MXPA99007180A - System for transferring objects into barrier isolator - Google Patents

Abstract

A transfer system (10) for transferring objects (14) into a barrier isolator (12) with a barrier wall (20) having a port opening (28) includes a first port barrier film (40) sealingly located over the port opening (28). A container (50) with an interior cavity (52) holding decontaminated objects (14) is sealed with a container barrier film (60). A parting and sealing element (76) located within the barrier isolator (12) parts the first port barrier film (40) and the container barrier film (60) and simultaneously seals together and decontaminates the edges of the first port and container barrier films (40, 60) to define a transfer opening for the decontaminated objects (14) to pass into the barrier isolator (12).

Description

SYSTEM TO TRANSFER OBJECTS IN A BARRIER ISOLATOR BACKGROUND OF THE INVENTION The present invention relates to isolated rooms and / or equipment for maintaining an aseptic environment, and in particular, to a system for transferring sterile objects in said isolated space. In the past, the production and handling of certain products, such as pharmaceuticals, was carried out in a clean room to avoid contamination of the product during processing. The clean room was maintained as an isolated and aseptic area and the equipment or other objects that entered the isolated area, such as consumables used during the processing of said products, had to be sterilized before being introduced into the aseptic environment. In addition, the personnel who worked in these rooms had to wear protective clothing to avoid contamination of the area. Recently, to reduce the costs associated with running a clean room, insulated equipment has been introduced by a barrier that maintains a local aseptic environment directly around the processing equipment for certain types of products. The equipment is accessed through glove portals and the objects are sterilized and transferred in the isolated area by air insurance. Objects that are introduced into the isolated area can be presterilized or sterilized within the air lock before being introduced into the isolated area by barrier. Generally, each machine or isolated area would require an air insurance or treatment container to receive the items that will be sterilized, such as cover elements for pharmaceutical containers. The cover elements are then sterilized inside the treatment vessel before being passed to the isolated system. It would be desirable to reduce the time required and the cost involved to sterilize parts or other materials that will be introduced into an isolated system in place. A solution to this problem, which is described in the US patent. No. 5,447,699, which was jointly invented by the present inventor and is assigned to the assignee of the present invention, provides a. container in combination for retaining sterile items such as bottle caps and a sterilizable transfer port for transferring the sterilized items to the isolation system. However, the exposed areas of the transfer port components still have to be sterilized in place before the transfer of elements into the isolation system. This arrangement allows the required elements to be sterilized in a different location before being shipped to a processing and packaging company where the sterilized elements are fed into the isolation system, such as a system for bottling pharmaceutical products.

