Patent Publication Number: US-2005133729-A1

Title: Apparatus and method for fabricating a reconstitution assembly

Description:
TECHNICAL FIELD  
      The present invention relates generally to drug reconstitution. More specifically, the present invention relates to an apparatus for assembling a reconstitution assembly wherein containers are sterilely connected to a drug reconstitution device.  
     BACKGROUND OF THE INVENTION  
      Reconstitution devices, as well as the apparatuses that assemble reconstitution devices are known in the art. Reconstitution devices are generally used to mix a drug with a diluent to form a reconstituted drug that is delivered to a patient. Certain reconstitution devices are shown, for example in U.S. Pat. Nos. 6,022,339 and 6,071,270 to Fowles et al.  
      While reconstitution devices and their associated fabricating apparatuses according to the prior art provide a number of advantageous features, they nevertheless have certain limitations. The present invention seeks to overcome certain of these limitations and other drawbacks of the prior art, and to provide new features not heretofore available.  
     SUMMARY OF THE INVENTION  
      The present invention provides an apparatus for assembling a reconstitution assembly wherein a first container and a second container are connected to a reconstitution device to form the reconstitution assembly.  
      According to a first aspect of the invention, the reconstitution assembly generally comprises a first container, a second container and a reconstitution device. The first container is generally a diluent container and can be, for example, a flexible diluent bag or syringe. The second container is generally a drug container and can be, for example, a drug vial containing a drug in powdered, lyophilized or liquid form. The diluent container and drug vial are sterilely connected to the reconstitution device. The reconstitution device has a piercing member that is hermetically sealed from an outside environment. The reconstitution device has an inactivated position and an activated position. When the reconstitution device is moved from the inactivated position to the activated position, the piercing member enters the first container and the second container to establish fluid communication between the containers. In the activated position, fluid from the diluent container passes through the piercing member and into the drug vial to reconstitute the drug. The reconstituted drug is transferred into the diluent container wherein it can be delivered to a patient from the diluent container.  
      According to a further aspect of the invention, an apparatus for the sterile connecting of a container and a reconstitution device includes a sterilization source. While the sterilization source can take many different forms, in one preferred embodiment, the sterilization source is capable of emitting radiation to define a sterilizing field. The apparatus further includes a connecting mechanism positioned proximate the sterilization source. The connecting mechanism is configured to hold the container and reconstitution device in a sterilizing field. The connecting mechanism includes a movable member configured to provide relative motion between the container and reconstitution device to connect the container to the reconstitution device in the sterilizing field.  
      According to another aspect of the present invention, an apparatus for the sterile connecting of a container and a reconstitution device includes a low energy electron sterilization source that provides an energy within a range of from about 60 to about 150 KeV to define a sterilizing field. The apparatus further includes a connecting mechanism positioned proximate the sterilization source. The connecting mechanism is configured to hold the container and reconstitution device in a sterilizing field. The connecting mechanism includes a movable member configured to provide relative motion between the container and reconstitution device to connect the container to the reconstitution device in the sterilizing field.  
      According to another aspect of the present invention, an apparatus for the sterile connecting of a container and a reconstitution device includes a first electron sterilization source positioned generally opposite a second electron sterilization source. A sterilizing field from the first electron sterilization source overlaps a sterilizing field from the second electron sterilization source radiation to define a concentrated field. The apparatus further includes a connecting mechanism positioned proximate the sterilization sources. The connecting mechanism is configured to hold the container and reconstitution device in the concentrated field. The connecting mechanism includes a movable member configured to move the reconstitution device into connection with the vial in the concentrated field. A housing is positioned around the sterilization sources and the connecting mechanism.  
      According to another aspect of the present invention, an apparatus for the sterile connecting of a vial and a drug reconstitution device includes a vial pallet. A device loader is configured for loading a reconstitution device onto the vial pallet. A container loader is configured for loading a vial onto the vial pallet. The apparatus includes a first sterilization booth for the sterile connecting of the reconstitution device and vial. A vial pallet conveyor conveys the vial pallet between the device loader, the container loader, and the first sterilization booth.  
      According to another aspect of the present invention, an apparatus for the sterile connecting of a container and a drug reconstitution device includes a vial pallet. A device loader is configured for loading a reconstitution device onto the vial pallet. A container loader is configured for loading a vial onto the vial pallet. The apparatus includes a first sterilization booth for the sterile connecting of the reconstitution device and vial. A vial pallet conveyor conveys the vial pallet between the device loader, the container loader, and the first sterilization booth. The apparatus also includes a bag pallet. In addition, a device and vial subassembly loader is provided for loading a device and container subassembly onto the bag pallet. A bag loader is configured to load a bag onto the bag pallet. A second sterilization booth is configured for the sterile connecting of the device and container subassembly and the bag. A bag pallet conveyor conveys the bag pallet between the device and vial subassembly loader, the bag loader, and the second sterilization booth.  
      According to another aspect of the present invention, a method for the sterile connecting of a container and a drug reconstitution device includes the steps of providing a container, a drug reconstitution device and a positioning assembly. The container and the drug reconstitution device are positioned in the positioning assembly. The positioning assembly is conveyed to a connection area. A sterilizing field is created within the connection area. The container is connected to the drug reconstitution device within the sterilizing field.  
      Other features and advantages of the invention will become apparent from the following description taken in conjunction with the following drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a perspective view of a reconstitution assembly showing a reconstitution device connected to a first container and a second container according to one embodiment of the present invention;  
       FIG. 2  is an exploded view of the reconstitution assembly of  FIG. 1 ;  
       FIG. 2A  is a partial cross-sectional view of the reconstitution assembly of the present invention of  FIG. 1  with only a portion of the first container shown;  
       FIG. 3  is a schematic plan view of a system for connecting and assembling the reconstitution assembly according to one embodiment of the present invention;  
       FIG. 4  is a front perspective view of a positioning assembly for use in a connecting system according to one embodiment of the present invention;  
       FIG. 5  is a front elevation view of the positioning assembly of  FIG. 4 , the assembly having a portion cut away;  
       FIG. 6  is a side elevation view of the positioning assembly in an unstacked loading position according to one embodiment of the present invention;  
       FIG. 7  is a partially cut away side elevation view of a container holder support of the positioning assembly according to one embodiment of the present invention;  
       FIG. 8  is another partially cut away side elevation view of the container holder support of  FIG. 7 ;  
       FIG. 9  is a side elevation view of the positioning assembly having a reconstitution device and drug vial loaded therein, the positioning assembly shown in an unstacked loading position according to one embodiment of the present invention;  
       FIG. 10  is a side elevation view of the positioning assembly of  FIG. 9 , the positioning assembly shown in a stacked connecting position;  
       FIG. 11  is a bottom view of the container holder support of the positioning assembly;  
       FIG. 12  is a partially cut away front elevation view of the container holder support of the positioning assembly;  
       FIG. 13  is a cross-sectional view of the container holder support of the positioning assembly taken along lines  13 - 13  of  FIG. 11 ;  
       FIG. 14  is a cross-sectional view of the container holder support of the positioning assembly taken along line  14 - 14  of  FIG. 11 ;  
       FIG. 15  is a top view of a reconstitution device receiver according to one embodiment of the present invention;  
       FIG. 16  is a side view of the reconstitution device receiver of  FIG. 15 ;  
       FIG. 17  is a top view of rotary dial-index table according to one embodiment of the present invention;  
       FIG. 18  is a side elevation view of the rotary dial-index table of  FIG. 17  as viewed from lines  18 - 18  in  FIG. 17 ;  
       FIG. 19  is a partial perspective view of a reconstitution device transfer robot according to one embodiment of the present invention, shown transferring reconstitution devices onto the positioning assembly positioned on a conveyor;  
       FIG. 20  is a top view of a reconstitution device presentation nest according to one embodiment of the present invention;  
       FIG. 21  is a top view of the presentation nest of  FIG. 20 , the nest shown in a second position;  
       FIG. 22  is a top view of the presentation nest of  FIG. 20 , the nest shown in a third position;  
       FIG. 23  is a top view of a first positioning assembly being loaded with a reconstitution device according to one embodiment of the present invention;  
       FIG. 24  is a plan view of a container loader module according to one embodiment of the present invention;  
       FIG. 24A  is a plan view of a container loader module according to another embodiment of the present invention;  
       FIG. 25  is a perspective view of a portion of a container loader module according to one embodiment of the present invention;  
       FIG. 26  is a side view of a portion of a container loader module according to one embodiment of the present invention;  
       FIG. 26A  is a side view of a portion of a container loader module according to one embodiment of the present invention;  
       FIG. 27  is a side elevation view of an uncap mechanism assembly according to one embodiment of the present invention;  
       FIG. 28  is a side elevation view of a pallet load robot according to one embodiment of the present invention;  
       FIG. 29  is a front view of a pallet load robot according to one embodiment of the present invention;  
       FIG. 30  is a cross-sectional view of an end of arm tooling for the pallet load robot of  FIG. 29  according to one embodiment of the present invention;  
       FIG. 31  is a cross-sectional view of a suction cup of the end of arm tooling of  FIG. 30 ;  
       FIG. 32  is a side elevation view of a pallet lift in a first position according to one embodiment of the present invention;  
       FIG. 33  is a partially cut away side view of the pallet lift of  FIG. 32  in a second position;  
       FIG. 34  is a side elevation view of a vial holder placement module according to one embodiment of the present invention;  
       FIG. 35  is a side view of a sterilization chamber according to one embodiment of the present invention;  
       FIG. 35A  is a side view of the sterilization chamber of  FIG. 35  in a connecting position;  
       FIG. 36  is a front cross-sectional view of one embodiment of a sterilization booth of the present invention;  
       FIG. 37  is a side cross-sectional view of the sterilization booth of  FIG. 36 ;  
       FIG. 38  is a top cross-sectional view of the sterilization booth of  FIG. 36 ;  
       FIG. 39  is a side elevation view of a vial holder removal module according to one embodiment of the present invention;  
       FIG. 40  is a side view of a loaded positioning assembly after connection in an unstacked loading position;  
       FIG. 41  is a partial perspective view of a depalletizing device and vial station according to one embodiment of the present invention;  
       FIG. 42  is another partial perspective view of the depalletizing device and vial station of  FIG. 41 ;  
       FIG. 43  is another partial perspective view of the depalletizing device and vial station of  FIG. 41 ;  
       FIG. 44  is a top view of the depalletizing device and vial station of  FIG. 41 ;  
       FIG. 45  is a perspective view of second positioning assembly according to one embodiment of the present invention;  
       FIG. 46  is a partial perspective view of the second positioning assembly of  FIG. 45 ;  
       FIG. 47  is top view of a device gripper of the second positioning assembly according to one embodiment of the present invention;  
       FIG. 48  is a top view of the device gripper of  FIG. 47 , the device gripper shown in an opened position;  
       FIG. 49  is front elevation view of the second positioning assembly according to one embodiment of the present invention;  
       FIG. 50  is a side elevation view of the second positioning assembly of  FIG. 49 ;  
       FIG. 51  is a plan view of a palletizing device and vial sub-assembly according to one embodiment of the present invention;  
       FIG. 52  is a side elevation view of a pallet release mechanism according to one embodiment of the present invention;  
       FIG. 53  is a plan view of a nozzle blow off station according to one embodiment of the present invention;  
       FIG. 54  is a partial side view of the nozzle blow off station of  FIG. 53 ;  
       FIG. 55  is a partial side view of a second sterilization chamber according to one embodiment of the present invention;  
       FIG. 56  is a partial side view of the second sterilization chamber of  FIG. 55 ;  
       FIG. 57  is a front cross-sectional view of the second sterilization chamber of  FIG. 55 ;  
       FIG. 58  is a partial front cross-sectional view of the second sterilization chamber of  FIG. 55 ;  
       FIG. 59  is a partial side view of a depalletizing reconstitution device assembly according to one embodiment of the present invention;  
       FIG. 60  is a side view of the depalletizing reconstitution device assembly of  FIG. 59 ;  
      FIGS.  61 A-C are schematic top views of a sterilization booth according to one embodiment of the present invention;  
       FIG. 62  is a schematic side view of sterilizing fields according to one embodiment of the present invention;  
       FIG. 63  is a schematic side view of sterilizing fields according to another embodiment of the present invention;  
       FIG. 64  is a schematic side view of sterilizing fields according to another embodiment of the present invention;  
       FIG. 65  is a perspective view of another embodiment of a reconstitution assembly according to the present invention; and  
       FIG. 66  is a perspective view of a locking device for use in conjunction with the reconstitution assembly shown in  FIG. 65 .  
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      While the invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail preferred embodiments of the invention. It is to be understood that the present disclosure is to be considered as an exemplification of the principles of the invention. This disclosure is not intended to limit the broad aspect of the invention to the illustrated embodiments.  
      The present invention provides an apparatus for assembling or fabricating a reconstitution assembly. According to one embodiment of the invention shown in  FIG. 1 , the reconstitution assembly is generally designated with the reference numeral  1 . The reconstitution assembly  1  generally includes a reconstitution device  10 , a first container  12 , and a second container  14 . In other embodiments, it may be desired to only attach a single container to a reconstitution device to form a reconstitution assembly. For example, an alternate reconstitution assembly  1  may comprise the reconstitution device  10  attached only to the first container  12 . Another alternate reconstitution assembly may comprise the reconstitution device  10  attached only to the second container  14 .  
      The reconstitution device  10  provides a connector device that is used to mix two substances within the first and second containers  12 , 14 . More particularly, the reconstitution device  10  reconstitutes a drug with a diluent. To accomplish the reconstitution of the drug, the device  10  is attached to the first container  12 , commonly a flexible bag or a syringe, containing a diluent, and is attached to the second container  14 , commonly a vial containing a drug, such as a pharmaceutical agent or cosmetic agent to be reconstituted. The device  10  provides fluid communication between the two containers through a hermetically sealed piercing member so that the drug may be reconstituted, and delivered to a patient. What is meant by hermetically sealed is that the portions of the piercing member that contact the fluid and that pierce the closures of the two containers  12 , 14  are sealed from the outside environment.  
