal  50 , would probably be narrower than shown in  FIG. 1  for the same size valve. This is because the flexing portion  59  of the diaphragm  60  is now formed in the shoulder  68 , rather than in the shoulder  67  as in  FIG. 1 . Also, if the valve were generally of the same dimensions as the one shown in  FIG. 1 , the pedestal  50  and the diaphragm clamp sleeve  40  would need to be longer in order that a newly positioned sealing surface  63  of the diaphragm  60  may be brought into contact with the sealing surface  21  about the first inlet  20 . Another difference illustrated in  FIG. 6 ( a ) would be the elimination of the shoulder  122  between the lower body and the neck  121  of the valve operating rod  130 . This structure, designed to support the flexing upper shoulder  67  of the diaphragm  60  from underneath, could be included as a shoulder  49  built into the pedestal  50 , similar to that seen in  FIG. 4 .  
       FIG. 6 ( a ) also depicts other differences from  FIG. 1 . The shoulder  187  of the insert  81  includes an undercut  181  where the diaphragm  60  thickness is made greater. This thickness or rib  182  serves to stabilize the diaphragm  60  and dampening the motion occurring along the shoulder  68 , inhibiting its transfer through the diaphragm  60  up to the sealing surface  63  of the diaphragm  60  where it reversibly seals with sealing surface  21  about the first inlet  20 . A further stabilizing diaphragm inclusion is the first ring  183  positioned in the diaphragm  60  near the outer rim of the insert  81 . Besides serving to dampen the transfer of motion caused by the flexing of the shoulder  68 , both the rib  182  and the first ring  183  tend to keep the diaphragm  60  from shifting in position relative to the insert  81 .  
       FIG. 6 ( a ) also includes a second ring  184  positioned within the diaphragm  60  about the center hole  72  of the diaphragm  60  and adjacent to where the process side of the diaphragm  60  forms a static seal with the first, upper, process side of the bottom wall  12  of the internal cavity  11 . In all of the other depictions of diaphragms provided in the present disclosure, the diaphragm  60  has no inclusions and, in order to stabilize the diaphragm  60  where it is desirable to form static seals with valve elements, lips have  69  and  70  have been shown constructed in the diaphragm  60  which interlock with opposing lips  44  and  52  in the mating valve elements. It is usually more expensive to include interlocking combinations. Accordingly, where possible and acceptable, it would be desirable to eliminate these lips, both in the structure of the diaphragm  60  and in the valve elements. An alternative approach which may sometimes be acceptable and, in some instances preferable, an internal stabilizing element may be used, here, shown as rings  183  and  184 . Other approaches include perforated washer insertions, cloth or wire mesh and many more items. If properly stabilized, the lips on both the diaphragm clamp sleeve  40  and the pedestal  50  could be eliminated, as shown in  FIG. 6 ( a ) in any of the embodiments of the present disclosure.  
      Sometimes these inclusions present manufacturing and assembly challenges. In this case, the diaphragm  60  could be molded around the threaded insert  81  with the diaphragm clamp sleeve  40  nested up into the annular cutout  185  shown. The rings  183  and  184  could be stabilized during the molding process from the insert  81  and the diaphragm clamp sleeve  40 .  
      Lastly, the outer margin of the shoulder  68  of the diaphragm in  FIG. 6 ( a ) comes to a relatively sharp edge, a structure not seen in other drawings herein. This is a drip lip  186 , designed to encourage materials running down the upper surface of the sealing tip  62  to drip off rather than cling to the underside of the diaphragm  60  and flow down over the seal and down the side of the pedestal  50 .  