BRIEF DESCRIPTION OF THE INVENTION Briefly mentioned, the present invention provides a transfer system for transferring objects in a barrier insulator. The barrier insulator includes a barrier wall to maintain a decontaminated environment in an isolated environment. The transfer system includes a port opening located in the barrier wall to provide access to the isolated space. A first port barrier film is loosely seated over the port opening. The first barrier film of the port has a first decontaminated side that faces towards the isolated space and a second side that gives away from the isolated space. A container is provided which includes an interior cavity containing a second replacement port barrier film and which is adapted to receive and retain also decontaminated objects that will be delivered through the port opening and into the insulated space. A container barrier film is sealingly connected to the container for sealing the second replacement port barrier film and the decontaminated objects within the cavity in a decontaminated state. The container barrier film has a first decontaminated side facing the cavity, and a second exposed side that can be placed adjacent to the port barrier film. A separating and sealing element is located within the insulated space adjacent to the port opening, and is mounted to move to a position in use adjacent to the first side of the first port barrier film. The separation and sealing element is adapted to separate the first port barrier film and the container barrier film to define a transfer opening having edges on the first port barrier film and the container barrier film and for simultaneously sealing and decontaminating the edges of the first port barrier film and the container barrier film so that the exposed and potentially contaminated second sides of the first port barrier film and the container barrier film are locked together and remain isolated from the isolated space. This allows the decontaminated objects and the second replacement port barrier film to be passed out of the containment cavity, through the transfer opening and into the insulated space, at the same time keeping the environment decontaminated. In another aspect, the present invention provides a container for use in a transfer system for transferring objects in a barrier insulator, which includes a barrier wall for maintaining a decontaminated environment in an insulated space. The barrier insulator has a port opening with a first port barrier film that seals the port opening. The container includes a plurality of walls defining an interior cavity with an opening. A second replacement port barrier film is located in the cavity. The interior cavity is further adapted to hold objects that will be supplied with the second replacement port barrier film through the port opening and in the insulated space. A container barrier film is sealingly connected to the container to seal the cavity. In another aspect, the present invention provides a method for delivering decontaminated objects and a replacement port barrier film to a decontaminated environment in an isolated space bounded by a barrier wall. The method includes the steps of: (a) providing a port opening in the barrier wall and a first port barrier film sealing the port opening, the first port barrier film having a first decontaminated side facing the port isolated space to close the isolated space and a second exposed side; (b) placing a container adjacent to the port opening, the container having a decontaminated interior cavity with decontaminated objects and a second replacement port barrier film sealed within the cavity by a barrier film of container, the barrier film of container has a first decontaminated side and a second exposed side, the second side of the first port barrier film being in surface engagement with the second side of the container barrier film; (c) simultaneously creating a transfer aperture in the first port barrier film and the container barrier film and sealing the edges formed around the transfer aperture in the first port barrier film and in the film therethrough. container barrier with a separation and sealing element located within the insulated space; (d) transferring the decontaminated objects and the second replacement port barrier film from the container, through the transfer opening in the first port barrier film and in the container barrier film, and in the insulated space; and (e) releasing the port opening with the second replacement port barrier film, while maintaining the decontaminated environment in the isolated space.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS The above brief description, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the invention, modalities that are currently preferred are shown in the drawings. However, it should be understood that the invention is not limited to the precise arrangements and instrumentation shown. In the drawings: Figure 1 (a) - Figure 1 (f) are sequential side elevational views showing the operation of a transfer system for transferring objects in a barrier insulator in accordance with a first embodiment of the present invention; Figure 2 is a view taken along line 2-2 of Figure 1 (f); Figure 3 is an elongated cross-sectional view taken along line 3-3 of Figure 2, showing a container being placed adjacent to the port opening for transferring objects in the barrier insulator; Figure 4 is an elongated cross-sectional view similar to Figure 3, showing the separating and sealing element forming an opening in the barrier films; Fig. 5 is an elongated cross-sectional view similar to Fig. 3, showing the container opening for transferring objects in a barrier insulator; Figure 6 is an elongated cross-sectional view similar to Figure 3, showing the installation of a next port barrier in the port opening; Figure 7 is a partial elevation view of Figure 1 (a), illustrating a second embodiment of a transfer system for transferring objects in a barrier insulator; Figure 8 is a cross-sectional view taken along line 8-8 of Figure 7; Figures 9 (a) - 9 (e) are side elevational views in sequence showing the operation of a third embodiment of a transfer system for transferring objects in a barrier insulator in accordance with the present invention; Figure 10 is a view of the container and the attached port barrier film according to the third embodiment of the invention, taken along lines 10-10 of Figure 9 (e); Figure 11 is a cross-sectional view of the port and container barrier film according to the third embodiment of the invention, taken along lines 11-11 of Figure 10; and Figure 12 is a perspective view of the container according to the third embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION Some terminology is used in the following description solely for convenience and is not limiting. The words "right", "left", "lower" and "upper" designate directions in the drawings to which reference is made. The words "inward" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the transfer systems in accordance with the present invention for transferring objects in a barrier insulator 12 and designated portions thereof.

The terminology includes the words mentioned specifically above, derived from them and words of similar importance. Referring to the drawings, in which like numerals indicate like elements throughout the description, the transfer system 10 for transferring objects 14 in an insulator is shown in Fig. 1 (a) - Fig. 1 (f) barrier 12. In the preferred embodiment, the barrier insulator 12 is used to enclose equipment used in the bottling of pharmaceutical products in an aseptic environment, and preferably, the objects 14 are bottle caps which are directed by a channel 16 in a hopper 18 that feeds the stoppers to the bottling equipment. Barrier insulator 12 includes a barrier wall 20, more fully illustrated in transverse form in Fig. 1 (a), which maintains a decontaminated environment in an insulated space 22 enclosed by barrier wall 20. Barrier wall 20 it is preferably made of a waterproof material and can be configured to enclose a piece of equipment or a complete production line depending on the particular application. For the purposes of the present application, the barrier wall 20 is designed to refer to any partition member used to isolate an insulated space. Referring now to Figure 2, a port opening 23 is located in the barrier wall 20 to provide access to the insulated space 22. Preferably, the port opening 28 is surrounded by a reinforcement 30 shown in greater detail in FIG. Figure 3, which extends around an opening 32 in the barrier wall 20. The reinforcement 30 has a surface 34 that surrounds the port opening 28 and a predetermined depth. Preferably, a plurality of spaced annular seals 36 surrounding the port opening 28 are located on the surface 34. Preferably, the annular seals 36 are located in the miyan glue slots 38 in the surface 34 of the reinforcement 30. In In the preferred embodiment, at least two annular seals 36 are provided, and most preferably four annular seals are used. However, it will be recognized by those skilled in the art from the present disclosure that the reinforcement 30 may be formed integrally with the barrier wall 20, and does not need to be a separate part attached to an opening in the barrier wall.