      While the diluent will be a liquid, the beneficial agent may be either a powder or a lyophilized drug to be dissolved or a liquid drug to be reduced in concentration. The device  10  provides the benefit of allowing medical personnel to selectively attach a vial of their choice to the device  10 . Thus, hospitals and pharmacies do not have to stock pre-packaged drug vial and connector assemblies. Further, the device  10  of the present invention allows for docking a vial  14  to the connector  10  without breaching the hermetic seal of a piercing member associated with the connector  10  and without piercing the closure of the vial  14 . Thus, the vial  14  may be pre-docked to the device  10  of the present invention for essentially the full period the drug is active. Further, the device  10  can be activated by applying a force directly to the connector  10  without necessarily contacting sidewalls of the first and second containers  12 , 14 .  
      Referring to  FIGS. 1, 2  and  2 A, the first container  12  is typically a flexible bag or flexible diluent container, and is used to contain solutions for a patient to be received intravenously. Flexible containers are typically constructed from two sheets of a polymeric material forming sidewalls that are attached at their outer periphery to define a fluid tight chamber therebetween. The flexible containers can be made from a variety of materials. At one point on the periphery of the container  12 , a tubular port  16  is inserted between the sidewalls to provide access to the fluid chamber. The tubular port  16  could be considered to include a port adapter assembly  30  having a flange. A second port  18  is shown for allowing access by a fluid administration set to deliver the reconstituted drug to a patient. However, the first container  12  can be any type of container, including, for example, a syringe barrel, suitable for containing a liquid to be used to reconstitute a drug.  
      As further shown in  FIGS. 1, 2  and  2 A, the second container  14 , which contains a drug to be reconstituted, is a vial. The vial  14  is typically a glass or plastic container with a closure member. The closure member may include a rubber stopper  20  and may also have a crimp ring  22 . The rubber stopper  20  is inserted in an opening of the vial  14 . The rubber stopper  20  is held in place by the crimp ring  22  ( FIG. 2A ), typically made of soft metal such as aluminum, that is crimped around the stopper  20  and the neck of the vial  14  to fixedly attach the stopper  20  to the vial  14 . The crimp ring  22  has an aperture to define a target site on the rubber stopper  20 . The device  10  can preferably be adapted to accept vials of any size, particularly 20 mm and 13 mm vials. Additionally, the second container  14  can be any container that is adapted to accommodate drugs that require reconstitution.  
      The connector  10 , as stated above, is configured to connect to both the flexible bag  12  and the vial  14  and place the contents of the flexible bag  12  and the vial  14  into fluid communication with one another. As further shown in  FIGS. 1, 2  and  2 A, the connector  10  generally comprises a sleeve assembly  24 , a piercing assembly  26 , a gripper assembly  28  and a sleeve connector port  17 . The sleeve assembly  24  generally has a first sleeve  32  and a second sleeve  34 . In one preferred form of the invention, the second sleeve  34  is integral with the gripper assembly  28 . The gripper assembly  28  and one portion of the sleeve assembly  24  (e.g., the second sleeve  34 ), are collectively configured for axial movement with respect to another portion of the sleeve assembly  24  from an inactivated position to an activated position. What is meant by the inactivated position is that the containers  12 , 14  are not in fluid communication with each other wherein the connector  10  has not been activated. What is meant by the activated position is that the containers  12 , 14  are placed in fluid communication with each other wherein the piercing assembly pierces the closures of the first and second containers  12 , 14 . What is meant by the deactivated position, or post reconstitution position, is the first container  12  and the second container  14  are not in fluid communication and have been moved from the activated position to the deactivated position. The structure and operation of the reconstitution device  10  is further described in U.S. patent application Ser. No. ______, (Attorney Docket No. DDR-5392 A1 (1417B P 784)), filed concurrently herewith, which is incorporated herein by reference and made a part hereof. It is understood that the assembly and fabricating apparatus of the present invention can be used with a variety of different reconstitution devices and containers as desired.  
      The apparatus that assembles the reconstitution assembly  1  will now be described.  
      Structure/Apparatus  
       FIGS. 3-64  generally disclose a reconstitution assembly apparatus or connection system, generally referred to with the reference numeral  21 , that fabricates the reconstitution assembly  1  shown in  FIG. 1 . As shown in  FIG. 3 , the reconstitution assembly apparatus  21  is a multi-station assembly and generally includes a first section, or first cell  23 , generally referred to as a vial/device connection system  23 , and a second section, or second cell  25 , generally referred to as a bag/device subassembly connection system  25 .  
      The apparatus  21  is generally designed to provide two connections, preferably in a sterile manner. One connection is between the first container  12  and the reconstitution device  10 , and one connection is between the second container  14  and the reconstitution device  10 . However, in other embodiments, only one sterile connection may be desired. In those instances, one section of the system may be removed or not utilized, leaving only the first cell  23  or second cell  25 . The entire reconstitution assembly apparatus  21 , including both cells  23 ,  25 , will now be described with the understanding that parts of the system could be modified or removed without departing from the spirit of the invention as set forth in the appended claims.  
      First Cell: Vial/Device Connection System  23   
      The first cell  23  of the apparatus  21  generally serves to sterilely connect the second container  14  to the reconstitution device  10 . The connection of the second container  14  to the reconstitution device  10  is preferably an automated process wherein the reconstitution device  10  and second container  14  are sterilely joined without the direct contact of human operators with the reconstitution device  10  or second container  14 .  
      The first cell  23  generally comprises a positioning assembly  27 , a vial pallet transport assembly  90 , a device loader module  94 , a container loader module  154 , a vial holder placement module  260 , a vial/device sterilization booth  270 , a vial holder removal module  340 , a depalletize device/vial module  350 , and a shrinkband applicator  360 . Each of these components is discussed in further detail below.  
      Positioning Assembly  27  (Vial Pallet)  
      The positioning assembly in this instance is a vial pallet  27 , and one preferred embodiment is shown in  FIGS. 4-14 . As described in greater detail below, the vial pallet  27  is conveyed by the transport assembly  90  ( FIG. 3 ) to various locations in the first cell  23  and ultimately positions the vial  14  and the reconstitution device  10  such that they can be connected within a sterilizing field within the vial/device sterilization booth  270  ( FIG. 3 ). The vial pallet  27  acts as a transportable platform for holding and positioning the reconstitution device  10  and vial  14  for sterile connection. As shown in  FIG. 4 , the vial pallet  27  generally includes a base  29 , a reconstitution device holder  31 , and a container holder  54 , which is a vial holder in this embodiment.  
      The base  29  generally includes a plate  29   a  having a flat top surface upon which the other component parts of the vial pallet  27  are supported. The base  29  generally includes container holder supports  50  as shown in  FIG. 6 . The container holder supports  50  are shown in detail in  FIGS. 7 and 8 . The container holder supports  50  are generally rectangular and preferably include positioning pins  52  on a top surface for receiving the vial holder  54 . Preferably, the vial pallet  27  includes three container holder supports  50 , which are equally spaced, and support the vial holder  54 . The container holder supports  50  preferably include an internal slide  56 . The slide  56  generally includes a spring  58 . The spring  58  may become compressed when the slide  56  is raised as shown in  FIG. 8 . The spring  58  generally provides a biasing force to move the slide  56  back towards the pallet base  29  as shown in  FIG. 7 . The base  29  generally has an opening such that the slide  56  may be pushed upward through the opening in the base  29 .  
      As shown in  FIG. 4 , the reconstitution device holder  31  generally includes a support frame  33  and a device holder subassembly  35 . In a preferred embodiment, a plurality of device holder subassemblies  35  are included, generally four subassemblies  35 . The support frame  33  generally includes top holder supports  36  and a guide block  38 . The guide block  38  generally extends between the top holder supports  36 , and is generally secured to the top holder supports  36  by screws or other securing means. The top holder supports  36  preferably extend vertically beyond the guide block  38  and terminate in an upper surface having locating pins  40 . The guide block  38  generally provides a guide for positioning the device holder subassemblies  35 , and has openings in which the device holder subassemblies  35  are positioned.  
       FIG. 5  shows a cut-away view of the vial pallet  27 , including the device holder subassemblies  35 . Each of the device holder subassemblies  35  generally includes an external sleeve  42 . The external sleeves  42  generally extend from the base  29  through the guide block  38 , and protect the inner components of the device holder subassemblies  35 . The external sleeves  42  are preferably hollow cylindrical columns. Inside each of the external sleeves  42  is generally a spring  44 . The external sleeves  42  are generally secured to the base by spring retainers  46 . The spring retainers  46  preferably extend through the base  29 , into the external sleeves  42  and secure one end of each spring  44 . The other end of each spring  44  is generally secured to a device nest  48 . The device nest  48  is positioned in the external sleeve  42 . The device nests  48  are generally biased in the direction of the base  29  by the springs  44 . The device nests  48  preferably have a shape complementary to the shape of an exterior surface of the reconstitution device  10 , allowing the reconstitution device  12  to securely rest within the device nests  48 .  
      The container/vial holder  54  is generally a rectangular box having an open top. The vial holder  54  is preferably configured to hold four vials  14 . As shown in  FIG. 4 , it preferably includes a housing  59  and a vial clamping mechanism  75 . The vial holder  54  may generally be placed onto the vial pallet  27  in an unstacked loading position as shown in  FIGS. 6 and 9 , or in a stacked connecting position as shown in  FIG. 10 . When the vial holder  54  is loaded and in the connecting position, the reconstitution devices  10  and vials  14  are preferably coaxially positioned.  
      As shown in  FIGS. 4 and 11 , the housing  59  of the vial holder  54  generally includes end plates  60 . The end plates  60  are generally secured to first and second side plates  64 . A bottom plate  66 , as shown in  FIG. 11 , is secured to the end plates  60  and side plates  64  to form a rectangular box having one open side at its top. As further shown in  FIG. 11 , the bottom plate  66  generally includes four device openings  68 . The bottom of the vial holder  54  further includes pin holes  70  for receiving the positioning pins  40  of the reconstitution device holder  31  ( FIG. 4 ) or the positioning pins  52  of the container holder supports  50  ( FIG. 6 ). Additional access slots  72  are preferably also formed in the bottom plate  66 . Each of the end, side and bottom plates is generally formed of metal, such as steel or lead, and has sufficient thickness to give the vial holder  54  strength and to act as a radiation shield for the vial  14  when it is positioned in the vial holder  54 .  
      In use, vials  14  positioned within the housing  59  of the vial holder  54  are preferably shielded from undesired exposure to radiation, or other sterilizing effects, used to sterilize the connection formed between the vials  14  and reconstitution devices  10 . It is preferable to shield the vials  14  from unwanted exposure to sterilizing effects in order to preserve the efficacy of drugs typically stored within the vials  14 . In the preferred embodiment, the housing  59  of the vial holder  54  minimizes the exposure of the vials  14  to radiation from a low energy e-beam.  
      As further shown in  FIG. 4 , the vial clamping mechanism  75  of the vial holder  54  is configured to hold up to four vials  14 . The vial clamping mechanism  75  generally includes clamp pads  76  which are secured to clamp plates  78 . The clamp plates  78  are biased towards one another by springs  80 , as shown in  FIG. 14 , such that the clamp pads  76  may secure a vial  14 . Dowels  82  run through the clamp plates  78  between the side plates  64  of the vial holder  54 . As shown in  FIG. 13 , pins  87  extend from the ends of each of the clamp plates  78 .  
      As shown in  FIG. 4 , the clamp pads  76  generally include v-shaped cutouts such that when two of the clamp pads  76  are pushed together in the vial holder  54 , they generally form a diamond shape. Generally, there are two v-shaped cuts formed in each clamp pad  76 , so that two vials  14  may be secured when the corresponding clamp pads  76  are pushed together. The vial holder  54  preferably holds four vials  14  at a time, requiring a total of four clamp pads  76 . The clamp pads  76  are preferably an extruded polyurethane material.  
      As further shown in  FIGS. 11-14 , the vial clamping mechanism  75  further includes inner spreader plates  86  and outer spreader plates  88 . The spreader plates  86 , 88  include channels  89  which receive the pin  87  ( FIG. 13 ) from the clamp plates  78 . The spreader plates  86 ,  88  are operably connected to the clamp plates  78  such that vertical movement of the spreader plates  86 , 88  translates into lateral movement of the clamp plates  78  and attached clamp pads  76 . The channel  89  is angled such that when the spreader plates  86 , 88  are moved upward relative to the pin  87 , which is fixed in the clamp plate  78 , the clamp plates  78  move outward and open the vial holder  54  as shown in  FIG. 13 . The vial holder  54  may generally be opened either by pushing up on the spreader plates  86 ,  88 , or by directly pulling the clamp plates  78  apart. The access slots  72  on the bottom plate  66  allow the spreader plates  86 ,  88  to be pushed upward from the bottom of the vial holder  54 , opening the vial holder  54 . As further shown in  FIGS. 4 and 14 , it is understood that the vial clamping mechanism  75  can hold the vial  14  in varying linear positions within the vial holder  54 . Thus, the vial  14  can be placed in the vial holder  54  and held in place by the vial clamping mechanism  75  at differing vertical locations along the clamp pads  76  as desired.  
      As will be described in greater detail below, the vial pallet  27  receives and supports a plurality of reconstitution devices  10  and vials  14 . In a preferred embodiment, the reconstitution device holder  31  holds four reconstitution devices  10 , and the container holder  54  holds four vials  14 . The container holder  54  is moveable on the vial pallet  27  from a first position, or unstacked position, to a second position, or stacked position wherein the vials  14  are positioned to be connected to the reconstitution devices  10 . In the stacked position the coaxially arranged reconstitution devices  10  and vials  14  are easily connected by creating relative movement between the vials  14  and devices  10  and in one embodiment, by pushing on the devices  10  until the vials  14  snap into place in the gripper assemblies  28  of the reconstitution devices  10 .  