       FIG. 6 ( b ) is the same as  FIG. 6 ( a ) with regard to peripheral structures of the valve (not shown).  FIG. 6 ( b ) is also similar to  6 ( a ) in that the flexing of the diaphragm  60  takes place on the shoulder  68  as illustrated by the flexing portion  59 . In  FIG. 6 ( b ) is shown retaining interlocking lip structures  187  and  188  formed in each of the two layers of the diaphragm  60  as well as in the mating valve elements shown.  FIG. 6 ( b ) includes a double-layered diaphragm  60  as do  FIGS. 4, 5 ,  6 ( c ),  6 ( d ) and  6 ( e ).  FIG. 6 ( b ) also depicts a pedestal shoulder  49  (described in the discussion about  FIG. 6 ( a ) above) which is positioned in much closer proximity to the shoulder  68  of the diaphragm  60 , more clearly illustrating how it would provide support from below when the sealing assembly is retracted, as it is shown here;  FIG. 6 ( a ) shows the assembly extended. Another difference between the assemblies shown in FIGS.  6 ( a ) and  6 ( b ) is that the diaphragm  60  in FIG. ( 6   a ) is closed above while the one in  FIG. 6 ( b ) is shown open. The purpose for showing this difference is to illustrate, again, that the diaphragm  60  may be made in a number of ways such as opened above but forming a seal with a cover attached to the valve operating rod or closed above and secured to an insert  81  which, in turn, can be affixed to the valve operating rod, so that, in both cases, the valve operating rod can move the assembly, reversibly bringing the sealing tip  62  in contact with the annular sealing surface  21  about the first inlet  20  to open and close the valve.  FIGS. 1-5 ,  6 ( c ),  6 ( d ),  6 ( e ) and  7  all depict some of the many different arrangements that may be made, all of which include a static seal being formed between a first, process side of the bottom wall  12  or a raised surface of the bottom wall  12  of the internal cavity  11  and a first, process side of the diaphragm  60 .  
      Continuing, the diaphragm  60  in  FIG. 6 ( b ) has a short upper shoulder  58  supported from beneath by a two-piece insert, the inner piece  171  of which rests against a lip or step  131  formed in the valve operating rod  130 . The short upper shoulder  58  forms the sealing surface  63  that mates with the sealing surface  21  about the first inlet  20 . The shape of the nested two-piece insert is designed so as to facilitate assembly of a semi-ridged diaphragm  60  onto a supporting insert structure. The outer nesting insert  172  which fits into the diaphragm recess can be sectioned vertically into pie sections to facilitate assembly. When the threaded cap  74  is tightened down onto the valve operating rod  130  after the two-piece nesting insert is in place, the assembly will tend to self-align while, at the same time, forming an upper process side seal with the short upper shoulder  58  of the diaphragm  60 . The sloping in the short upper shoulder  68  assures it will drain down and away from the sealing interface with the lip of the threaded cap  74 . The seal formed on the underside of the diaphragm  60  with the pedestal  50  is the same as in  FIG. 6 ( a ). The diaphragm  60  in  6 ( b ) also includes the rib  182  to dampen transfer of the flexing motion of the shoulder  68  of the diaphragm  60  as the valve is actuated as in  FIG. 6 ( a ).  
       FIG. 6 ( c ) combines the short upper shoulder  58  and long lower shoulder  68  seen in  FIG. 6 ( b ) but without the added rib  182  of  FIG. 6 ( b ). Instead, a separate sealing cap  83  is included, similar to that seen in  FIGS. 4 and 5 , but opened at the top as illustrated in  FIG. 6 ( b ). By placing threads  189  along the inside diameter of the uppermost insert  190 , a cap  74  can be formed in the end of the valve operating rod  130 . With the diaphragm cover in place on the uppermost insert  190 , it can be threaded up on the valve operating rod  130  threads until a tight seal is formed at the top. As in the case of  FIG. 6 ( b ) and elsewhere, a draining seal is achieved. The outer edge of the lower threaded insert  175  is inserted into the recess  191  under the short upper shoulder  58  of the lower flexing diaphragm  60  and a spacer  176  with opposing sealing surfaces designed to mate with the bottom sealing surface of the sealing cap  83  and the top sealing surface of the bottom flexing diaphragm  60  is place in position therebetween and the lower threaded insert  175  is threaded up into the uppermost insert  190 . Tightening the lower threaded insert  175  into the uppermost insert  190  compresses the elements and forms tight seals about the lower shoulder of the sealing cap  83  and the upper shoulder of the lower diaphragm  60 . The last seal, formed between the flexing diaphragm and the pedestal  50  and diaphragm clamp sleeve  40  is formed in the same fashion and elements as in  FIG. 6 ( b ).  