. The annular seals 36 are preferably round in cross section, and project over the surface 34 from the dovetail grooves 38. However, it will be recognized by those skilled in the art from the present disclosure that other types of seals can be used. seals, if desired, such as fin or cam seals mounted directly to the surface 34 of the reinforcement 30. Referring to FIG. 3, a barrier port film 40 is sealably located on the port opening 28. Port barrier film 40 has a first decontaminated side 40a that faces the insulated space 22 and a second side 40b that is exposed.

Preferably, the port barrier film 40 is mounted on a frame 42 having an outer periphery 44 which is complementary and designed for adaptation with minimum tolerance with the port opening 28. The outer periphery 44 of the frame 42 is coupled in a manner sealable by at least one annular seal 36. The frame 42 is also slidably displaceable through the port opening 28 along the surface 34 while maintaining a sealed contact around the entire outer periphery of the frame 42 with one or more of the annular seals 36. In the preferred embodiment, the frame 42 is made of a polymeric material, such as polyethylene. However, it will be understood that the frame can be made of a metallic material or any other suitable impermeable material, if desired. Each frame 42 has a thickness to provide a desired stiffness, and the thickness is preferably 1.3 cm or more.

Preferably, the depth of the reinforcing surface 34 is greater than the thickness of the two frames 42 so that a first frame 42 can be displaced out of the opening while a second frame 42 'is sealably coupled by at least one annular seal 36 in the port opening 28 to maintain isolation from the insulated space 22 upon removal of the frame 42, as shown in detail in Figure 6, which will be explained in more detail below. Referring to Figures 1 (a) and 3, a container 50 is provided which is adapted to retain the objects 14 that will be delivered through the port opening 28 and in the insulated space 22. As shown in Figure 3 , the container 50 includes an interior cavity 52 adapted to receive decontaminated objects 14, and a rim 56 extending outwardly around the opening toward the interior cavity 52. The exterior 54 of the container is exposed during use. Preferably, the container 50 is made of a single piece of thermally formed polymeric material, and the rim 56 is formed integrally with the container 50. However, it will be recognized by those skilled in the art from the present disclosure that other materials are used to make the container 50 and that the container 50 can be made from more than one piece of material, if desired. Still with reference to Figure 3, in the first embodiment, a protector 58 is located on an inner periphery of the rim 56 of the container 50 to prevent the separation and sealing member 76 from acting on the rim 56, as explained in detail below. . The protector 58 is preferably a thin sheet of heat-resistant material, such as aluminum foil or other metallic foil which is attached to the surface of the flange 56. However, those skilled in the art will recognize from the present disclosure that the protector 58 can be omitted if the flange 56 itself is made of a suitable heat resistant material. A container barrier film 60 is coupled to an outer periphery of the rim 56 so that the decontaminated objects 14 are adapted to be sealed within the interior cavity 52 in the container 50 and remain decontaminated in the cavity 52. The barrier film of container 60 has a first decontaminated side 60a that faces cavity 52, and a second exposed side 60b that is exposed to outside air. Preferably, both container and port barrier films 40 and 60 are made of a polymeric material such as a polyethylene having a thickness of about 0.10 mm. The container barrier film 60 is preferably connected to the flange 56 by means of an adhesive or a heat-sealed connection between the outermost periphery of the container barrier film 60 and the flange 56. No connection is provided between the film barrier 60 container and protector58, and the barrier film 60 is releasable from the protector 58. The port barrier film 40 is attached to the port frame 42 in a similar manner. Referring now to Figures 1 (a) -1 (f) and Figure 3, a holder 64 is located adjacent to the port opening 28. The holder 64 preferably includes a hinge arm 66 that is connected to a support frame. 68 having a defined opening therethrough to receive the container 50, the flange being supported 56 of the container 50 on the frame 68. A locking mechanism 70, shown in Figures 1 (a) - 1 (f), is attached to the exterior of the barrier insulator 12 and includes a movable latch element that contacts the the support frame 68 for locking the container 50 in a position adjacent to the port opening 28, the second side 40b of the port barrier film 40 being in surface engagement with the second side 60b of the container barrier film 60 Preferably, the locking mechanism 70 includes a solenoid-operated latch 72 that is adapted to engage the container holder frame 68 to hold the container holder 64 in place. The solenoid operated mechanisms that are used as locking elements are generally known in the art. Consequently, it is not believed that a detailed description is necessary. Those skilled in the art will recognize from the present disclosure that any type of locking mechanism, such as a manually engaged bolt, may be used if desired to maintain the container holder 64 in position with the container. 