      The vial pallet  27  may also be equipped with a dosimeter assembly for the purpose of sterility verification. The dosimeter assembly is positioned on the vial pallet  27  and allows for routine monitoring of dose in the sterile connection between the reconstitution device  10  and vial  14 . The dosimeter assembly provides feedback to assure that a sterile connection has been achieved as will be described in greater detail below. The dosimeter assembly is also described in greater detail in commonly-owned U.S. application. Ser. No. ______ (Attorney Docket No. DDR-6099 (1417G P 844)), entitled “Method And Apparatus For Validation Of Sterilization Process,” filed concurrently herewith, which application is incorporated by reference and made a part hereof.  
      Vial Pallet Transport Assembly  90  (Vial Pallet Conveyor)  
       FIG. 3  shows an overview of the entire reconstitution assembly apparatus  21  including a vial pallet transport assembly  90 , upon which the vial pallet  27  is supported and conveyed. The vial pallet transport assembly  90  generally includes a powered conveyor  92  for transporting and positioning the vial pallet  27  to different portions of the assembly apparatus  21 . The powered conveyor  92  generally includes multiple sections of conveyor which may include belts and drive units. The preferred embodiment utilizes a power and free conveyor which is known in the relevant art.  
      In addition to a powered conveyor  92 , the vial pallet transport assembly  90  may include additional components such as cross-transfers, lift and rotate units, lift and locate units, and lift gates positioned as necessary to position and transport the vial pallet  27  through the apparatus  21 . The specific position of these components may be adjusted as necessary to move and position the vial pallet  27  as desired. The specific application of these components within a pallet transport assembly is understood by those of ordinary skill in the art. The vial pallet transport assembly  90  generally transports the vial pallet  27  between a device loading position, a vial loading position, a vial pallet stacking position, a first connecting position, a vial pallet unstacking position, and a vial and device subassembly transfer position. Each of these positions will be described in more detail below.  
      The vial pallet transport assembly  90  transports the vial pallet  27  between various modules and stations of the apparatus  21  that comprise the various positions mentioned above. Proximate to various pallet loading and unloading stations, and at various other queue positions along the powered conveyor  92 , are soft-stop units for locating and positioning the vial pallets  27  as they proceed through the apparatus  21  along the vial pallet transport assembly  90 . The position and specific function of each of these soft-stop units will be described in further detail when the use and operation of the apparatus  21  is described below.  
      Device Loader Module  94   
      The vial pallet  27  positioned on the vial pallet transport assembly  90  is preferably loaded with a reconstitution device  10  by the device loader module  94 . The device loader module  94  generally handles a plurality of reconstitution devices  10  simultaneously, and in a preferred embodiment, loads four reconstitution devices  10  at a time onto the vial pallet  27 . The preferred position of the device loader module  94  within the reconstitution assembly apparatus  21  is shown generally in  FIG. 3 . The device loader module  94  and its components are shown in greater detail in  FIGS. 15-23 .  
      The device loader module  94  generally includes a reconstitution device receiver  96  ( FIGS. 15-16 ), a rotary dial-index table  104  ( FIGS. 17-18 ), transport tracks  130  ( FIG. 19 ), a device presentation nest  136  ( FIG. 19 ) and a transport robot  146  ( FIG. 19 ). Each of these components of the device loader module  94  are preferably mounted on one or more base tables to position the components at an elevation level proximate to that of the vial pallet transport assembly  90 .  
      The reconstitution device receiver  96  is generally where reconstitution devices  10  are fed into the device loader module  94  for eventual delivery to the vial pallet  27 . The reconstitution device receiver  96  is preferably a vibratory bowl feeder which generally includes a loading bin  98 , a vibrating bowl  99 , and a discharge chute  100 . Attached to the vibrating bowl  99  is preferably a vibrating motor  102 . The vibrating bowl  99  is configured to position each of the reconstitution devices fed into the loading bin  98  such that each can be fed to the discharge chute  100  in the same position. The reconstitution devices  10  are generally positioned in a vertical position by the receiver  96  wherein the gripper assembly  28  of the device  10  faces generally upwards. Once the vibrating bowl  99  delivers the devices, the discharge chute  100  generally supports the reconstitution devices  10  at the gripper assembly portion of the devices  10 . The discharge chute  100  then preferably carries a continuous line of reconstitution devices  10  to the rotary dial-index table  104 .  
      The rotary dial-index table  104  is shown in  FIGS. 17 and 18 . The table  104  generally includes a servo driver unit  106 , device fixture nests  110 , a reject inspection system  112  and a device off-load assembly  126 . The servo driver unit  106  rotates a turntable  108  which supports the plurality of device fixture nests  110  at a radial periphery of the turntable  108 . Reconstitution devices  10  are loaded into the device fixture nests  110  from the discharge chute  100 .  
      The turntable  108  of the rotary dial-index table  104  preferably rotates in a counter-clockwise direction. The device fixture nests  110  receive reconstitution devices  10  from the discharge chute  100 . As the turntable  108  rotates, the reconstitution devices  10  loaded into the device fixture nests  110  are preferably inspected by an inspection system  112 . As further shown in  FIGS. 17 and 18 , the inspection system  112  generally includes a plurality of cameras  114  and lights  116 . Cameras  114  are generally positioned both below and next to the rotary dial-index table  104 . A reject shucker assembly  118  is preferably mounted to the rotary dial-index table  104 . The reject shucker assembly  118  generally includes a pneumatic actuator  120  and device transfer tool  122 . Rejected parts are shucked to a reject chute  124  which generally leads to a reject collection area. The device  10  may be rejected if it has not been properly preassembled to become part of the reconstitution assembly  1 . For example, if a septum component has not been properly positioned in the device  10 , the cameras  114  will detect this omission and indicate that the device  10  should be rejected.  
      The turntable  108  of the rotary dial-index table  104  continues to rotate in a counter-clockwise direction and places, in turn, each device fixture nest  110  next to the device off-load assembly  126 . The device off-load assembly  126  generally includes one or more device shuckers  128 , preferably two device shuckers  128 . The two device shuckers  128  off load the reconstitution devices  10  to the transport tracks  130 . In a preferred embodiment, there are two transport tracks  130  located proximate to the turntable  108 .  
      The transport tracks  130  generally include two rails  132  upon which the reconstitution devices  10  are supported, generally at the gripper assembly portion of the device  10 . The transport tracks  132  preferably further include a vibratory motor. As shown in  FIG. 17 , the devices  10  are moved along the transport tracks  130 . The transport tracks  130  generally include anti-shingling features.  
      As shown in  FIG. 19 , at the end of the transport tracks  130  opposite to the rotary dial-index table  104  is generally the device presentation nest  136 . The device presentation nest  136  is movable to various positions to receive reconstitution devices  10  in preparation for the devices  10  to be loaded onto the vial pallet  27 . The various positions are shown in  FIGS. 20-22 . The presentation nest  136  generally includes a base  138  with four individual device nests  140 . The device nests  140  preferably include part present sensors  142 . The base  138  is moved and controlled by an actuator  144 . The actuator  144  is preferably a three position pneumatic actuator.  
      As further shown in  FIG. 19 , proximate to the presentation nest  136  is the transfer robot  146 . The transfer robot  146  is of a type generally known in the art that is capable of grasping reconstitution devices  10  from the device presentation nest  136  and transferring the devices  10  to the vial pallet  27 . The transfer robot  146  generally includes a robot arm  148  and a device picking tool  150 . The device picking tool  150  generally includes part grippers  152 .  
      Station guarding is preferably built around any potentially dangerous moving parts of the device loader module  94 .  
      Container (Vial) Loader Module  154   
      After a reconstitution device  10  has been loaded onto the vial pallet  27 , the vial pallet  27  is preferably conveyed by the vial pallet transfer assembly  90  to the container loader module  154 . The container loader module  154  is shown generally in  FIG. 3  and is located proximate the vial pallet transport assembly  90  and downstream of the device loader module  94 . The container loader module  154  is also shown in  FIGS. 24-33 . The container loader module  154  preferably supplies and loads containers  14  to the vial pallet  27 . As discussed, the containers  14  are preferably vials, and the container loader module  154  will alternatively be referred to as the vial loader module  154 , although it can be appreciated that other types of containers could be used.  
      A first embodiment of the vial loader module  154  is shown in  FIG. 24 , and generally includes an accumulating conveyor  158 , a container transfer robot  188 , an inspection assembly  192 , an uncap mechanism  202 , a pallet load robot  210  and a vial holder opener  227 .  
      The accumulating conveyor  158  is generally mounted on a station base table assembly  156 . The accumulating conveyor  158  is preferably arranged to circulate vials  14  from a loading station  160  to a vial presentation fixture  162 . The accumulating conveyor  158  generally includes a first accumulating conveyor  164  and a second accumulating conveyor  166  separated by a partition  168 . Proximate to an end of the first conveyor  164  are located four separator lanes  170 , each of which is sized to receive a vial  14 . The entrances to the four separator lanes  170  are preferably offset from one another along an angle such that vials  14  in excess of the number required to fill the lanes  170  are conveyed to the second accumulating conveyor  166  through an opening in the partition  168 . The four separator lanes  170  are generally formed by a plurality of spaced guide rails  172 . The guide rails  172  are preferably adjustable to allow for different sized vials  14  which may be conveyed through the system  21 . The second conveyor  166  includes an angled member  174  which conveys the vials  14  back to the first conveyor  164  through another opening in the partition  168 . In this fashion, the vials  14  are circulated by the first and second accumulating conveyors  164 , 166 .  
      Loading of the accumulating conveyor  158  is generally performed at the loading station  160 . The loading station  160  preferably includes a container holding tray  176 . Containers/vials  14  are generally placed onto the tray  176  in an upright fashion. A plow  178  generally pushes forward to introduce the vials  14  to the first accumulating conveyor  164 .  
      The presentation fixture  162  is shown in more detail in  FIG. 25 . The presentation fixture  162  preferably includes a base  180  having extensions  182  which form v-shaped slots  184 , and is generally termed a v-block fixture. The presentation fixture  162  preferably includes sensors  186  for container detection. The sensors are preferably ultra-sonic sensors. The accumulating conveyor  158  generally delivers vials  14  to the vial presentation fixture  162 .  
      As shown in  FIG. 24 , the container transfer robot  188  is positioned proximate to the presentation fixture  162  for transferring the vials  14  from the vial presentation fixture  162  at the accumulating conveyor  158 . The container transfer robot  188  is further shown in  FIG. 26 . The container transfer robot  188  generally includes a robot arm  190  and end of arm tooling  191  customized to pick the particular container being picked. Preferably, the tooling includes two gripping elements which close about a respective neck of the vials  14 . The robot arm  190  raises the picked vials  14  and carries them to the inspection assembly  192 . The vials  14  are generally positioned or moved by the container transfer robot  188  such that they may inspected by the inspection assembly  192  while being held by the container transfer robot  188 .  
      As shown in  FIG. 24 , the inspection assembly  192  generally includes a camera  194 , and more preferably a plurality of cameras  194  including three individual cameras  194 . The inspection assembly  192  may also include mirrors used in conjunction with the cameras  194  to inspect the containers  14 . The vials  14  are generally moved past the cameras  194  such that indicia contained on the container  14 , such as a label, may be viewed by the cameras  194 . The inspection assembly  192  preferably detects reject vials  14  which are damaged, or which have a damaged or incorrect label. Other embodiments of the inspection assembly may use other methods of detecting rejects such as bar code or radio frequency detection systems.  
      The inspection assembly  192  inspects the containers  14  and rejected containers are offloaded by the container transfer robot  188  onto a reject offload conveyor  200  for later operator attention. Vials  14  are generally inspected in batches of four vials  14 . Acceptable vials  14  in a batch that contains a reject vial  14  are generally placed back onto the accumulating conveyor  158  by the container transfer robot  188  for recycling through the container loader module  154 .  
      The container transfer robot  188  is also proximate to the uncap mechanism  202 . Good batches containing no reject vials  14  are generally transported by the container transfer robot  188  to the uncap mechanism  202 .  
      The uncap mechanism  202  is shown in greater detail in  FIG. 27  and generally removes a cap that is typically part of a vial as shipped from, for example, a pharmaceutical company. The uncap mechanism  202  generally includes two container holders  204 ,  205  mounted on a rotary actuator  208  for inverting the vials  14  following removal of the cap from the vials  14 . The uncap mechanism  202  also generally includes an opening mechanism  206 .  
      The container holders  204 ,  205  preferably include tooling which generally grasps the neck of the vials  14  leaving the cap exposed. The cap is generally a soft metal crimp ring, such as aluminum, which crimped around the rubber stopper and neck of the vial  14 . Each container holder  204 ,  205  generally includes tooling for gripping four vials  14  simultaneously. The container holders  204 ,  205  are preferably mounted opposite to one another on the rotary actuator  208  as shown in  FIG. 27 . The two container holders  204 ,  205  are positioned such that when the rotary actuator  208  is in a first operating position, vials  14  held in the first container holder  204  are proximate to and accessible by the opening mechanism  206 , and at the same time vials  14  held in the second container holder  205  are proximate to and accessible by a pallet load robot  210  ( FIG. 26 ).  
      The opening mechanism  206  generally includes an actuator  212  which lowers a gripper  214  to the capped vials  14 . The gripper  214  generally includes fingers for gripping the cap. The gripper  214  removes the cap, or a portion of the cap, and places it into a disposal chute  216  which leads to a cap collection bin  217  ( FIG. 26 ). The actuator  212  then preferably actuates and returns the gripper  214  to its original position. The actuator  212  is preferably a pneumatic actuator. It is understood that the cap may be in different forms and may be removable in different forms. For example, the vial  14  may have a cap that is removable to expose the crimp ring wherein the crimp ring has an opening to define a target site on the stopper of the vial  14 .  
      After the caps have been removed from the vials  14 , the rotary actuator  208  rotates. This rotation inverts the now uncapped vials  14  in the first container holder  204  and positions the vials  14  proximate to the pallet load robot  210 . The rotation at the same time places the second container holder  205  proximate to the container transfer robot  188  for the loading of inspected, but still capped vials  14 . The uncapped vials  14  positioned in the first container holder  204  in an inverted position are then transferred to the pallet load robot  210 .  