      One of the benefits of the embodiment of  FIG. 6 ( c ) is that the diaphragms and sealing caps used can be designed so they are relatively flat and open, making them easier and less expensive to make. Furthermore, this figure and  FIG. 6 ( d ), besides showing some of the many arrangements possible, demonstrates that the same diaphragm can be used to make many different arrangement and configurations. All four of the diaphragm and sealing cap pieces depicted in FIGS.  6 ( c ) and  6 ( d ) are identical. One practical benefit of such design arrangement is that only one type of replacement part needs to be stocked.  
      As mentioned above, the diaphragm and sealing cap elements pictured in  FIG. 6 ( d ) are identical to each other as well as to each of the ones pictured in  FIG. 6 ( c ). In order to form the seals for the sealing cap  83 , a set of inserts  177  and  178  with mating sealing faces and with threaded inside diameters are introduced. These may be threaded up onto the threads on the outside of the valve operating rod  130  and made to securely engage and form seals with the sealing faces of the sealing cap. The upper seal of the lower diaphragm  60  is formed with the bottom of the second insert  178  and the top of a third insert  176 , also threaded up on the valve operating rod  130  on its inside diameter threads. The lower seal of the diaphragm  60 , the diaphragm which will be perform the flexing in this case, is formed with the same structural elements and in the same manner as was the seal in  FIG. 1 . The third insert  176  provides the same supporting shoulder function as did the shoulder  122  formed as a part of the valve operating rod  130  in  FIG. 1 . Lastly, this third insert  176  is depicted with two sets of o-ring seals  195  and  196  to seal against the inside diameter  41  of the diaphragm clamp sleeve  40  while the counterpart sealing arrangement depicted in  FIG. 1  only showed one o-ring seal. It should be understood that one could, in all instances that appear in the present disclosure, include more than one o-ring-o-ring groove sealing combination if it were deemed desirable to do so.  
      All of the structures in  FIG. 6 ( e ) can be found within  FIG. 6 ( c ). Essentially,  FIG. 6 ( e ) combines both the upper and lower double-layer diaphragm elements into one diaphragm element. This element is open above and below, having seal-forming surfaces with lips located annularly about each opening. As in  FIG. 6 ( c ), once the insert  179  is placed within the recess of the diaphragm, it can be threaded up onto the threads near the tip of the valve operating rod. As the insert  179  is tightened onto these threads, the center upper annular seal surface with its lip are brought into tight contact with the opposing interlocking sealing surface and lip combination formed on the lower side of the valve operating rod  130  tip. Because the seal is formed with all the elements having externally declining surfaces, this sealing arrangement, used here and depicted in other figures, such as in FIGS.  6 ( c ) and  6 ( d ), drains and does not collect material. This sealing arrangement is the same as in  6 ( b ) but it is depicted formed out further on the upper shoulder and, instead of the insert being threaded up on the valve operating rod  130 , the tip is a separate piece with threads and is tightened down from above on the valve operating rod  130 . The manner in which the lower shoulder seal is formed with the pedestal  50  and the diaphragm clamp sleeve  40  in  6 ( e ) is the same as in all of the other configurations pictured here.  FIG. 6 ( e ) also depicts a diaphragm  60  with a rib  182  formed in a recess  181  in the insert  179 . What makes this diaphragm arrangement special is its compactness and the fact that it would lend itself to manufacturing with the insert  179  in place, particularly if the application allowed the diaphragm to be manufactured without the lips which are needed sometimes to help assure the stability of the seal.  