50. It will be similarly recognized that the locking mechanism 70 can be omitted depending on the configuration and position of the container holder 64 and the container 50. For example, the combined weight of the container holder 64 and the container 50 is sufficient to maintain the container 50. in position. Referring now to Figures 1 (b), 1 (f), 2 and 4, a separating and sealing member 76 is located within the insulated space 22 adjacent to the port opening 28. The separation and sealing element 76 is mounted to a door assembly 78 for movement from a first position, shown in Figure 1 (b), to a second position in use adjacent to the first side 40a of the port barrier film 40, as shown in the figures 1 (f), 3 and 4. The separation and sealing element 76 is used to separate the port and container barrier films 40 and 60 as shown in Figure 5 to define a transfer opening 80 having edges 82. in the port and container barrier films 40 and 60. The separation and sealing element 76 is used to simultaneously seal each other and decontaminate the edges 82 of the port and container barrier films 40 and 60 so that the seconds sides 40b, 60b expuest and potentially contaminated from the port and container barrier films 40 and 60 are interlocked and remain insulated from the insulated space 22. Preferably, the separation and sealing element 76 is aligned with the covered area of the protector 58 of the container. flange 56, as shown in FIG. 4. Protector 58 is located on the flange to prevent barrier films 40 and 60 from adhering to a portion of flange 56 during the separation and sealing operation. It is also possible to align the separation and sealing element 76 along an inner edge of the rim 56, as shown in FIG. 8 in relation to the second embodiment of the invention, while using an external member (not shown) for applying external pressure to the container 50 to support during the separation of the barrier films 40 and 60 while simultaneously sealing and decontaminating the edges. In this case, protector 58 is also not required. As shown in detail in figure 5, preferably the separation and sealing element 76 is a heating element having an elevated portion 77 which is used to simultaneously separate the barrier films 40 and 60, seal the edges 82 together and decontaminate the edges 82 around the opening 80 to ensure that the isolated space is not contaminated. A preferred heating element is available from Toss Machine Components of Nazareth, Pennsylvania. As best shown in Figure 2, the separation and sealing element 76 extends around at least two, and preferably three sides of the rim 56 of the container 50, and is adapted to form a flap 85 from the barrier films of port and container 40 and 60. The edges 82 along both the flap 85 and the opening 80 are sealed and decontaminated simultaneously by the separation and sealing member 76. Referring now to Figure 2, the door assembly 78 is preferably connected to the wall 20 of the barrier insulator by the hinge 84 which allows the door assembly 78 to be folded down from a closed position, as shown in FIG. 1 (f) to an open position as shown in FIG. Figure 1 (b). As shown in Figures 2 and 4, the door assembly 78 includes an outer door frame 86 to which the first hinge 84 is connected. Preferably, an actuator 88 is connected between the barrier wall 20 and the outer frame 86 for open and close the door. The actuator 88 may be operated electrically or pneumatically, preferably from a remote location outside the insulated space 22. An opening 89 is provided in the outer door frame 86, and an inner door 90 is located in the opening 89. The inner door 90 it is supported by hinges 92, 94. Preferably, an actuator 96 is provided to move the inner door 90 relative to the outer door frame 86, as shown in Figure 1 (a). The separation and sealing element 76 is supported by the inner door 90. The inner door 90 also acts as a support for the flap 85, which moves between a first position, as shown in Figures 1 (f) and 4 , in which the inner door 90 is adapted to engage the flap 85 and maintain the flap 85 in a closed position, and a second position as shown in Figures 1 (a) and 5 in which the inner door moves outside the port opening 28, allowing the flap 85 to open. Referring now to Figures 1 (a) - 1 (f), once the sterilized objects 14 are transferred from the container into the insulated space 22, a new port frame 42 'with an uncut barrier film 40 is placed in the port opening 28 from inside the barrier insulator 12, and is sealingly coupled by annular seals 36 adjacent to the inner edge of the reinforcement 30. Preferably , a robot 100 with a arm 102 is used to load new port barrier frames 42 'into port opening 28. In figure 1 (a), arm 102 is shown in position to pick up a following port barrier frame from a reservoir 104 that contains additional frames 42 located within the barrier insulator 12. Referring to FIG. 6, preferably at least one solenoid-operated fastener 106 is mounted on the end of the robotic arm 102 to attach to the port 42 barrier frame. Preferably, at least two fasteners 106 are attached to the arm 102 and are moved inwardly or outwardly by an actuator 108 to hold the port barrier frame 42. Those skilled in the art will recognize from the present discle that they can be provided. other types of securing mechanisms on the end of the robotic arm 102 for securing the port barrier frames 42 and removing them from the tank 104 by moving them in position at port opening 28, and the present invention is not limited to the type of mechanism used. Once the container 50 has been emptied as shown in Fig. 1 (b), the inner door 90 is closed and the outer door frame 86 is opened by the actuator 88 to move the door assembly 78 away from the opening port 28. As shown in Figs. 1 (b) and 1 (c), the arm 102 is used to remove the next port barrier frame 42 'from the reservoir 104 and insert the next frame 42' into the port opening. Port 28. As shown in detail in Figure 6, the following port barrier frame 42 'is used to move the next port barrier frame 42 with the container 50 attached outside the port opening 28. The annular seals 36 prevent contamination of the insulated space 22. Preferably, a positive pressure is also maintained within the insulated space 22 to ensure that there is an outflow of air from the interior of the insulated space 22 through any space that could form during the insertion of the following port barrier frame 42 '.