      The pallet load robot  210  is shown and described in conjunction with  FIGS. 28-31 . The pallet load robot  210  generally moves vials  14  from the uncap mechanism assembly  202  into the vial pallet  27 . The pallet load robot  210  generally includes a robotic arm  218 , an end of arm tooling assembly  220 , and may include a vacuum and blow-off assembly  221  ( FIG. 24 ). The robotic arm  218  generally allows for moving the tooling assembly  220  between the container holder  204  holding uncapped vials  14  in an inverted position, and the vial holder  54  of the vial pallet  27  located on the vial pallet transport assembly  90 . The pallet load robot  210  is preferably fixed to a station base table assembly on a pedestal.  
      As shown in  FIGS. 30 and 31 , the end of arm tooling assembly  220  generally includes suction cups  222 , for securing the vials  14 . A positive vacuum is applied through a line  224  in the suction cups  222 . Preferably there are four suction cups  222  aligned in a row on the end of arm tooling assembly  220 . The suction cups  222  are supported by the pallet load robot  210 . The robot arm  218  positions the end of arm tooling  220 , and an actuator  226  raises and lowers the suction cups  222  as needed. The suction cups  222  preferably form a tight seal with the bottom surface of the vials  14 , and holds them securely while the end of arm tooling assembly  220  is moved. The end of arm tooling assembly  220  preferably can be easily changed out to accommodate vials  14  of different sizes.  
      As shown in  FIG. 24 , the vacuum and blow-off assembly  221  is generally positioned between the uncap mechanism  202  and the vial pallet transport assembly  90  on the station base table assembly  156 . The vacuum and blow-off assembly  221  removes any contaminants or undesirable matter on the vials  14  after uncapping.  
      As shown in  FIG. 28 , the vial pallet  27  is generally positioned proximate to the pallet load robot  210  for loading of the vial  14  onto the vial pallet  27 . The container loader module  154  also generally includes the vial holder opener  227  which is positioned beneath the vial pallet transport assembly  90 . As shown in  FIGS. 32-33 , the vial holder opener  227  generally includes a pallet lift  228  and a vial holder release mechanism  230 , both of which are positioned below the powered conveyor  92 .  
      The pallet lift  228  is shown in more detail in  FIGS. 32 and 33  and generally includes a pallet support  232 , a lift assembly  234  and a pallet hold down  240  ( FIG. 28 ). The lift assembly  234  generally includes a pneumatic actuator  236  that actuates the raising and lowering of the pallet support  232  by a lift shaft  238 . The pallet hold down  240 , as shown in  FIG. 28 , generally defines the upper limit of movement for the vial pallet  27  when it is lifted by the pallet lift  228 . The pallet hold down  240  generally holds the vial pallet  27  securely in conjunction with the pallet support  232 . The pallet hold down  240  generally includes brackets  242  each with a horizontal extension  244  which contacts a top surface of the vial holder  54  of the vial pallet  27  when the pallet lift  228  is in a raised position. As shown in  FIG. 28 , the pallet hold down  240  is generally supported by a support bar  245 .  
      The vial holder release mechanism  230 , as shown in  FIGS. 32 and 33  generally includes an unlatch mechanism  248 . The vial holder release mechanism  230  preferably moves in conjunction with the pallet lift  228 . In other embodiments, the vial holder release mechanism  230  may move independently of the pallet lift  228 . The unlatch mechanism  248  generally includes an extending rod  254  ( FIG. 33 ). The extending rod  254  is movable from a retracted position to an extended position. In the extended position the extending rod  254  preferably extends through the base plate  29   a  of the vial pallet  27  and engages the internal slide  56  of the container holder supports  50 . The internal slide  56  is then forced upwards into the spreader plates  86 , 88  within the vial holder  54 , opening the vial holder  54  so the vials  14  may be loaded. After the vials  14  have been loaded, the vial holder release mechanism  230  retracts and the clamp pads  76  of the vial holder  54  close around the vials  14 . It is understood that the pallet load robot  210  can be programmed and adjusted so as to place the vials  14  within the vial holder  54  at a certain desired vertical location within the vial holder  54 . Thus, the particular position at which the clamp pads  76  engage and hold the vials  14  can be varied and controlled as desired. Such ability to control the placement and position of the vials  14  within the vial holder  54  enhances the sterile connection between the vials  14  and the devices  10  as will be described in greater detail below.  
       FIGS. 24A and 26A  show another embodiment of a container loader module  154 A. This second embodiment is similar to the first embodiment described in detail above, with the exception of a modified inspection assembly  610  and container transfer robot  612 . The container loader module  154 A of  FIGS. 24A and 26A  generally includes an accumulating conveyor  158 , the modified inspection assembly  610 , the modified container transfer robot  612 , an uncap mechanism  202 , a pallet load robot  210  and a vial holder opener  227 .  
      Each of the components of the container loader module  154  of  FIGS. 24A and 26A , with the exception of the modified inspection assembly  610  and container transfer robot  612 , have been previously described, and are generally similar in this second embodiment.  
      The modified inspection assembly  610  generally includes an inspection load robot  614 , a vial rotator  616 , and a camera assembly  618 .  
      The inspection load robot  612  generally includes a robot arm  620  and an end of arm tooling  622 . The inspection load robot  612  moves the robot arm  620  such that the end of arm tooling  622  is positioned above the vial presentation fixture  162  of the accumulating conveyor  158 . The end of arm tooling  622  picks vials  14  from the vial presentation fixture  162 , preferably four at a time. The robot arm  620  then moves the end of arm tooling  622  and vials  14  to the vial rotator  616 .  
      The vials  14  are generally then deposited into the vial rotator  616 . The vial rotator  616  generally includes a vial receiver  624  and a rotating belt  626 . The vial receiver  624  receives and secures the vials  14  from the end of arm tooling  622 . While positioned in the vial receiver  624 , the vials  14  are preferably rotatable 360° such that a label on the vials  14  may be fully viewed and inspected by the camera assembly  618 .  
      The camera assembly  618  generally includes cameras  628  and lights  630 . Generally one camera  628  is provided for each vial  14 , and here, four cameras  628  are present. The lights  630  cast illumination upon the vials  14  to facilitate inspection by the cameras  628 . Vials  14  are generally loaded into the vial rotator  616 , inspected by the camera assembly  618 , and then picked by the modified container transfer robot  612 . The container transfer robot  612  moves rejected containers onto the reject offload conveyor  200  for later operator attention. Vials  14  are generally inspected in batches of four vials  14 . Acceptable vials  14  in a batch that contains a reject vial  14  are generally placed back onto the accumulating conveyor  158  by the container transfer robot  612  for recycling through the container loader module  154 A.  
      The container transfer robot  612  is also proximate to the uncap mechanism  202 . Good batches containing no reject vials  14  are transported by the container transfer robot  612  directly to the uncap mechanism  202 . From the uncap mechanism  202  the vials  14  are loaded unto the vial pallet  27 .  
      Generally, the station includes guarding built around the unit to keep personnel safely away from potentially hazardous moving parts.  
      Vial Holder Placement Module  260   
      Once the reconstitution device  10  and vial  14  are loaded onto the vial pallet  27 , the pallet  27  is preferably transported by the vial pallet transport assembly  90  to a vial holder placement module  260  as shown in  FIGS. 3 and 34 . As shown in  FIG. 3 , the vial holder placement module is positioned generally downstream of the container loader module  154  and before the vial/device sterilization booth  270 . As shown in  FIG. 34 , the vial holder placement module  260  generally includes a station base frame  262 , a pick and place unit  264  and a lift and locate unit  266 . As will be described in greater detail below, the vial holder placement module  260  moves the vial holder  54  with vials  14  from its initial position to the stacked or connecting position in preparation for the vials  14  to be connected to the respective reconstitution devices  10 .  
      Vial/Device Sterilization Booth  270   
      In the preferred embodiment of the sterilization system  21 , the system  21  comprises two sterilization booths: a vial/device sterilization booth  270  as shown in  FIG. 35 , and a bag/device sterilization booth  520 , as shown in  FIG. 55 . The two booths  270 ,  520  are similar in many respects. However, differences exist between the booths  270 , 520 . The vial/device sterilization booth  270  will be described in detail here, and the bag/device sterilization booth  520  will be described separately, making reference to those features which are similar and those which are different.  
      It is important to note that there are different levels of sterilization. Therefore, a discussion on the topic must begin with the selection of a desired sterility assurance level (SAL), a measure of the probability that one unit in a batch will remain non-sterile after being exposed to a specific sterilant. For example, an SAL of 10 −3  means that one device in a thousand may be non-sterile. Selecting the proper SAL may occur during a dose-setting phase of radiation sterilization validation. In many cases, the intended use of the device to be sterilized will dictate the need for a particular SAL. The commonly accepted SAL for invasive medical devices is 10 −6 . However, some European countries only recognize 10 −6  SAL for a claim of “sterile.” In such cases, the country of intended use will dictate the SAL as much as the device&#39;s intended use. It is understood that the sterilization sources are selected according to the desired or required levels of sterility assurance.  
      Referring to  FIGS. 35-38 , a preferred embodiment of the system  21  for sterilely connecting a container  14  and a reconstitution device  10  comprises a vial/device sterilization booth  270 . The sterilization booth  270  generally includes a housing  277 , a sterilization source or sterilizing emitter assembly  285 , and a connecting mechanism  306 .  
      As shown in  FIG. 36 , the sterilization booth  270  generally is divided into three chambers, a sterilization chamber  272 , a pre-sterilization chamber  274 , and a post sterilization chamber  276 . The housing  277  of the sterilization booth  270  divides the booth  270  into the sterilization chamber  272 , pre-sterilization chamber  274 , and post sterilization chamber  276 , and generally provides shielding from the environment external to the sterilization booth  270 .  
      Each chamber generally includes doors, generally a set of entrance doors and a set of exit doors. In the preferred embodiment, each individual door includes two panels which slide apart to open the door. The panels are preferably comprised of a lead core with a stainless steel exterior lining.  
      Referring to  FIG. 36 , the entrance doors  278  for the pre-sterilization chamber  274  are shown. The exit doors  280  for the pre-sterilization chamber  274  also act as the entrance doors for the sterilization chamber  272 . Likewise, the sterilization chamber exit doors  282  also function as the post-sterilization chamber entrance doors. The exit doors  284  for the post-sterilization chamber  276  are also shown. The doors are preferably sliding doors actuated by, for example, a hydraulic source reacting to a sensor (not shown) and a control system (not shown). These components are well known by those skilled in the relevant art and implementation of such components would be well understood.  
      The sterilization booth housing  277  is preferably arranged to prevent exposure outside of the sterilization booth  270  to the sterilization source  285 . In a preferred embodiment, radiation created by a low-energy electron beam (e-beam) source functions as the sterilization source  285 , and the sterilization booth housing  277  includes shielding to prevent undesired outside exposure. Use of a higher energy source may require additional shielding. The housing  277  is also comprised of an appropriate ventilator  287  due to the creation of exhaust, generally ozone, from the sterilization source.  
      The sterilizing emitter assembly  285  ( FIG. 37 ) generally includes a low energy e-beam source  286  and a vial pallet shielding  289 . The e-beam source  286  is arranged to provide a sterilizing dose of e-beam radiation at a location contemplated for the connecting of the vial  14  and the reconstitution device  10 .  
      In one preferred embodiment, the e-beam source  286  generally comprises two oppositely positioned low-energy e-beam tubes  288 . Suitable e-beam tubes are commercially available from a number of different sources. These presently preferred e-beam tubes generally operate in the range of 60 to 150 KeV. The resulting electron field, or cloud, produced by each e-beam tube has been estimated at approximately 5 cm×25 cm×5 cm (h×w×d), but may vary considerably within the preferred range of energies and other factors. Other suitable electron beam tubes may exist and those skilled in the art would understand what modification would be necessary to implement such tubes into an embodiment of the present system.  
      The e-beam tubes  288  are generally supported by tube holders  291 . The tube holders  291  position the e-beam tubes such that an electron cloud or sterilizing field may be formed within the sterilization chamber  272 .  
      While two electron beam tubes are preferred for the present embodiment, it is contemplated that a single electron beam could be used in some applications. For example, the engaged components to be connected could be rotated within the resulting electron cloud to effect sterilization, or the source beam could revolve about the components for the same effect. Additionally, any number of electron beam tubes may be used in an array fashion to further address shadowing of very complicated connections or oddly shaped components.  
      While the preferred sterilization source  250  comprises low energy e-beams, other sterilization sources are contemplated for use in conjunction with the present invention. For example, alternative embodiments may include the use of a high energy e-beam sterilization source, a chemical vapor sterilization source, a gas discharge sterilization source, a steam sterilization source, and a pulse light sterilization source, among others.  
       FIG. 35  shows the sterilization chamber  272  with a vial pallet  27  contained therein. As explained in greater detail below, the vials  14  may have two positions within vial holder to enhance the sterilization process associated with the connection between the vial  14  and the device  10 . Within the sterilization chamber is a connection area to which the vial pallet  27  is conveyed and positioned for the contemplated sterile connection of the vial  14  and reconstitution device  10 . The e-beam tubes  288  are preferably positioned on two sides of the sterilization chamber  272 . The e-beam tubes  288  are arranged to form a sterilizing field within the connection area.  
      The vial pallet shielding  289  generally comprises movable shutters  294 ,  296  and a vial back-up mechanism  307 . The movable shutters  294 ,  296  are mounted on shutter support structures  298 ,  300 . The shutters include actuators  302 ,  304  which slide the shutters  294 ,  296  upward on demand. The shutters  294 ,  296  block the e-beam radiation from reaching the sterilization chamber  272  until they are moved upwards, preferably exposing the vial pallet  27 , to the e-beam radiation sterile field. The actuators  302 , 304  are preferably pneumatic cylinders. The shutters  294 ,  296  preferably include coolant ports  316  which provide a flow of a coolant through the shutters  294 ,  296 . The coolant preferably travels through each of the shutters in a boustrophedonic pattern.  
