Patent Publication Number: US-6655759-B2

Title: Container assembly for use with a rapid transfer port

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to rapid transfer port (RTP) systems for transferring articles between two environments (such as an isolator barrier system and a transfer container) that are adapted to be brought into close proximity to one another by a docking operation. More particularly, the present invention relates to a container assembly for use with an RTP of the type that requires rotation of the device being attached thereto. The container assembly has an enclosure that, during docking, is not required to be rotated. 
     2. Description of the Related Art 
     Certain manufacturing processes require the maintenance of separation between two environments to avoid contamination of the cleaner of the two environments by the dirtier of the two. This is accomplished with the use of environments such as isolation barriers. For example, in the case of certain pharmaceutical products, the manufacturing process is performed within these isolation barriers to prevent contamination of the product being produced by dust particles, bacteria and viruses which are found in the outside ambient air. The same holds true for the assembly of certain medical devices. In the case of radioactive operations or bacteriological procedures, the environment within the isolation barrier is dirty as compared to the outside ambient air. In these cases, the isolation barrier serves the function of keeping the product being handled from escaping into the external environment. 
     In recent years, in the pharmaceutical industry, because of the expense and operational difficulties of maintaining so-called “clean rooms” into which operators enter to carry out procedures, the use of isolation barriers has become common practice. The isolation barriers, in concept large glove boxes, are integrated onto the machinery used to carry out the necessary manufacturing operations. A variation of these isolation barriers is what is commonly known as a RABS, Restricted Access Barrier System. 
     Means for transferring components, product, supplies, etc. into and out of these isolation barriers without risk of contamination of the components being transferred by the “dirty” external environment during the docking and components transfer process must be provided. To accomplish this, isolator barrier systems and RABS feature devices generally called Rapid Transfer Ports (RTP). These RTP devices may be of various type, size and configuration. A common type of RTP device is one that is offered by the French company La Calhene, referred to as the DPTE. This device requires rotation of the transfer container during the docking process. This type of RTP device is generally mounted on an outer surface of the isolation barrier and features docking attachments for a pre-sterilized transfer container housing the components to be transferred. Upon the docking process, the operator places the transfer container into alignment with the RTP and rotates the container approximately 60 degrees to complete the docking operation. The docking process firmly attaches the transfer container to the RTP and, simultaneously, the transfer container door to the RTP door. Once docked, the operator reaches inside the isolation barrier via gloves located on the isolation barrier wall and opens the RTP door, with it attached the transfer container door, and gains access to the components located within the transfer container. To prevent contamination of the “clean” environment, the docking process places the “dirty” surfaces of the RTP and of the transfer container in sealed contact with each other thus not permitting “dirty” particles to escape into the “clean” environment. 
     The rotation necessary to dock the transfer container onto an RTP causes tumbling action of the components which are contained within the transfer container. This tumbling action may be acceptable when transferring soft plastic components such as stoppers or cleaning supplies but it is undesirable, if not prohibitive, when transferring heavy, delicate machine components. In addition, the rotation of the container upon docking does not permit interface of the container to a lifting device such as a hoist or crane. Such lifting operation may be necessary to meet the manufacturing requirements of some products. 
     SUMMARY 
     The present invention is a container assembly for use with a rapid transfer port. The rapid transfer port (RTP) is of the type having an RTP door, an RTP circular seal around the door, and spaced RTP indentations. The RTP requires rotation of the device being attached thereto. The container assembly includes a circular ring member having an interface end and a bearing system end. The interface end includes a first set of ring member protrusions for engagement with RTP indentations of an RTP and a container assembly circular seal for providing sealing engagement of the ring member and the RTP. A circular enclosure door is concentrically positioned within the ring member. The enclosure door includes a first set of enclosure door indentations for engaging associated RTP door protrusions and a second set of enclosure door indentations for engaging a second set of ring member protrusions. The container assembly circular seal further provides sealing engagement of the ring member and the enclosure door. A bearing system is engaged with the bearing system end of the ring member. An enclosure having a bearing system engagement portion is engaged with the bearing system wherein the bearing system provides relative rotation of the ring member and the enclosure about a central axis of the ring member. The enclosure further includes an enclosure seal operatively engaged with the ring member for providing a sealing engagement between the enclosure and the ring member. The ring member provides the rotation required for proper attachment of the container assembly to the RTP without any requirement for rotation of the enclosure. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an end view of the container assembly of the present invention. 
     FIG. 2 is a cross-sectional view of the container assembly shown along line  2 — 2  of FIG.  1  and docked to an RTP system shown in phantom. 
     FIG. 3 is a partial cross-sectional view of the container assembly, showing a roller assembly that provides radial positioning. 