As shown in Figure 1 (d), once the next port barrier frame 42 'is in position, the locking mechanism 70 is released so that the hinge arm 66 can be opened and the container 50 empty with the bonded port and container barrier films 40 and 60 can be removed and discarded. As the arm 102 is moved back to its starting position, a new container 50 'filled with sterilized objects that will be transferred to the barrier insulator 12 can be loaded into the container holder 64, as shown in FIG. 1 (FIG. and). The decontaminated objects 14 are supplied to the decontaminated environment in the insulated space 22 as described above, holding the container 50 or 50 'to the port opening 28. As shown in Figures 1 (f) and 3, the container 50 or 50 'is held in place by the locking mechanism 70, which holds the container holder 64 in position with the second side 60b of the container barrier film 60 located in surface engagement with the second side 40b of the barrier film port. The door assembly 78 is moved from the first position, shown more clearly in Figures 1 (b) and 1 (e), to the second position, shown in Figure 1 (f), for positioning the separation and sealing element. 76 adjacent to the first surface 40a of the port barrier film 40, as shown in Figure 4. Energy is supplied to the separation and sealing element 76 and pressure is applied by the inner door 90 so that the separation element and seal 76 simultaneously creates an opening 80 in the port and container barrier films 40 and 60 and seals together the edges 82 formed around the opening 80 in the port and container barrier films 40 and 60. The interior door 90 is then pivoted outwardly away from the barrier insulator wall 20 as shown in Fig. 1 (a) and acts as a support for the flap 85 created by the separation and sealing element 76, as shown in the fig. 5. The inner door 90 is used to position the flap 85 for controlled discharge and transfer of the decontaminated objects 14 from inside the container 50 through the transfer opening 80 in the port and container barrier films 40 and 60, and within the insulated space 22. The insulated space 22 within the barrier insulator 12 remains decontaminated or during transfer since the edges 82 around the opening 80 in the port and container barrier films 40 and 60 are sealed between yes. Once the contents of the container 50 have been transferred, the inner door 90 is closed, and the outer door frame 86 is opened inward, and the process is repeated. Referring now to Figure 7, a second embodiment of a transfer system 110 according to the present invention is shown. The second embodiment 110 is similar to the first embodiment, except that the port barrier film is provided as a pre-sterilized roll 140 of material, which is supplied through the port opening 28. As shown in Figures 7 and 8 , the pre-sterilized barrier film roll 140 is rotatably supported in a microbial annihilation housing 142 located adjacent to the port opening 28.

Preferably, the microbial annihilation housing 142 is a thermal box having heating elements 144 located therein adjacent to the pre-sterilized barrier film roll 140. The port barrier film 140 is slidably moved through the opening. port 28 and seals 151 are provided around the entire outer periphery of the port opening 23 that engage at least one surface of the port barrier film 140. The port and container barrier films 140 and 60 are separated and sealed by the separation and sealing element 176, which is similar to the separation and sealing element 76 described in relation to the first embodiment, in the same manner as previously described. However, the raised portion 177 of the separation and sealing element 176 is aligned along an inner edge of the rim 56 so that the protector 58 is not necessary. To remove the empty container 50 with the attached port barrier film 140, the empty container 50 with the bonded port barrier film is slidably displaced until the entire container 50 passes beyond the port opening 28 while removes additional barrier film material 140 from the roll through port opening 28. Seals 151 prevent contaminants from entering through port opening 28.