      The vial pallet shielding  289  also generally includes the vial back-up mechanism  307 , preferably positioned within the sterilization chamber  272 . The vial back-up mechanism  307  includes an electric servo-driven actuator  308 . A positioning shaft  310  extends downward from the actuator  308 . A vial holder shield  312  is mounted to the positioning shaft  310 . The vial holder shield  312  is a shielding metal such as steel, lead, or combinations thereof. The shield  312  is sized to fit in a top opening of the vial holder  54 , and shield the top of the vial holder  54 . A vial positioning tool  314  preferably extends downward from the vial holder shield  312 . The vial positioning tool  314  generally includes four extensions which fit into the diamond shaped openings of the vial holder  54  to access the vials  14  and further position the vials  14  as necessary or desired.  
      The vial pallet shielding  289  works cooperatively with the vial pallet  27  to shield the body of the vials  14  from the radiation while exposing a neck of the vials  14  such that the vials  14  may be connected to the reconstitution devices  10  within a sterilizing field. In particular, and as shown in  FIGS. 4, 35  and  35 A, the housing  59  of the vial holder  54  on the vial pallet  27 , and the vial holder shield  312  shield the vials  14 . In this manner, the vial pallet  27  and sterilization booth  270  work cooperatively to shield those parts of the containers that should be shielded while exposing those parts that are contemplated for connection within the sterilizing field.  
      As shown in  FIG. 37 , the sterilization booth  270  also includes the connecting mechanism  306  for connecting the vials  14  to the reconstitution devices  10 . The connecting mechanism  306  generally includes a snap-closure mechanism  320 . The snap-closure mechanism  320  is generally mounted to a base-plate  322  underneath the sterilization chamber  272 . The snap-closure mechanism  320  preferably includes four independent pneumatic cylinders  324 . The pneumatic cylinders  324  preferably include electronic position feedback sensors  326  ( FIG. 36 ).  
      The pre-sterilization chamber  274 , sterilization chamber  272 , and post-sterilization chamber  276  each preferably include an individual conveyor  328 . Each conveyor  328  moves the vial pallet  27  through a chamber of the sterilization booth  270 . The conveyors  328  may be considered as part of the vial pallet transport assembly  90 . The conveyors  328  are preferably toothed-belt type conveyors, but may be of any type. Preferably, each conveyor  328  includes its own motor  330 .  
      Vial Holder Removal Module  340   
      Preferably, after exiting the post-sterilization chamber  274  of the sterilization booth  270 , the vial pallet  27  is conveyed by a section of the vial pallet transfer assembly  90  to a vial holder removal module  340  as shown in  FIG. 39 . The vial holder removal module  340  generally moves the vial holder  54  of the vial pallet  27  from the stacked connecting position to its original unstacked position on the vial pallet  27 . The vial holder removal module  340  is similar to the vial holder placement module  260  of  FIG. 34 . The vial holder removal module  340  also generally includes a station base frame  342 , a pick and place unit  344  and a lift and locate unit  346 .  
      Preferably, when the vial holder  54  of the vial pallet  27  is placed into an unstacked unloading position, a reconstitution device/vial subassembly  349  remains in the vial holder  54  portion of the vial pallet  27  as shown in  FIGS. 40 and 41 . The reconstitution device/vial subassembly  349  is formed when the reconstitution device  10  and vial  14  are connected.  
      Depalletize Device/Vial Module  350   
      After the reconstitution device  10  and vial  14  are connected to form the reconstitution device/vial subassembly  349 , and the vial holder removal module  340  has moved the vial holder  54  onto the container holder supports  50  on the vial pallet, the vial pallet  27  is then preferably transferred by the vial pallet transport assembly  90  to the depalletize device/vial module  350 , as shown in  FIG. 41-44 .  
      The depalletize device/vial module  350  generally comprises a vial holder opener  351  and a transfer robot  354 . The vial holder opener  351  is preferably the same as the vial holder opener  227  discussed above in conjunction with the container loader module  154  and detailed in  FIGS. 32-33 . The vial holder opener  351  generally includes a pallet lift  352  and a vial holder release mechanism (not shown), both of which are positioned below the powered conveyor  92 .  
      The transfer robot  354  generally includes a robotic arm  356  and an end of arm tooling assembly  358 . The robotic arm  356  generally allows for moving the tooling assembly  358  between the vial holder  54  of the vial pallet  27  and the shrinkband applicator  360 . The transfer robot  354  is preferably fixed to a station base table assembly  361 .  
      The end of arm tooling assembly  358  generally includes suction cups  362  for securing the reconstitution device/vial subassemblies  349 . A positive vacuum is preferably applied through the suction cups  362 . Preferably there are four suction cups  362  aligned in a row on a support  364  which is then secured to the transfer robot  354 . Generally, the station includes guarding built around the unit to keep personnel safely away from potentially hazardous moving parts.  
      Shrinkband Applicator  360   
      The shrinkband applicator  360  generally includes a power and free puck conveyor  368 , a shrinkband application station  365  and an oven  367 , as shown in  FIGS. 3, 43 , and  44 . The puck conveyor  368  generally includes individual pucks  370  which are supported between guide rails  372  on a conveyor  374 . The individual pucks  370  receive reconstitution device/vial subassemblies  349  and transports them through the shrinkband application station  365  and the oven  367 . The puck conveyor  368  preferably includes a puck stop and locate assembly  378 . This assembly  378  preferably includes puck stops  380  and part present sensors  382 . As described in greater detail below, the shrinkband applicator  360  applies a shrinkband around the vial  14  and portion of the gripper assembly of the reconstitution device  10 , as shown in  FIG. 2A .  
      Second Cell: Bag/Device Subassembly Connection System  25   
      In one embodiment of the present invention the reconstitution assembly apparatus  21  includes a second cell  25  wherein the reconstitution device/vial subassembly  349  is sterilely joined to the first container  12 , preferably a flexible diluent container  12  as discussed. The flexible diluent container  12  is preferably a bag  12  as shown in  FIGS. 1 and 2 . The connection of the device/vial subassembly  349  to the bag  12  is preferably an automated process wherein the device/vial subassembly  349  and bag  12  are joined in a sterile manner.  
      As shown generally in  FIG. 3 , the second cell  25 , or bag/device subassembly connection system  25  generally includes a second positioning assembly, or bag pallet  402 , a bag pallet transport assembly  444 , a palletize device/vial subassembly module  448 , a bag load module  478 , a nozzle blow-off module  500 , a bag/device subassembly sterilization booth  520  and a depalletize reconstitution assembly module  568 .  
      While all of the modules will be described, it is appreciated that some modules could be altered or removed without moving out of the concept of the invention as claimed in the appended claim set. This understanding also applies to the modules described with respect to the vial/device connection system  23 .  
      Second Positioning Assembly  402  (Bag Pallet)  
      The bag pallet  402  is generally shown in  FIGS. 45-50 . As shown in  FIGS. 45 and 46 , the bag pallet  402  generally includes a pallet base  404 , a device/vial subassembly holder  408 , a container or bag holder  406 , and a support frame  424 . The various components of the bag pallet  402  are generally supported on the pallet base  404  and move through the second cell  25  on the pallet base  404 . The pallet base  404  generally has holes which pass through it aligned with the bag holder  406  such that the bag holder  406  may be pushed upwards by accessing it through the pallet base  404 .  
      The device and vial subassembly holder  408  of the bag pallet  402  generally includes a device gripper  410 , a device support block  430 , and a vertical mounting support  432 . The device/vial subassembly holder  408  is generally attached to the frame  424 . It should be understood that in other embodiments, the device/vial subassembly holder  48  may be simply a reconstitution device holder. This may occur when it is desirable to not attach a vial or other drug container to the reconstitution device, but only to connect the first container  12  to the reconstitution device  10 .  
      The device gripper  410  is shown in greater detail in  FIGS. 47-48 . The device gripper  410  is preferably sized to grasp a portion of the reconstitution device  10  of the device/vial subassembly  349  generally proximate to an end which is to be sterilely connected to the bag  12 . In this embodiment, the device gripper  410  generally includes activation members  412  and gripping members  414  pivotally joined to one another. As shown in  FIG. 47 , the activation members  412  are joined at a pivot  416  to the gripping members  414 . The activation members  414  and gripping members  414  are preferably formed from a continuous piece of material, preferably stainless steel. Attached to each of the gripping members  414  is a tension spring  418  which biases the device gripper  410  into a closed position.  
      The device support block  430  and the vertical mounting support  432  of the device/vial subassembly holder  408  are generally located above the device gripper  410 . The vertical mounting support  432  generally has a shape complementary to the shape of the device/vial subassembly  349  such that it provides support about a portion of the device/vial subassembly  349  when one is placed into the bag pallet  402 .  
      As also shown in  FIGS. 45 and 46 , the bag holder  406  generally includes a bag gripper  420  and a bag back support plate  436  arranged to hold the bag  16  within the bag pallet  402 . The bag gripper  420  preferably operates by the same pivoting mechanism of the device gripper  410  used to secure the device/vial subassembly  349 . The bag gripper  420  preferably also includes a shielding plate  422  positioned between the gripping members. The bag gripper  420  is generally mounted to the bag back support plate  436 . As shown in  FIG. 45 , the bag  12  is preferably suspended from the bag gripper  420 .  
      The bag back support plate  436  is preferably slidingly mounted to the frame  424  such that it may slide up and down within the bag pallet  402 . This is generally the mechanism by which a bag  12  placed into the bag holder subassembly  406  may be moved into contact with the device/vial subassembly  349  placed in the device/vial subassembly holder  408 .  
      As shown in  FIGS. 49 and 50 , the bag back support plate  436  generally includes a slide rail  438  and slide blocks  440  as shown in a disassembled bag pallet  402 . The slide rail  438  is generally secured to the frame  424 . The slide blocks  440  ride along the slide rail  438 , preferably on ball bearings, and are fixedly attached to the bag back support plate  436 . As further shown in  FIG. 45 , proximate to the bottom of the bag back support plate  436 , a bag support foot  442  is generally mounted to the bag back support plates  436 . Bumpers are generally secured to the bottom of each of the bag back support plates  436 .  
      The frame  424  is preferably fixed to the pallet base  404 . The frame  424  generally includes a rear shielding plate  426  and side shielding plates  428  which extend upwards from the base  404 . The rear shielding plate  426  and side shielding plates  428  are generally constructed of steel having sufficient thickness to shield the vial  14  and bag  12  from radiation and excessive heat. The bag pallet  402  generally is arranged to either on its own, or in cooperation with shielding components of a sterilization booth, shield the bag  12  and vial  14  in order to preserve the efficacy of the drugs or diluents typically stored therein. Exposure to radiation or other sterilizing effects can damage the safety and efficacy of many of the drugs typically stored in these containers.  
      The rear shielding plate  426  preferably includes a window  434 . The window  434  is generally simply an opening in the rear shielding plate  426 . The bag holder subassembly  406  is generally mounted to the rear shielding plate  426 . In the preferred embodiment, the bag pallet  402  allows for the mounting of four bag holder subassemblies  406  to the rear shielding plate  426  and four corresponding device and vial subassembly holders  408 .  
      Similar to the vial pallet  90 , the bag pallet  402  may also be equipped with a dosimeter assembly for the purpose of sterility verification. The dosimeter assembly is positioned on the bag pallet  402  to allow for the routine monitoring of dose in the sterile connection between the reconstitution device/vial subassembly  349  and the bag  12 . The dosimeter assembly provides feedback to assure that a sterile connection has been achieved as will be described in greater detail below. The dosimeter assembly is also described in greater detail in commonly-owned U.S. application Ser. No. ______ (Attorney Docket No. DDR-6609 (1417G P 844)), entitled “Method And Apparatus For Validation Of Sterilization Process,” filed concurrently herewith, which application has previously been incorporated by reference and made a part hereof.  
      Bag Pallet Transport Assembly  444   
      The bag pallet  402  is generally supported on, and conveyed through the second cell  25  by the use of a bag pallet transport assembly  444 , or bag pallet conveyor  444 . The bag pallet conveyor  444  is generally similar to the vial pallet transport assembly  90  of the first cell  23  in its component parts. It preferably includes a powered conveyor  446 . The powered conveyor  446  generally includes multiple sections of conveyor which include belts and drive units.  
      In addition to a powered conveyor  446 , the bag pallet transport assembly  444  preferably includes additional components such as cross-transfers, lift and rotate units, lift and locate units and lift gates positioned as necessary to transport the bag pallet  402  through the system. The specific position of these components may be adjusted as necessary to move and position the bag pallet  402  as required. The specific application of these components within a pallet transport assembly is understood by those of ordinary skill in the art.  
      The bag pallet transport assembly  444  transports the bag pallet  402  between various component loading and unloading stations. These generally include a bag loading position, a palletize device/vial subassembly position, a nozzle blow-off position, a connecting position, and a depalletize reconstitution assembly position. Proximate to these stations and at various other queue positions along the powered conveyor  446  are soft-stop units for locating and positioning the bag pallets  402  as they proceed through the system  21 . The position and specific function of each of these soft-stop units will be described in further detail when the operation of the system is described below.  
      Palletize Device/Vial Subassembly Module  448   
      The palletize device/vial subassembly module  448  generally loads the reconstitution device/vial subassemblies  349  onto the bag pallets  402  as shown in  FIG. 51 . The palletize device/vial subassembly module  448  generally includes a transfer robot  454  and a pallet release mechanism  464 . These components are generally mounted on a station base table  450 .  
      The transfer robot  452  generally includes a robot arm  454  and end of arm tooling  456 . The transfer robot  454  is generally positioned proximate to the shrinkband applicator station  360  which generally includes the power and free puck conveyor  368 . A puck stop and locate assembly  462  generally positions the pucks  370  on the power and free puck conveyor  360  to allow the transfer robot  454  to remove the device/vial subassemblies  349 , now with shrinkband applied, from the pucks  370 .  