     FIG. 4 is a partial cross-sectional view of the container assembly, showing a roller assembly that provides axial positioning. 
     FIG. 5 is a partial cross-sectional view of the container assembly, showing an alternate bearing system consisting of ball bearings. 
     FIG. 6 is a partial cross-sectional view of the container assembly, showing another alternate bearing system consisting of a sliding member. 
     Other objects, advantages, and novel features will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to the drawings and the characters of reference marked thereon, FIGS. 1-4 illustrate a preferred embodiment of the present invention, designated generally as  10 . The container assembly  10  includes a circular ring member, designated generally as  12 . The ring member  12  has an interface end  14  and a bearing system end  16 . The interface end  14  includes a first set of ring member protrusions  18  for engagement with RTP indentations  20  of an RTP, designated generally as  22 . The RTP  22 , shown in phantom in FIG. 2, may be such as that manufactured by the French company, la Calhene, referred to in the industry as “DPTE.” The first set of ring member protrusions  18  may be integral parts of ring member  12  or separate parts that are attached to ring member  12  by means of suitable fasteners. 
     The RTP  22  shown in FIG. 2 is very similar to that disclosed in U.S. Pat. No. 5,460,439, issued to Jennrich et al and hereby incorporated by reference. U.S. Pat. No. 3,289,698, issued to Cazalis et al, also discloses an RTP port configuration and is hereby incorporated by reference. The RTP ports in both of these patents require rotation of the container assembly upon docking. 
     The ring member  12  includes a container assembly circular seal  24  for providing sealing engagement of the ring member  12  and the RTP  22 . The circular seal  24  may be, for example, what is known in this industry as a “Beta Seal” that is commercially available. This seal has two contact surfaces on two of its faces and two extensions that engage the seal  24  to the other portions of the ring member  12 . It may typically be formed of silicon or Viton™. The seal  24  snaps into a groove  26 , as can be seen most clearly in FIGS. 3 and 4. 
     A circular enclosure door, designated generally as  28 , is concentrically positioned within the ring member  12 . The enclosure door  28  includes a first set of enclosure door indentations  30  for engaging associated RTP door protrusions  32 . The enclosure door  28  includes a tapered outer surface  34  that provides a sealing engagement with an associated surface of the circular seal  24 . A second set of enclosure door indentations  36  engage a second set of ring member protrusions  38 . The second set of ring member protrusions  38  may be integral parts of the ring member  12  or separate parts that are attached to ring member  12  by means of suitable fasteners. The ring member  12  and enclosure door  28  are typically formed of a metal such as aluminum alloy. 
     A bearing system of the container assembly  10  engages with the bearing system end  16  of the ring member  12 . Referring now specifically to FIG. 3, the bearing system includes a first set of circumferentially spaced roller assemblies, designated generally as  40 . Each roller assembly  40  of this first set is attached to the bearing system end  16  of the ring member  12 . This attachment is provided by an associated mount or bracket  42  that is attached to the bearing system end  16  by suitable fasteners such as bolts (not shown). The roller assembly  40  includes a round shaft  44  fastened to mount  42 . A plastic bushing  46  is pressed into a metallic roller  48  and rotates freely on shaft  44 . This provides radial positioning of the enclosure as described in detail below. 
     Referring now specifically to FIG. 4, the bearing system also includes a second set of circumferentially spaced roller assemblies designated generally as  50 . As with the first set, each roller assembly  50  of this second set is attached to the bearing system end  16  of the ring member  12 . Such attachment is provided by associated mounts or brackets  52 , attached to the bearing system end  16  by suitable fasteners. The roller assembly  50  may be designed the same as the roller assembly  40 , with the shaft  54 , bushing  56  and roller  58 . 
     An enclosure  60  includes a bearing system engagement portion comprising an axially oriented bearing surface  62  (seen in FIG. 3) and a radially oriented bearing surface  64  (seen in FIG.  4 ). The radially oriented bearing surface  64  is obtained by machining a groove  66  in a forward section  68  of the enclosure  60 . 