Although heat is the preferred form of operation for the separation and sealing member 176 to separate and seal the barrier films 40, 60, 140, other shapes may be used, if desired. For example, ultrasonic welding or cutting can be used to separate and seal the barrier films. It may be desirable or necessary in some alternative ways to provide complementary sterilization at the cut edges, such as by the use of ultraviolet light, germicides, etc. Referring now to Figures 9 (a) - 9 (e) and 10-12, a third embodiment 210 of a transfer system for transferring objects into a barrier isolator 212 is shown. The third embodiment is similar to the one described in FIG. first embodiment and similar elements have been identified with equal reference numbers that are 200 larger than the reference numbers of the first embodiment 10. For example, container 250 according to the third embodiment of transfer system 210 is similar to container 50 according to the first preferred embodiment 10 of the invention. Accordingly, a detailed description of these similar features has been omitted, and a detailed description of the differences between the first and third embodiments 10, 210 is given below. As shown in Figures 9 (a) - 9 (e), a port opening 228 is located in the barrier wall 220 to provide access to the insulated space 222. A first port barrier film 240, which is preferably mounted on a frame 242, is sealably located in the port opening 228 As in the first embodiment, the first port barrier film 228 has a first decontaminated side 240a that faces the insulated space 222, and a second side 240b that faces outside the insulated space 222, and is exposed. A similar annular seal system 236 located on a surface 234 of the port opening 228 is used to form a seal against the frame 242. As shown in Figures 9 (a) - 9 (e), and in detail in the 10-12, a container 250 having an inner cavity 252 is provided. A second port barrier film 240 ', which is also preferably mounted on a frame 242', is located in the container 250. Preferably, the frame 242 'of the second replacement port barrier film 240' has an outer periphery which is complementary to the port opening 228 so that the second port barrier film 240 'can be sealably coupled by at least one seal annular 236 in the port opening 228 while slidably installed. Referring to Figures 10-12, the container 250 is shown in detail. In Figures 10 and 11, the container 250 has been polished with the frame 240 and the harbor barrier film located against the container barrier film. 260. Preferably, the container 250 is formed by a plurality of walls 251 defining the interior cavity 252. The container includes a separate recessed area 253 opposite the opening 255 for containing the second replacement port barrier film 240 '. .

Preferably, a rim 256 is provided around the opening 255 for sealingly bonding the container barrier film 260 to seal the aperture 255 with the decontaminated objects, and the second replacement barrier film 240 'in the interior cavity 252. A container barrier film 260 is sealingly connected to the container 250, preferably on a container rim 256. However, it can be sealingly connected to the container 250 in any desired manner, as long as the interior cavity 252 is sealed for retaining the decontaminated objects 214 and the second replacement port barrier film 240 'in a decontaminated state. The container barrier film 260 has a first decontaminated side 260a facing the cavity 252, and an exposed second side 260b that can be placed adjacent the first port barrier film 240. The container barrier film 260 and the container opening can be limited to the size of the port barrier film 240, as shown in FIG. shown in Figures 10 and 11, or may extend over a container opening that is larger than port 228 as indicated by item number 260 ', shown in Figure 12. A separation and sealing element 276 is located within the insulated space 222, and is mounted to move to a position in use, as shown in Figure 9 (e), adjacent to the first port barrier film 240. Preferably, the separation and sealing member 276 is mounted on a door assembly 278. The separation and sealing member 276 is adapted to separate the first port and container barrier films 240, 260 to define a transfer opening 280 through them having edges 282 in the first port and container barrier films 240, 260, and for simultaneously sealing and decontaminating the edges 282 of the first port and container barrier films 240, 260, a similar way to that of the first modality. The decontaminated objects 214 can then be passed into the insulated space 222 through the transfer opening 280, while maintaining the decontaminated environment, as shown in Figure 9 (a). Referring to Figures 9 (a) - 9 (e), the process for transferring objects 214 in the isolated space according to the third preferred embodiment of the invention will be explained. First, a container 250 is placed adjacent to the port barrier film 240 over the port opening 228, the container barrier film 260 being placed with its second exposed side 260b in surface engagement with the second exposed side 240b of the film of the port barrier, as shown in Figure 9 (e). the separation and sealing element 276 is then moved to a position adjacent to the decontaminated side 240a of the port barrier film 240, and activated to simultaneously create the transfer aperture 280 in the first port and container barrier films 240, 260, and sealing the edges 282 formed around the transfer aperture 280 in the first port and container barrier films 240, 260 together. The decontaminated objects 214 are then passed into the insulated space 222, as shown in Figure 9 (a). The frame 242 'with the second replacement port barrier film 240' is then removed from the compartment 253 in the container 250 using a robotic arm 302 of a robot 300. The robotic arm 302 passes through the transfer opening 280 after that the objects 214 have been emptied from the container 250, as shown in Figure 9 (b). The frame 242 'with the second replacement barrier film 240' is oriented such that its short side is aligned with the transfer aperture 280 so that it can be brought into the insulated space 222. As shown in Figure 9 (c), the robotic arm 302 then rotates to the frame 242 'with the second replacement port barrier film 240' to the proper orientation so that it can be aligned with the port opening 228 and inserted. As the frame 242 'is inserted into the port opening 228, the annular seals 236 sealingly engage the sides of the frame 242'. As shown in Figure 9 (d), the continuous insertion of the frame 242 'with the second replacement port barrier film 240' forces the first frame 240 with the first port barrier film 240, which is now attached to the container barrier film 260, outside the port opening 228. This results in the configuration shown in Figure 9 (e), the port barrier film 240 'now being in position in the port opening 228 so that a next container 250 of objects that will be delivered to the insulated space 222 can be put into position and the process repeated. This provides additional advantages over the first preferred embodiment because a new replacement port barrier film is provided with each container 250 of new objects 214. It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. Therefore, it is understood that this invention is not limited to the particular embodiments described, but that it is intended to cover the modifications within the spirit and scope of the present invention, as defined in the appended claims.