      The end of arm tooling  456  of the transfer robot  452  preferably includes grippers  458  for grasping the device/vial subassemblies  349 . The end of arm tooling  456  preferably includes four grippers  458  on a single support  460  for the simultaneous loading of four device and vial subassemblies  349 . Actuators preferably control the positioning of the grippers  458  and the opening and closing of the grippers  458 .  
      The pallet release mechanism  464  of the palletize device/vial subassembly module  448  generally opens the device/vial subassembly holder  408  on the bag pallet  402 . The pallet release mechanism  464  is shown in  FIG. 52 . It preferably includes a positioning mechanism  466 , a release tool  468  and a bag pallet clamp  479 . The bag pallet claim  479  clamps down on the bag pallet  402  and prevents it from moving off of the bag pallet conveyor assembly  444 .  
      The positioning mechanism  466  generally includes a support  470  and a bag pallet sensor  472 . The release tool  468  generally includes an extendable cylinder  474  and a pushing member  476 . The extendable cylinder  474  preferably includes a pneumatic actuator which causes the extendable cylinder  474  to extend, placing the pushing member  476  into the gripper  410  of the device and vial subassembly holder  408 , opening the gripper  410  as shown in  FIG. 48 . The transfer robot  452  then preferably loads the device/vial subassembly  349  onto the bag pallet  402 . Station guarding is generally provided to shield moving parts of the palletize device and vial subassembly station  448 .  
      Bag Load Module  478   
      As shown in  FIG. 3 , bags  12  are generally loaded onto the bag pallet  402  at the bag load module  478 . The bag load module  478  generally includes a pallet loader  479 , a bag-offload station  480 , a label application conveyor  482  and a bag transfer conveyor  486 .  
      Preferably, the bag load station  478  includes two pallet loaders  479 , each of which generally includes a pneumatically driven bag pallet opener  488 . The bag pallet opener  488  generally opens the bag holder  406  of the bag pallet  402  to allow loading of the bags  12 . The bag pallet opener  488  is generally similar to the pallet release mechanism  464  for opening the device/vial subassembly holder  408  on the bag pallet  402  as shown in  FIG. 52 . One difference is generally in the positioning of the release tool, which is adjusted to open the bag gripper  496  rather than the device gripper  410 .  
      The pallet loaders  479  preferably utilize operators to manually load the bags  12  onto the bag pallet  402 . Other embodiments may replace the operator with an automated pallet loader, which generally includes a robot which places the bags onto the bag pallet after it has been opened by the bag pallet opener. It is understood that the bag  12  preferably is loaded with the port connector assembly of the device  10  pre-connected to the bag  12 . As will be shown, the port connector assembly of the device  10  is attached to the sleeve assembly of the vial/device subassembly  349 .  
      The bag-offload station  480  generally is supplied bags  12  from a label application conveyor  482 . The bags  12  may be labeled with a variety of different identification labels, including bar code, RFID or other types of identifying indicia. The label application conveyor  482  moves labeled bags  12  to a pick and place unit  484 . The pick and place unit  484  preferably includes a vacuum tooling used to grip the bags  12 . The pick and place unit  484  transfers the bags to the bag transfer conveyor  486 . The bag transfer conveyor  486  is preferably a chain link conveyor. The bags  16  then move along the bag transfer conveyor  486  to the pallet loaders  479 .  
      Nozzle Blow-Off Module  500   
      The loaded bag pallet  402  generally proceeds along the bag pallet conveyor assembly  444  to a nozzle blow-off module  500 , as shown in  FIGS. 53-54 . The nozzle blow-off module  500  removes any water droplets or particulate contaminants from a port connector  30  of the bag  12 , and optionally also from the reconstitution device  10 . The nozzle blow-off module  500  generally includes a housing  502  and a blower assembly  506 .  
      The housing  502  generally includes a base table assembly  504  and a shield cover. The base table assembly  504  generally supports the other components of the nozzle blow-off module  500  and positions them generally level with the bag pallet  402  as it is conveyed by the bag pallet conveyor  444 . The shield cover is generally a plastic cover which surrounds the other components of the nozzle blow-off module  500 . The shield cover is generally supported on the base table assembly  504 .  
      The blower  506  is preferably contained within the housing  502 . The blower assembly  506  generally includes a blower  508  and a vacuum  514 . The blower  508  is supported on a movable automated support  510 . The automated support  510  generally includes an actuator which positions the blower  508  proximate to the bag  12 , which is supported on the bag pallet  402  as shown in  FIG. 54 . The blower  506  preferably includes four nozzles  512  to correspond to the four bags  12  which are generally positioned in the bag pallet  402 . The actuator is preferably a pneumatic actuator.  
      The vacuum  514  of the blower assembly  506  is also preferably supported on a movable automated support  516  having an actuator which moves the vacuum  514  proximate to the bag pallet  402  such that the bag  16  is positioned between the blower nozzle  512  and the vacuum  514 . The vacuum automated support  516  actuator is also preferably a pneumatic actuator.  
      Bag/Device Subassembly Sterilization Booth  520   
      The loaded bag pallet  402  is generally conveyed to the bag/device subassembly sterilization booth  520  as shown in  FIGS. 55-58 . The bag/device sterilization booth  520  is similar to the previously described vial/device sterilization booth  270 . The bag/device sterilization booth  520  generally includes a housing  519 , a sterilizing emitter assembly  524 , a heat shield  548 , and a connecting mechanism  557 .  
      Further, as stated previously, there are different levels of sterilization. Therefore, a discussion on the topic must begin with the selection of a desired sterility assurance level (SAL), a measure of the probability that one unit in a batch will remain non-sterile after being exposed to a specific sterilant. For example, an SAL of 10 −3  means that one device in a thousand may be non-sterile. Selecting the proper SAL may occur during a dose-setting phase of radiation sterilization validation. In many cases, the intended use of the device to be sterilized will dictate the need for a particular SAL. The commonly accepted SAL for invasive medical devices is 10 −6 . However, some European countries only recognize 10 −6  SAL for a claim of “sterile.” In such cases, the country of intended use will dictate the SAL as much as the device&#39;s intended use. It is understood that the sterilization sources are selected according to the desired or required levels of sterility assurance.  
      The housing  519  of the bag/device sterilization booth  520  is similar to the housing of the vial/device sterilization booth  270 . The housing  521  generally shields the external environment from any radiation generated by the sterilizing emitter assembly  524 . The housing  519  divides the bag/device sterilization booth  520  into a pre-sterilization chamber  521 , a post-sterilization chamber  522 , and a sterilization chamber  523 . The pre-sterilization chamber  521  and post-sterilization chamber  522  are similar to those of the vial/device sterilization booth  270  previously discussed. The sterilization chamber  523  of the bag/device sterilization booth  520  is different from that of the vial/device sterilization booth  270 , and is described in detail below. Each of the chambers preferably includes its own individual conveyor  565 . The bag/device sterilization booth  520  conveyors  565  are similar to those previously described in conjunction with the vial/device sterilization booth  270 . The conveyors  565  can be considered as part of the bag pallet conveyor  444 . The bag/device sterilization booth  520  also generally includes doors which are similar to those of the vial/device sterilization booth  270 .  
      The sterilization chamber  523  is generally arranged to accommodate the bag pallet  402  which is a second positioning assembly for properly positioning the bag  12  and reconstitution device/vial subassembly  439  for a sterile connection.  
      The sterilizing emitter assembly  524  generally includes a bag pallet shielding  525  and an e-beam source, which is preferably a pair of low energy e-beam tubes  527 . The e-beam source is generally arranged to provide a sterilizing dose to the bag pallet  402  at a location contemplated for the connecting of the bag  12  and reconstitution device/vial subassembly  439 . The location contemplated for the connecting of the bag  12  and the reconstitution device/vial subassembly  439  is the connection area. The e-beam tubes  527  preferably continuously emit, and the bag pallet shielding  525  generally shields the bag pallet  402  and the associated bag  12  and reconstitution device/vial subassembly  349  from undesired exposure.  
      The e-beam tubes  527  are generally two oppositely positioned low-energy e-beam tubes  527 . The preferred e-beam tubes  527  are generally similar to those used in conjunction with the vial/device sterilization booth  270 . The e-beam tubes  527  are preferably positioned in tube holders  528 . The tube holders  528  position the e-beam tubes such that an electron cloud or sterilizing field may be formed within the connection area of the sterilization chamber  522 . While two e-beam tubes are the preferred arrangement, other arrangements can be used while achieving the same beneficial results as described in conjunction with the vial/device sterilization booth  270 .  
       FIGS. 55-56  show the sterilization chamber  522  with a bag pallet  402  positioned in the chamber. The e-beam tubes  527  are preferably positioned on two sides of the sterilization chamber  522 .  
      The bag pallet shielding  525  generally comprises shutters  532 , 534 . The shutters  532 ,  534  are generally mounted on shutter support structures  536 , 538 . The shutters  532 , 534  generally include actuators  540 ,  542  which generally slide the shutters  536 ,  538  upward on demand. The shutters  536 ,  538  block the e-beam radiation from reaching the sterilization chamber  522  until they are moved upwards, preferably exposing a positioning assembly, such as the bag pallet  402 , to the e-beam radiation. The actuators  540 , 542  are preferably pneumatic cylinders. The shutters  536 , 538  preferably include coolant ports  544  which provide a flow of a coolant through the shutters  536 , 538 .  
      The bag/device subassembly sterilization booth  520  preferably also includes a heat shield  548 . The heat shield  548  generally includes an upper plate  550  and a lower plate  552 . The plates  550 ,  552  generally include cooling ports  554 , and are cooled by coolant flowing through the heat shield. The coolant preferably travels through the heat shield plates in a boustrophedonic pattern.  
      The heat shield  548  is generally sized to cooperatively engage the bag pallet  402  to protect the bag  12  and vial  14  contained in the bag pallet. The rear and sides of the bag pallet  402  are protected by the rear plates  426  and the side plates  428 . The top portion and front portion are exposed until the bag pallet  402  enters the sterilization chamber  522 . In the sterilization chamber  522  the front of the bag pallet  402  is shielded by the heat shield  548 . The top of the bag pallet  402  is generally shielded by a shielding bracket  556  in the sterilization chamber  522 . The shielding bracket  556  is preferably moved into a shielding position by an actuator after the bag pallet  402  is positioned in the sterilization chamber  522 . In this manner, the bag pallet and sterilization booth  520  work cooperatively to shield those parts of the containers that should be shielded while exposing those parts that are contemplated for connection within a sterile field.  
      The lower plate  552  of the heat shield is preferably movable vertically during the sterile connecting process. The lower plate  522  is generally pushed upwards by a connecting mechanism  557  when the bag  16  and device  12  are connected.  
      The connecting mechanism  557  generally includes a snap closure mechanism  558 . The snap closure mechanism  558  is generally mounted to a base plate  560  underneath the sterilization chamber  522 . The snap-closure mechanism  558  preferably includes four independent pneumatic cylinders  562 . The pneumatic cylinders  562  preferably include electronic position feedback sensors  564 . Additionally, extending members  566  are generally attached to the pneumatic cylinders  562 , and move in conjunction with the pneumatic cylinders  562 . The extending members  566  generally contact the lower plate  552  of the heat shield  548  and move it upward when the pneumatic cylinder  562  is actuated.  
      Locking Clip Placement Module  688   
      As shown in  FIGS. 2A, 65 , and  66 , in certain embodiments of the invention it may be desirable to place a locking device  670  onto the reconstitution device assembly  1 . In the preferred embodiment the locking device is a clip. Such a clip is shown in detail in  FIG. 66 , and is described in further detail in commonly-owned U.S. application Ser. No. ______ (Attorney Docket No. DDR-5392 A1 (1417B P 784)), entitled “Sliding Reconstitution Device For a Diluent Container,” filed concurrently herewith, the contents of which have previously been incorporated by reference into this specification.  
      As shown in  FIG. 65 , the locking device  670  generally functions as a means for preventing the premature activation of the reconstitution device  10  by restricting the relative movement of the sleeves of the reconstitution device.  
      The locking device  670  of  FIG. 66  generally includes a securing portion  672  and a gripping portion  674 . The securing portion  672  is that portion of the locking device  670  which attaches to the reconstitution device  10 . The securing portion  672  preferably extends about a portion of a first sleeve  32  ( FIG. 2A ). The securing portion  672  generally comprises a penannular cylinder having a radius generally equal to the radius of the exterior of the first sleeve  32 . The penannular cylinder has an opening sized to allow the first sleeve  32  to be snapped into and out of the penannular cylinder.  
      The gripping portion  674 , shown in  FIG. 66 , facilitates the securing and removal of the locking device  670  onto, or off of, the first sleeve  32 . The gripping portion generally includes two fins  676  which may be grasped simultaneously by a person using the thumb and forefinger of a single hand. The fins  676  preferably extend at an angle away from one another from where they are joined to a base portion of the locking device  670 .  
      The locking device  670  structure operates to maintain the sleeves in an axially fixed relative position. The locking device  670  has a portion that abuts the second sleeve  34  of the reconstitution device  10  and another portion that abuts a structure associated with the first sleeve  32 , or the first container  12 . Generally the locking device  602  abuts a flange of the port connector assembly  30  of the first container  12 . The other end of the locking device  670  abuts an end, or end flange of the second sleeve  34 , when the locking device  670  is secured to the reconstitution device  10 . Thus, the locking device  670  prevents the first sleeve  32  and the second sleeve  34  of the reconstitution device  10  from relative axial movement.  
      The locking device  670  is generally pushed onto the reconstitution device  10  at an optional locking clip placement module  688 , as shown in  FIG. 3 . The locking clip placement module  688 , when used, is preferably automated, but may simply position the reconstitution device assembly  1  such that the locking clip  670  may be positioned on the reconstitution device assembly  1  manually.  