     The enclosure  60  includes an enclosure seal, designated generally as  70 . The enclosure seal includes an o-ring  72  positioned in a ring member facing groove  74  of the enclosure  60 . A sliding element  76  is positioned between the o-ring  72  and a portion  78  of a surface of the bearing system end  16  of the ring member  12 . The o-ring  72  provides a compressive force on the sliding element  76  that is transferred onto the ring member  12 . The sliding element is preferably formed of Teflon®. The enclosure  60  includes the forward section  68  and a main section  80 . The main section  80  may be attached to the forward section  68  by suitable circumferentially spaced fasteners  81  and an o-ring  83 . The main section  80  may take different forms depending upon the desired application; however, a specific embodiment will be described below for the purposes of illustration and not limitation. A shuttle assembly, designated as  82  is fastened to a surface of the main section  80  for the purpose of safe transport and handling of internal components. A lifting interface element, designated generally as  84 , is permanently attached to the main section  80  for the purpose of safely lifting and transporting the container assembly  10 . A support hook device  86  is attached to the lifting interface element  84  for supporting the weight of the container assembly  10  during docking with the RTP  22 . The support hook device  86  also functions as an anti-rotation element that prevents rotation of the enclosure  60  relative to RTP  22 . Lifting handles  88  are permanently attached along the sides of the main section  80  for safely lifting and carrying the container assembly  10 . 
     The container assembly  10  provides the ability to transfer parts contained within the environment of enclosure  60  to another enclosure such as an isolator barrier system or RABS that has an RTP. The external surfaces of the container assembly  10  and RTP  22  are considered to be contaminated. Therefore, transfer of such parts between the two environments must take place without contacting such outer surfaces. When the container assembly  10  is connected to the RTP  22 , all contaminated surfaces are maintained in close contact with each other, including the outer surfaces of the RTP door  94  and the enclosure door  28 . This close contact prevents contact of the sterile components with the contaminated surfaces. 
     During use, the operator, using lifting handles  88 , positions the container assembly  10  such that the support hook device  86  engages a mating element  90  of the RTP  22 . The operator then assures proper engagement of the container assembly  10  with the RTP  22 . The operator then turns ring member  12  using turning handles  92 . This turning provides engagement of ring member protrusions  18  with RTP indentations  20  and enclosure door indentations  36  with ring member protrusions  38 . During this process, the circular seal  24  remains in contact with RTP  22 . However, during this rotation, the enclosure  60  is prevented from rotating by the engagement of support hook  86  and a mating element or cradle  90  of the RTP  22 . Although a particular mating element  90  has been shown, this showing is by way of illustration and not limitation. Obviously, other types of mating elements can be used. For example, pin elements or blades or other suitable anti-rotation means can be similarly utilized. Once the required rotation is achieved, the operator actuates a latching device (not shown) on the RTP  22  to open the RTP door  94 . The RTP door  94  and the enclosure door  28  open as an integral unit permitting access to any components within the enclosure  60 . To facilitate rotation of the ring member  12  in the RTP  22 , a set of axially oriented and radially oriented anti-friction rollers  96  are fixed to the ring member protrusions  18 . 
     Once the enclosure door  28  has been opened, the operator may access the shuttle assembly  82 , pulling it in or out for retrieving or replacing components on the shuttle tray  98 . After the retrieving or the placing of components has been accomplished, the operator can close the enclosure door  28  (along with the RTP door  94 ) and turn the ring member  12 , using handles  92 , for disengaging the container assembly  10  from the RTP  22 . Then, the container assembly  10  can be disengaged and can be transported using lifting handles  88 . 
     FIG. 5 shows an alternate embodiment of the bearing system. A first set of circumferentially located ball bearings  100  are positioned in a ring member  12  facing groove  99  of enclosure  60  and are in operative engagement with a radially oriented portion  110  of a surface of the bearing system end  16  of ring member  12  and a radially oriented surface  108  of groove  99 . A second set of circumferentially located ball bearings  106  are positioned in a cavity formed by the proximity of ring member  12  and enclosure  60  and are in operative engagement with a radially oriented surface  114  of enclosure  60  and a radially oriented surface  112  of ring member  12  and with an axially oriented surface  104  of enclosure  60  and an axially oriented surface  102  of ring member  12 . 
     FIG. 6 shows a third embodiment of the bearing system. A circular sliding member  116  provides both axial and radial positioning of ring member  12  relative to enclosure  60 . To maintain axial positioning of ring member  12  relative to enclosure  60 , the sliding member  116  is in operative engagement with a radially oriented portion  118  of a surface of the bearing system end  16  of ring member  12  and the corresponding radially oriented surface  126  of enclosure  60 , with a radially oriented surface  120  of ring member  12  and a corresponding radially oriented surface  128  of enclosure  60 . To maintain radial positioning of ring member  12  relative to enclosure  60 , the sliding member  116  is in operative engagement with an axially oriented surface  122  of ring member  12  and an axially oriented surface  124  of enclosure  60 . 
     Although the invention here described is directed mostly for use in the pharmaceutical industry, it is understood that it is equally applicable to the nuclear industry, the medical devices industry, and any other industry requiring transfer of materials through a barrier wall without intermingling of the environments on opposite sides of the barrier wall. 
     Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.