Claims (24)

NOVELTY OF THE INVENTION CLAIMS

1. - A transfer system for transferring objects in a barrier insulator that includes a barrier wall to maintain a decontaminated environment in an isolated space, the transfer system comprising: a port opening located in the barrier wall to provide access to the space isolated; a first port barrier film sealably located on the port opening, the port barrier film having a first decontaminated side that faces the insulated space and a second side that faces out of the insulated space; a container adapted to retain the objects that will be delivered through the port opening and within the insulated space, the container has an interior cavity adapted to receive decontaminated objects and an exposed exterior; a container barrier film coupled in a form to the container so that the decontaminated objects are adapted to be sealed within the cavity in the container and remain decontaminated in the cavity, the container barrier film has a first decontaminated side that gives the cavity, and an exposed second side that can be placed adjacent to the port barrier film; a separating and sealing element located within the insulated space adjacent to the port opening, mounted to be moved from a first position to a second position in use adjacent to the first side of the port barrier film, wherein the separation element and sealing is adapted to separate the first port barrier film and the container barrier film to define a transfer opening having edges in the first port barrier film and in the container barrier film and to seal simultaneously and decontaminating the edges of the first port barrier film and the container barrier film, such that the exposed and potentially contaminated second sides of the first port barrier film and the container barrier film are interlocked and remain isolated from the isolated space, with which the decontaminated objects inside the A container cavity can be passed through the transfer opening and into the insulated space while maintaining the decontaminated environment.

2. The transfer system according to claim 1, further characterized in that the container includes a rim and the separation and sealing element is aligned with the rim, and a protector is located on the rim to prevent the separation element and sealing act on the flange.

3. The transfer system according to claim 2, further characterized in that the protector prevents the barrier films adhere to a portion of the rim.

4. - The transfer system according to claim 1, further characterized in that the separation and sealing element is aligned along an interior edge of the rim, and an external member applies external pressure to the container to support and separate the barrier films .

5. The transfer system according to claim 1, further comprising a reinforcement extending around the port opening in the barrier wall, the reinforcement has a surface surrounding the port opening and a depth, a plurality of separate annular seals being located on the surface, the port barrier film being mounted on a frame having an outer periphery that is complementary to the port opening, whereby the outer periphery of the frame is sealingly coupled by at least for an annular seal and is displaceably slidable through the port opening.

6. The transfer system according to claim 5, further characterized in that a plurality of frames are located within the contained space, each frame has a port barrier film bonded thereto and a thickness, and the depth of the reinforcing surface is greater than the thickness of two frames so that a first frame with an associated container connected by the separated and sealed barrier films can be moved out of the port opening while a second frame is sealably coupled by at least one annular seal in the port opening to maintain the insulation of the isolated space when the first frame is removed.

7. The transfer system according to claim 1, further characterized in that the separation and sealing element is adapted to simultaneously seal and separate the port and container barrier films along edges to form a flap.