      Depalletize Reconstitution Assembly Module  568   
      After the bag  12  and reconstitution device/vial sub-assembly  349  have been sterilely connected to form a reconstitution assembly  1 , the bag pallet  402  is preferably conveyed out of the sterilization booth  520  to a depalletize reconstitution assembly module  568  as shown in  FIGS. 3, 59  and  60 . The depalletize reconstitution assembly module  568  unloads the reconstitution assemblies  1 , and generally includes a station base table assembly  570 , pick and place assembly  572  and a pallet release mechanism  573 . The pick and place assembly  572  and pallet release mechanism  573  are preferably mounted to the station base table assembly  570 .  
      The pick and place assembly  572  preferably includes a device gripper  574  and a bag gripper  576 . The device gripper  574  is generally a pneumatic gripper sized to grip the reconstitution device  10 .  
      The bag gripper  576  preferably includes suction cups  578  through which a vacuum is applied to a bag surface  580  securing the bag  16  to the suction cups  578  as shown in  FIG. 59 . Vacuum lines  577  provide the vacuum at the openings of the suction cups  578 .  
      The device gripper  574  and bag gripper  576  are preferably mounted on a dual actuator support  582  having a linear actuator  579  and a rotational actuator  581 .  
      The depalletize reconstitution assembly module  568  also includes a pallet release mechanism for opening the grippers of the bag pallet. A pallet release mechanism has been described in conjunction with the palletize device/vial subassembly module  448  and with the bag load station  478 . The pallet release mechanism here is similar, but adds an additional set of release tools such that the device grippers and bag grippers may be opened simultaneously. The offloaded reconstitution assemblies  1  are generally moved off of the system  21  on a belt conveyor  584 .  
      Operation  
      Operation of the system  21  for the sterile connection of the reconstitution device  10  and a container  12 , 14  preferably involves the use of the sterilization booths  270 , 520 . Four sterilization booths, including two vial/device sterilization booths  270  and two bag/device subassembly sterilization type booths  520  operating on parallel tracks, are used in one preferred embodiment depicted in the system  21  shown in  FIG. 3 . The general operation of the system  21  in assembling and fabricating the reconstitution assembly  1  will now be described.  
      Operation of the Vial/Device Connection System  23  (First Cell)  
      Referring to  FIGS. 3 and 15 - 23 , the operation of the vial/device connection system  23  is more readily understood. The first module or station of the vial/device connection system  23  is generally the device loader module  94 . Preferably, a reconstitution device  10  is loaded onto a vial pallet  27  at this module. The device loader module  94  is preferably automated. Reconstitution devices  10  provided to the device loader module  94  are generally loaded into the vial pallet  27  without operator input.  
      An empty vial pallet  27  is generally moved into a position at the device loader module  94  on the vial pallet transport assembly  90 . Positioning of the vial pallet  27  is generally performed by a soft stop  586  incorporated into the vial pallet transport assembly  90  at the device loader module  94 . It is understood that a plurality of vial pallets  27  are loaded onto the vial pallet transport assembly  90 .  
      Reconstitution devices  10  are generally loaded into the vibratory bowl feeder  96  of  FIGS. 15-16 . From the vibratory bowl feeder  96 , the devices  10  are transferred to the rotary dial-index table  104  of  FIGS. 17-18  via the discharge chute  100 . The devices  10  are rotated by the rotary dial-index table  104  past the inspection system  112  where the devices  10  are inspected for deficiencies. Typical deficiencies that the inspection system  112  is preferably configured to detect include, for example, devices  10  having a defective septum, devices  10  missing a septum, or devices that have been prematurely activated. The reject shucker assembly  118  shucks rejected devices  10  to the reject chute  124 .  
      The rotary dial-index table  104  further rotates acceptable reconstitution devices  10  to the transport tracks  130 . The devices  10  are off-loaded to the transport tracks  130  by the device off-load assembly. The reconstitution devices  10  travel down the transport tracks  130  to the device presentation nest  136  as shown in  FIGS. 19-23 . The device presentation nest  136  is generally a three position pneumatic-actuated assembly. In a first position (A) as shown in  FIG. 20 , two reconstitution devices  10  are loaded into two of the four device nests  140  from the transport tracks  132 . The device presentation nest  136  then generally moves into a second position (B) and two more reconstitution devices  10  are loaded into the two remaining device nests  140  as shown in  FIG. 21 . The device presentation nest  136  then moves into a third position (C) as shown in  FIG. 22 . In the third position, the part grippers  152  mounted to the transfer robot  146  pick the four reconstitution devices  10  and remove them from the device presentation nest  136 , which then returns to first position (A) to repeat the cycle. The four reconstitution devices  10  are then transferred to the vial pallet  27  as shown in  FIGS. 19 and 23 .  
      After the reconstitution devices  10  have been loaded into the vial pallet  27 , the vial pallet  27  is conveyed to the second module or station by the vial pallet transport assembly  90 . A soft stop  588  positions the vial pallet  27  properly for loading of the vial  14 . The second module shown in  FIG. 3  is the vial container loader module  154 . In other embodiments, the order of the device loader module  94  and the vial container loader module  154  may be reversed.  
      The vials  14  are generally loaded onto the accumulating conveyor  158  either manually or automatically at the load station  160  as shown in  FIG. 24 . The vials  14  generally are capped vials with a metal seal crimped to the opening. The vial container loader module  154  is generally automated, and after loading, the vials  14  are preferably inspected, decapped, and automatically placed onto the vial pallet  27  without further operator input.  
      The vials  14  proceed through the accumulating conveyor  158  until they are positioned, preferably four at a time within the v-block fixture  162 , as shown in  FIG. 25 . The container transfer robot  188  then picks up the four vials  14  from the v-block fixture  162 , and moves them to the inspection assembly  192 . The vials  14  are inspected and any defective vials  14  are rejected and removed from the system. Acceptable vials  14  in a batch of four containing a reject vial  14  may be placed back onto the accumulating conveyor  158  and recycled. Where all four vials  14  in a batch are acceptable, the vials  14  are transferred to the uncap mechanism assembly  202 , as shown in  FIG. 27 . Here, the metal seal is removed, the vials  14  are inverted, and then the vial  14  are presented to the pallet load robot  210 .  
      Referring to  FIGS. 28 and 29 , the pallet load robot  210  generally transfers the batch of four vials  14  to the vial pallet  27 . The vial pallet  27  is lifted by the pallet lift  228 , shown in  FIGS. 33 and 34 , and the vial holder  54  portion of the vial pallet  27  is opened by the vial holder release mechanism  230 . The pallet load robot  210  then positions the vials  14  within the vial holder  54 . Once the vials  14  are positioned in the vial holder  54 , the vial holder release mechanism  230  closes the vial holder  54 . As discussed, the apparatus  21  can be pre-programmed to control the vertical position at which the vials  14  are loaded and held in the vial holder  54 . In one example, the apparatus  21  can be programmed to place and hold the vials  14  at different vertical locations in the vial holder  54  such as if different sized vials  14  are used in separate operational cycles of the apparatus  21 . Thus, the apparatus  21  can be programmed to alter the vertical position at which the vials  14  are placed and held in the vial holder  54 . The vial pallet  27  is then lowered by the pallet lift  228  to the vial pallet transport assembly  90 , and the pallet  27  is moved out of the vial loader module  154 . As shown in  FIG. 34 , from the vial loader module  154 , the now fully loaded vial pallet  27  is conveyed to the vial holder placement modules  260 .  
      Preferably, the system  21  includes redundancy of certain components including the vial holder placement modules  260 , the vial/device sterilization booths  270  and the vial holder removal modules  340  as shown in  FIG. 3 . These redundancies generally improve system efficiency.  
      At the vial holder placement modules  260 , the vial holder  54  is lifted off of the container holder supports  50  of the vial pallet  27  and placed atop the top holder supports  36  by the pick and place unit  264  and the lift and locate unit  266 . The pin holes  70  ( FIG. 11 ) of the vial holder  54  generally are aligned with and receive the locating pins  40  ( FIG. 4 ) of the top holder supports  36 . Placing the vial pallet  27  into this stacked connecting position vertically coaxially aligns the vial  14  and reconstitution device  10  so that they can be pushed together and connected to one another.  
      After the vial pallet  27  has been placed into the stacked connecting position as shown in  FIG. 35 , the vial pallet  27  is conveyed into the vial/device sterilization booth  270 . In the vial/device sterilization booth  270  ( FIG. 3 ), the vial  14  and reconstitution device  12  are sterilely connected to form the reconstitution device/vial subassembly  349  as was described above in detail ( FIGS. 1, 2 , and  2 A).  
      As discussed, the sterilization booths generally include a sterilization source, or radiation source which is preferably a low-energy electron beam source. By training the resulting electron clouds of electron beam tubes to overlap at the position of a pallet window of either a bag pallet or a vial pallet positioning device, an electron “flood area” is created. This flood area is the preferred location for connection of the components. The sterilizing field, or flood area, insures that sterilization is maintained at every corner, crevice, and surface of the components. That is, shadowing caused by juxtaposition of surfaces is minimized, if not eliminated. Electrons are scattered in the flood areas to aid in sterilization.  
       FIGS. 62-64  generally show the intersection of the component parts within the flood area  658  created by e-beam tubes  650 ,  652  according to the present invention. As shown in  FIG. 62 , the e-beams tubes  650 ,  652  each generally form an electron cloud  654 ,  656 . The e-beams  650 ,  652  are preferably positioned opposite to one another such that the electron clouds  654 ,  656  overlap to form an area of relatively concentrated radiation called the flood area  658  or sterilizing field. Electrons are scattered in the flood areas or sterilizing fields. As shown in  FIGS. 63 and 64 , the snap connection of a container  660 , which is typically either a drug vial or flexible diluent container, to a reconstitution device  662 , preferably occurs within the overlapping connection or flood area  658 . This arrangement is preferably used in both the vial/device sterilization booth  270  and the bag/device sterilization booth  520 .  
      The flood area  658  is preferably localized to the connection area in which the container/device connection is performed. For example referring to  FIG. 35 , in the vial/device sterilization booth  270 , the flood area preferably encompasses the area in which the four connections between the vial  14  and the reconstitution device  10  are made within the vial pallet  27 . When the vial pallet  27  is in the stacked connecting position with the vial holder  54  stacked on top of the device holder subassemblies  35 , as shown in  FIG. 10 , a window is created between the vial holder  54  and the device holder subassemblies  35 . This window exposes a portion of the drug vial  14  and the gripper assembly of the reconstitution device  10  to any electron beam cloud which may be present. In this manner, the vial pallet  27  acts as a positioning assembly to properly position the contemplated connection within the sterilizing field.  
      The electron beam tubes of the vial/device sterilization booth  270  are preferably continuously emitting. However, the emitting electron beam tubes are shielded from the connection area until the components are properly positioned to make a connection within a sterilizing field. The shielding is generally performed by the shutters  294 , 296 .  
      Referring again to  FIG. 35 , within the sterilization chamber  272 , the vial pallet  27  is positioned between the two electron beam sources. At this time, the shutters  294 ,  296  are in a closed position. In the present embodiment, the shutters  294 ,  296  are liquid cooled steel panels used to block the electron beam window before and after component sterilization and connection. The boustrophedonically arranged coolant flow preferably travels through the hollow upper and lower portion of the shutters  294 ,  296 . However, as with the sterilization booth housing, it is necessary that the shutters  294 ,  296  are dense enough to provide proper shielding, so the coolant flow (which require hollowing of the panel) is preferably absent from a central portion of the shutters where direct incidence of the electron beam is realized.  
      After proper positioning of the vial pallet  27  within the sterilization chamber  272  the vial back-up mechanism  307  is actuated, as shown in  FIG. 35A . The vial back-up mechanism  307  generally descends onto the vial holder  54  until the vial holder shield  312  has been positioned such that it forms a continuous radiation shield with the end plates  60  and side plates  64  of the vial holder  54 . The descending vial back-up mechanism  307  also moves the vial positioning tool  314  into contact with the vials  14 . The vials  14  are pushed downward into a connecting position. The vial back-up mechanism  307  and vial positioning tool  314  then stop and maintain that position until after the connection between the vial  14  and reconstitution device  10  has been made. The vial back-up mechanism  307  can be programmed to move and position the vial  14  as desired closing the exposure process.  
      The shutters  294 ,  296  are generally attached to the pneumatic actuator  302 ,  304  which is responsive to a controller (not shown). When the chamber doors are in a closed position ( FIG. 35 ), the appropriate controller can activate the pneumatic actuators  302 ,  304  to raise the shutters  294 ,  296  ( FIG. 35A ). At this point, component exposure is controlled by the position of the components within the resulting electron cloud (preferably within the electron flood area) as well as the time of exposure (i.e., the time the shutters are raised).  
      Once an appropriate level of exposure has been administered to ensure sterility of the desired portions of the drug vial  14  and the reconstitution device  10 , the snap-closure mechanism  320  is actuated. Referring to  FIG. 36 , the four independent pneumatic cylinders  324  of the snap-closure mechanism extend upward to the device holder subassembly  35  of the vial pallet  27  and move the device nests  48  upward until the reconstitution device  10  and vial  14  snap together within the flood area  658 . Each of the independent pneumatic cylinders preferably includes an electronic position feedback sensor  326  which monitors the cylinder position. Two parameters, including a linear cylinder monitor and a built in linear encoder, are generally used to apply the correct force to achieve a successful snap fit between the components. Load cells may be used to set the parameters for consistently effecting a snap closure as is well understood in the art.  
      It is understood that the vial  14  may have two positions within the vial holder  54 . In one preferred embodiment, the vial  14  may be repositioned one time during exposure in the sterilization field to better control any potential stray sterilization dose to the vial  14 . As shown in  FIG. 35 , the vial  14  can be moved within the vial holder  54  during the process if desired. As can be understood, the vial  14  has a generally flat surface (i.e., generally proximate the target area of the closure of the vial) requiring sterilization. The structure of the device  10  requiring sterilization, generally proximate the septum at the gripper assembly as shown in  FIGS. 2 and 2 A, has varying depths. As opposed to a generally flat surface, the structure having varying depths may require additional exposure time in the sterilization field to assure appropriate sterility. With a flat surface, the vial  14  may not need the same amount of exposure time to assure appropriate sterility. Accordingly, as discussed above, the vial  14  may be placed at a higher position within the vial holder  54  such that when the shutters  294 , 296  move to expose the sterilization field, the vial  14  initially experiences less dose during the exposure process. This enhances the control of the amount of dose the vial  14  experiences during the process. When it is time to connect, the vial  14  can be repositioned one time during the exposure and then connected to the device  10 . This provides better overall control of the dose exposed to the vial  14 . As is understood, the initial position of the vial  14  in the vial holder  54  can be varied and movement controlled as desired to enhance the sterile connection process.  