       FIG. 7  illustrates a diaphragm tulip valve. Tulip or kettle valves available today still include a dynamic O-ring seal placed at the bottom of the internal valve cavity, behind a first surface of the bottom wall of that cavity as they have for years. This design approach, although simple, mechanically dependable and inexpensive to manufacture, results in the formation of a collection well or sump just above the dynamic O-ring seal formed with the valve operating rod or stem, and is a site where material collects and adheres and, later, between process batches, becomes very difficult to remove in-situ without manual intervention. Concerns about batch-to-batch contamination are further enhanced with design by the fact that material can be carried down past the O-ring seal where it will be sheltered from cleaning and sterilizing procedures only to be reintroduced some time later, resulting in contamination of that batch. In spite of these problems, tulip or kettle valves are still used quite widely today in processes that are robust and resistant to the effects associated with carryover contamination, such as in many food, beverage and toiletry products as well as in chemical manufacturing. They are usually not found in pharmaceutical manufacturing or other industries where aseptic processing is being carried out because of major concerns about contamination risks associated with the difficulty of seal in-situ cleaning and resterilizing.  
      By applying the novel seal design approach discussed earlier in both the diaphragm and O-ring configurations, depending on the specific process needs of the user, the problems associated with tulip or kettle valves can be largely overcome, allowing these very cost effective designs to be used in a greater number of more demanding aseptic processing applications as well as providing better, more reliable service in current applications.  
      In the particular case of applying inverted seal diaphragm technology, a pedestal  50  is extended up from the first side of the bottom wall  12  through the first inlet  20  and the lip  71  on the inner diameter of the flexing diaphragm  60  is captured by inserting the diaphragm clamping sleeve  40  through the center hole  72  in diaphragm  60  and then inserting it into the central bore  51  of pedestal  50 . As described previously, the inner diameter (which may or may not have a lip  71 ) of the diaphragm  60  is captured between the shoulder  43  of the diaphragm clamping sleeve  40  and the top annular surface  53  of pedestal  50  as retainer nut  140  ( FIG. 1 ) or other tightening devices are applied at the distal end of the diaphragm clamping sleeve  40 . If the seal had the diaphragm formed as an integrated part, then, by definition the outer diameter lip of the diaphragm would be an integrated part of the sealing tip and it would not be necessary to further secure it to the sealing tip. If, however, the diaphragm is not formed as an integrated part of the sealing tip, it would need to be captured on the sealing tip as well as illustrated in  FIG. 7 . Accordingly, in  FIG. 7 , a threaded collar insert  73  is formed as a part of the diaphragm  60  or is inserted into a mating space within the diaphragm  60  near its outer rim. The further radially this threaded collar can be installed allows greater flexing diaphragm cone radiuses to be used, thus, allowing greater ranges of motion to be achieved. With the end of valve operating rod  130  partially inserted into the central bore  41  of diaphragm clamping sleeve  40 , the mating threads  76  of cap  74  affixed on the end of valve operating rod  130  can be mated and tightened onto the threads  75  of collar insert  73 . As these threads are tightened, and outer annular surface  77  of the diaphragm  60  is brought into sealing contact with an opposing sealing surface  78  on cap  74 , thereby creating an outer seal, which, in combination with the inner seal, seals off and isolates the process from the internal mechanical elements of valve and the surrounding outside environment. In so doing, a seal arrangement is created in a tulip or kettle valve, resulting in a valve with all of the benefits of tulip or kettle valves and the additional benefit of now being a sanitary diaphragm design which can effectively be cleaned and sterilized in-situ and which would now be acceptable for use in aseptic processing applications as well as in all of the traditional applications it has been used for in the past.  
      It should be noted that the all of the above-described diaphragm arrangements in FIGS.  6 ( a )- 6 ( c ) and  6 ( e ) may be constructed to seal from above the surface  102  as in  FIG. 7 . This would provide the same advantages to tulip valve constructions mentioned above, while additionally isolating the process from valve elements and the surrounding outside environment.  
       FIG. 8  is an O-ring seal tulip valve. In the food and beverage industry, many operators continue to used the traditional O-ring-based tulip and kettle valve designs, as described above, because they are, relatively speaking, very inexpensive to install and maintain. Furthermore, for most food and beverage applications where the process is fairly robust and resistant to contamination episodes, the traditional valve designs have provided long periods of service with minimal down time for maintenance. Nonetheless, there have been several incidents in the last few years where these types of valves have been implicated as the source of food and beverage contamination episodes that resulted in serious illness to people. Because these valves are frequently used in process applications that do not lend themselves to the introduction of diaphragm valves, either for physical, chemical or economic reasons, it is still of value to try to improve upon their design so as to further reduce the risk of process contamination events in the future.  