8. The compliance transfer system according to claim 1, further characterized in that the port barrier film is provided as a pre-sterilized roll of material and is supplied through the port opening.

9. The transfer system according to claim 8, further characterized in that the pre-sterilized roll of the port barrier film is rotatably supported in a microbial annihilation housing located adjacent to the port opening.

10. The transfer system according to claim 1, further comprising a flap support that can be moved between a first position, wherein the flap holder is adapted to couple a flap formed by a portion separated from the flaps. port and container barrier films and to keep the flap in a closed position, and a second position, in which the holder moves away from the port opening and allows the flap to open.

11. - The transfer system according to claim 1, further characterized in that the separating and sealing element is a heating element.

12. The transfer system according to claim 1, further characterized in that the interior cavity of the container contains a second replacement port barrier film that is adapted to be delivered through the port opening and into the insulated space , and the container barrier film also maintains the second replacement port barrier film within the cavity in a decontaminated state.

13. The transfer system according to claim 12, further comprising a holder located adjacent to the port opening and adapted to position the container against the port opening with the second side of the first port barrier film in surface engagement with the second side of the container barrier film.

14. The transfer system according to claim 12, further comprising a surface that surrounds the port opening in the barrier wall, the surface has a depth, and a plurality of separate annular seals are located on the surface, the first port barrier film being mounted on a first frame having an outer periphery that is complementary to the port opening; the second replacement port barrier film being mounted in a second frame having an outer periphery that is complementary to the port opening, the outer periphery of the first and second frames being adapted to be sealably coupled by at least one ring seal and being displaceable in a sliding manner through the port opening.

15. The transfer system according to claim 14, further characterized in that the second frame is located within the container with the second replacement barrier film.

16. The transfer system according to claim 14, further characterized in that the first and second frames each have a thickness, and the depth of the surface is greater than the combined thicknesses of the first and second frames so that the first frame with an associated container connected by the separated and sealed barrier films can be displaced out of the port opening while the second frame is sealingly coupled by at least one annular seal in the port opening to maintain the isolation of the space isolated when the first frame is removed.

17. The transfer system according to claim 12, further comprising a robotic arm located within the insulated space, the robotic arm being adapted to remove the second barrier film from the replacement port of the container and sealably install the second replacement port barrier film at the port opening before removal of the container with the first port barrier film.

18. The transfer system according to claim 12, further characterized in that the container includes a rim and the container barrier film is sealably connected to the rim, and a protector is located between the container barrier film and the flange to prevent the separation and sealing element acting on the flange.

19. A method for supplying decontaminated objects to a decontaminated environment in an isolated space delimited by a barrier wall, comprising the steps of: (a) providing a port opening in the barrier wall having a first barrier film of port with a first decontaminated side that faces towards the isolated space to close the isolated space and a second exposed side; (b) attaching a container to the port opening, the container has a decontaminated interior cavity with decontaminated objects sealed within the cavity by a container barrier film, the container barrier film has a first decontaminated side and a second side exposed, the second side of the first port barrier film being in surface engagement with the second side of the container barrier film; (c) simultaneously creating a transfer aperture in the first port barrier film and the container barrier film and sealing the edges formed around the transfer aperture in the first port barrier film and in the film container barrier with a separation and sealing element located within the insulated space; Y (d) transferring the decontaminated objects from the interior of the container, through the transfer opening in the first port barrier film and in the container barrier film, and in the insulated space.

20. The method according to claim 19, further comprising the steps of: (e) sealing the port opening with a next port barrier film; (f) remove the sealed port and container barrier films with the container.

21. The method according to claim 20, further comprising the step of: (g) providing a next container; (h) repeat steps (b), (c) and (d) with the next barrier film of port and the next container.

22. The method according to claim 19, further comprising: providing a second sealed replacement port barrier film within the container cavity and transferring the second replacement port barrier film from the container, through of the transfer opening in the first port barrier film and the container barrier film, and within the insulated space.

23. A container for use in a transfer system for transferring objects in a barrier insulator comprising a barrier wall for maintaining a decontaminated environment in an insulated space, the barrier insulator having a port opening with a first film of port barrier sealing the port opening, the container comprises: a plurality of walls defining an interior cavity with an opening, a second replacement port barrier film located in the cavity, the interior cavity being further adapted to hold objects which will be supplied with the second replacement port barrier film through the port opening and in the insulated space, and a container barrier film connected to the container to seal the cavity.

24. The container according to claim 23, further comprising an elongated recess located in the interior cavity opposite the container opening, the recess being adapted to receive the second replacement port barrier film.