      Preferably, the sterile connection of a container and a reconstitution device is verified through the use of a dosimeter positioned on a pallet such that the dosimeter measures or approximates the dose of radiation incident upon the connecting components. Generally, a sterility assurance level (SAL), defined as a measure of the probability that one unit in a batch will remain non-sterile after being exposed to a specific sterilant, is selected. A dosage that will provide the desired sterility assurance level is then determined. By implementing a verification of sterility process, wherein the dosimeter on selected pallets passing through a sterilization booth is examined to validate a proper dosage of radiation, the desired sterility can be ensured. Such a process is described in detail in commonly-owned U.S. application Ser. No. ______ (Attorney Docket No. DDR-6609 (1417G P 844)), entitled “Method And Apparatus For Validation Of Sterilization Process,” filed concurrently herewith, which application has been previously discussed and incorporated by reference into this specification.  
      After a snap fit has been made between the vial  14  and the reconstitution device  10 , the shutters  294 ,  296  preferably close similar to their initial position as shown in  FIG. 35 . The pneumatic cylinders  324  also withdraw from the vial pallet  27 . The springs  44  within the device holder subassemblies  35  of the vial pallet  27  then preferably move the device nest  48  back to its original position within each of the device holder subassemblies  35 . In addition, the vial back-up mechanism  307  retracts to its original position. The reconstitution device  10  remains connected to the vial  14  as shown in  FIG. 10 . When connected, the vial  14  is positioned within the gripper assembly of the reconstitution device  10  to form the reconstitution device/vial subassembly  349 . The vial pallet  27  is then generally moved out of the sterilization chamber  272  and another vial pallet  27  moved in.  
      As generally discussed above, each of the pre-sterilization chambers  274 ,  521 , post sterilization chambers  276 ,  523  and sterilization chambers  272 ,  522  of the sterilization booths  270 , 520 , preferably includes its own independent conveyor. The movement of pallets through the three chambered sterilization booths  270 ,  520  is generally the same for both the vial/device sterilization booth  270  and the bag/device sterilization booth  520 , and will be described generally here.  
      Referring now to FIGS.  61 A-C, one example of the movement of a pallet  630  through a three chambered booth  632  according to the present invention can be generically understood. Beginning with a booth having a leading pallet  630  already in a middle, sterilization chamber  634 ,  FIG. 61A  shows the opening of a first door  636  into a pre-sterilization chamber  638 . A second pallet  630 ′ is conveyed into the pre-sterilization chamber  638 , and held until the first door  636  into the pre-sterilization chamber  638  is again closed. At this time, the lead pallet  630  in the sterilization chamber  634  is subject to sterile connection of component containers and reconstitution devices.  
      Then, as shown in  FIG. 61B , both a second door  640  between the pre-sterilization chamber  638  and the sterilization chamber  634 , and a third door  642  between the sterilization chamber  634  and a post-sterilization chamber  644  are opened. The lead pallet  630  is conveyed into the post-sterilization chamber  644 , while the second pallet  630 ′ is conveyed into the sterilization chamber  634  simultaneously. Then, both the second door  640 , and the third door  642  close.  
      Next, as shown in  FIG. 61C , the first door  636  into the pre-sterilization booth  638 , and a fourth door  646  out of the post-sterilization chamber  644 , open. The lead pallet  630  exits the post-sterilization chamber  644 , and a third pallet  630 ″ is introduced into the pre-sterilization chamber  638 . At this point the doors generally close. Now all of the doors are closed. The lead pallet  630  has completely exited the booth  632 , the second pallet  630 ′ is in the sterilization chamber  634  undergoing the sterile connect process. The third pallet  630 ″ is now located in the pre-sterilization chamber  638 . The sequence is then repeated from the opening of the doors  640 ,  642  leading into and out of the sterilization chamber  634 . Following such a progression maintains a sealed door on either side of the electron source at all times, thereby providing a full-time barrier against the escape of stray radiation from the sterilization chamber. Naturally, other sequences may be devised and safety features added to achieve this important safety precaution.  
      Movement of the pallets is controlled by the three independent conveyor surfaces of the pre-sterilization chamber  636 , sterilization chamber  634 , and post sterilization chamber  644 . The pre-sterilization conveyor surface is responsible for receiving a pallet from the system and transporting the pallet into the pre-sterilization chamber  636 . The pre-sterilization conveyor surface and the sterilization chamber conveyor surface work together to transport the pallet into the sterilization chamber. After sterilization, the sterilization chamber conveyor surface and the post sterilization conveyor surface cooperate to position the pallet within the post-sterilization chamber. Finally, the post sterilization conveyor surface transports the pallet to the system  21  for resumed handling. With alternate indexing through the chambers, variations on the number of conveyor surfaces used may be made. Those skilled in the art will understand how to correlate the indexing of pallets to the movement of the conveyor surfaces should variations be necessary.  
      Upon exiting the sterilization booth  270  ( FIG. 3 ), the vial pallet transfer assembly  90  conveys the vial pallet  27  to the vial holder removal module  340 . A soft stop  592  positions the vial pallet  27  at the vial holder removal module  340 . The vial holder  54  is lifted off of the top holder supports  36  by the pick and place unit  344  and the lift and locate unit  346 . As shown in  FIG. 40 , the vial pallet  27  is then returned to the unstacked loading position wherein the vial holder  54  is atop the container holder supports  50 . The reconstitution device/vial subassembly  349  is preferably retained in the vial holder  54  portion of the vial pallet  27 . The container holder supports  50  are preferably tall enough to insure the reconstitution device  10  does not contact the vial pallet base  29  when the vial pallet  27  is returned to the unstacked loading position.  
      The vial pallet transport assembly  90  then generally conveys the vial pallet to the depalletize device and vial module  350 , as shown in  FIG. 42 . The pallet lift and release mechanism  350  generally first lifts the vial pallet  27 . Then the transfer robot  354  generally grasps the four reconstitution device/vial subassemblies  349 . The pallet lift and release mechanism  350  then preferably opens the vial holder  54  portion of the vial pallet  27 , and the reconstitution device/vial subassemblies  349  are lifted clear of the vial holder  54  by the transfer robot  354 . The transfer robot  354  then deposits the reconstitution device/vial subassemblies  349  into the pucks  370  of the shrinkband applicator  360 . The unloaded vial pallets  27  then proceed along the vial pallet transfer assembly  90  to begin another cycle through the first cell  23  of the apparatus  21 . A plurality of vial pallets  27  generally circulate through the apparatus  21  simultaneously.  
      As shown in  FIGS. 43-44 , the reconstitution device/vial subassemblies  349  in the pucks  370  are then moved through the shrinkbanding process. The process is preferably fully automated, and generally includes placing a shrinkband ring over the sterilely connected vial and reconstitution device at the shrinkband application station  365  so that the shrinkband covers the connected portions as generally shown in  FIG. 2A . The pucks  370  then generally move along the free puck conveyor  368  through the oven  367 . The heat from the oven preferably shrinks the shrinkband ring so that it forms to the contours of a portion of the reconstitution device/vial subassembly  349 .  
      The pucks  370  exit the oven  367  and proceed to the palletize device and vial subassembly station  448  of the bag/device subassembly connection system  25  as shown in  FIG. 51 . The bag pallet  402  is preferably already loaded with a bag  16  upon arrival at the palletize device and vial subassembly station  448 .  
      Operation of Bag/Device Subassembly Connection System  25  (Second Cell)  
      Referring to  FIGS. 45-46 , the loading of bags  12  onto the bag pallet  402  is generally performed by operators using a bag pallet opener  488  ( FIG. 3 ) to open the bag gripper  420 . The operator then generally loads bags  12  onto the bag pallet  402  ( FIG. 45 ). In some embodiments, loading of the bags  12  may be an automated process performed by robots.  
      Loading of the reconstitution device/vial subassemblies  349  onto the bag pallet  402  is generally an automated process. The bag pallet conveyor assembly  444  generally transports the bag pallet  402  to the palletize device/vial subassembly module  448 , as illustrated in  FIG. 52 . A soft stop  602  ( FIG. 3 ) generally properly positions the bag pallet  402 . The transfer robot  452  of  FIG. 51  then removes the shrinkbanded reconstitution device/vial subassemblies  349  from the pucks  370  and loads them onto a bag pallet  402 . The pallet release mechanism  464  of  FIG. 52  opens the vial and device subassembly holder  408  on the bag pallet  402  so that the subassembly  349  can be loaded.  
      The fully loaded bag pallet  402  is then conveyed by the bag pallet transport assembly  444  to the nozzle blow-off module  500  of  FIG. 53 . A soft stop  604  ( FIG. 3 ) generally properly positions the bag pallet  402  within the nozzle blow-off station  500 . At the nozzle blow-off station  500 , any water droplets or loose particulate matter is blown off of the port connector  30  of the bag  12  before it enters the bag/device subassembly sterilization booth  520 .  
      From the nozzle blow-off module  500  the loaded bag pallet  402  is transported into the bag/device sterilization booth  520 , the operation of which is generally described below with the understanding that the operation is similar to the vial/device sterilization booth  270  described above.  
      The bag pallet  402  also acts as a positioning assembly to properly position the bag  12  and the reconstitution device/vial subassembly  349  such that the bag port connector  30  and the reconstitution device  10  are positioned within the flood area created by the electron beam emitters of the bag/device sterilization booth  520  ( FIG. 3 ) prior to the contemplated connection between these components. The rear shielding plate  426  of the bag pallet  402  generally has a window  434  formed in it to allow exposure of the bag port connector  30  and the reconstitution device sleeve connector port  17  to the flood area from the rear. The front portion of the bag pallet  402  generally has no built in shielding. Shielding of the front portion is accomplished by the heat shield  548  of the bag/device sterilization booth  520 , as shown in  FIG. 55 . The heat shield  548  generally includes the upper plate  550  and the lower plate  552 . As previously discussed, the lower plate  552  is preferably movable up and down vertically. When the lower plate  552  is moved down, a window exists between the plates which preferably corresponds to the positioning of the bag port connector  30  and sleeve connector port  17  when a bag pallet  402  is positioned for performing a sterile connection within the sterilization chamber  552 .  
      The sterilization chamber  552  of the bag/device sterilization booth  520  is different from that of the vial/device sterilization booth  270  because it does not include a vial back-up mechanism. The device/vial subassembly  349  is immovably secured by the device and vial subassembly gripper. It holds the device/vial subassembly  349  stationary while the bag  12  is preferably moved upward wherein the port connector assembly on the bag  12  is snap fit to the sleeve assembly of the reconstitution device  10 .  
      Referring to  FIGS. 55 and 56 , the bag  12  is generally positioned within the bag pallet  402  in the sterilization chamber  522 . After the bag pallet  402  is properly positioned in the sterilization chamber  522 , the shutters  532 ,  534  are moved upward creating a flood area which preferably encompasses both the port connector assembly  30  and the sleeve assembly  17 . The snap closure mechanism  558  is then actuated and its four pneumatic cylinders  562  move upward from a first loading position, pushing the bag back support plate  436  ( FIG. 46 ) and the bag  12  secured to it upward until it forms a snap connection with the stationary reconstitution device  10  at a second connecting position (i.e., the port connector assembly  30  snap fits into the portion  17  of the sleeve assembly of the device  10 ). It is understood that this connection is also made in a concentrated sterilizing field as shown in  FIGS. 62-64 . Once connected, a reconstitution assembly  1  is formed. Preferably, the sterile connection of a bag and a reconstitution device is verified through the use of a dosimeter positioned on a pallet such that the dosimeter measures or approximates the dose of radiation incident upon the connecting components. Generally, a sterility assurance level (SAL), defined as a measure of the probability that one unit in a batch will remain non-sterile after being exposed to a specific sterilant, is selected. A dosage that will provide the desired sterility assurance level is then determined. By implementing a verification of sterility process, wherein the dosimeter on selected pallets passing through a sterilization booth is examined to validate a proper dosage of radiation, the desired sterility can be ensured.  
      As in the vial/device sterilization booth  270 , two parameters, including a linear cylinder monitor and a built in linear encoder, are generally used to apply the correct force to achieve a successful snap fit between the components. After the bag  12  and reconstitution device  10  have been connected, the pneumatic cylinders  562  preferably move downward returning to the first loading position. The bag pallet  402  is then generally moved out of the sterilization chamber  520 .  
      Upon exiting the sterilization booth  520 , the bag pallet transfer assembly  444  conveys the bag pallet  402  to a bag reject station  606 . At the bag reject station  606 , either an operator or an automated bag inspection assembly  608  preferably inspects the fully assembled reconstitution assemblies  1 . Reject assemblies are removed from the bag pallet  402 .  
      From the bag reject station  606 , the bag pallet transfer assembly  444  conveys good parts to the depalletize reconstitution device assembly  568  as shown in  FIGS. 59 and 60 . A soft stop  606  as shown in  FIG. 3  generally positions the bag pallet  402  at the depalletize reconstitution device assembly  568 . The pick and place assembly  572  in conjunction with the pallet release mechanism then generally removes the reconstitution device assemblies  10  from the bag pallet  402  and places them on a belt conveyor  584 . The unloaded bag pallets  402  then proceed along the bag pallet transfer assembly  444  to begin another cycle through the second cell  25  of the system  21 . Preferably, a plurality of bag pallets  406  move through the apparatus  21  simultaneously. It is also understood that a plurality of vial pallets  27  move through the apparatus  21  simultaneously.  
      While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection is only limited by the scope of the accompanying claims.