       FIG. 8  is an example illustrating how tulip and kettle valves can be modified and their sealing systems rearranged using inverted seal technology to make them easier to clean and sterilize in-situ, to reduce their threat as a potential source of process contaminants, including threatening microbes. The valve body  10  has a pedestal  50  extending up from the bottom wall  12  of the internal valve cavity  11 . Valve operating rod  130  is fitted with or is formed with a cap  74  as in  FIG. 7 . The cap may itself be capable of forming a seal with the inlet annular sealing surface  21  about the first inlet  20  or it may have integrated into it a sealing element (not shown) or the sealing surface  21  with which it will mate may have a sealing element  23  integrated therewith, as can be seen in  FIG. 8 . In any case, a seal may be reversibly formed with a mating annular sealing surface  84  about the first inlet  20  on either the upper surface  102  or the lower surface or roof  13  of the cover plate  100  about first inlet  20 . In the example illustrated in  FIG. 8 , the valve operating rod would extend through first inlet  20  and the affixed cap  74  would be raised above the first inlet  20  in the opened condition and be retracted so as to bring the sealing surface  84  of the cap  74 , in this instance located on its lower margin, into sealing contact with an upper annular sealing surface  21  located along surface  102  of cover plate  100  and sealing element  23  into sealing contact with each other. In the second case (see  FIG. 9 ), where cap  74  is positioned within the internal cavity  11  of the valve  1 , extending the valve operating rod  130  would bring the sealing surface  84 , now located on an upper margin of the cap  74 , into sealing contact with annular sealing surface  21  located on roof  13  and sealing element  23  about first inlet  20 . In both cases ( FIG. 8  and  FIG. 9 ), a seal sleeve  80  coaxial with the valve operating rod  130  extends down from the bottom of cap  74  formed or affixed on the end of valve operating rod  130  and mates, along its inside diameter wall  79 , with an outside diameter wall  54  of pedestal  50 . An O-ring groove  91  is cut into the inside diameter wall  79  of seal sleeve  80  just above a lower margin  92  thereof. An O-ring  93  installed in O-ring groove  91  forms a sliding sealing arrangement with the outside diameter wall  54  of pedestal  50 . The benefits of this sealing device is that it is inverted from that found in traditional tulip, kettle, plug, ball and other valve designs, thereby creating a passively draining sealing arrangement that will not tend to collect material in pooling fashion as is found with the prior art. Additionally, an access to the non-process side of the seal can be achieved by boring holes in the valve operating rod as illustrated in  FIG. 7  or, as illustrated in  FIGS. 8 and 9 , by constructing an upper portion XXX of pedestal  50  with an inside diameter larger than an outside diameter of valve operating rod  130 , a significantly sized space  55  may be created within the pedestal. Referring to  FIGS. 8 and 9 , feed and drain passages  14  and  15  can be bored in bottom wall  12  of valve body  10  that will be large enough for cleaning agents, rinses and steam can be fed at high flow rates into the cavity to assure highly effective in-situ cleaning, rinsing and sterilizing of the non-process side of sliding sealing arrangement to be accomplished without clogging. The process side of the valve can be cleaned by including a second inlet opening directly into the valve body internal cavity  11 , as illustrated in  FIGS. 1 and 2 , through which cleaning agents, rinses and steam directly can be supplied. These will be drained from the valve internal cavity by flowing down and out the drain outlet  30 . This design has the special benefit of a seal design that can be very effectively cleaned from both the process and no-process sides simultaneously. Because it is best to clean and sterilize an O-ring seal when the mating surfaces are exposed and accessible to the cleaning, rinsing and sterilizing agents, the valve illustrated in  FIG. 8  and described above could most effectively be cleaned and sterilized when it is in the open (extended) position. The valve illustrated in  FIG. 9  and also described above, could best be cleaned while in the closed position.  
      It should be noted that, once the concept of inverted seal technology is understood, many other variations on the concept will become apparent to someone knowledgeable in the art.  
      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.