Filter system and method for drug-filled isolator

Abstract

A system and method for mounting an exhaust filter to a drug isolator includes a set of parallel cams coupled by rigid rods to urge a filter carrier containing the filter along the set of parallel spring-loaded linear guide rods. The system engages the exhaust filter with the exhaust flange of the controlled environment enclosure at a laterally uniform pressure. In order to ensure that the exhaust filter is not sealable when incorrectly loaded in the filter bracket, the interlock bar impedes movement of the filter bracket along the linear guide bar if the exhaust filter is not completely inserted into the filter bracket. The system is used for drug filling devices in which sterile internal environmental conditions must be maintained under positive differential pressure.

Description

[0001] Cross-reference to related applications

[0002] This application is a PCT international patent application claiming priority under PCT and 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63 / 445,068 filed on February 13, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the medical field as exemplified by IPCA Class 61, and more particularly to apparatus and associated methods for sterilizing and disposing of pharmaceutical materials and containers of pharmaceuticals, including placing pharmaceuticals in a form for administration to medical or veterinary patients. In one aspect, the present disclosure relates to maintaining appropriate sterile conditions in conjunction with efficient processing using such apparatus and systems. Background Art

[0004] The SARS-CoV-2 pandemic of the third decade of the 21st century has provided the backdrop for tightening environmental controls on technical processes in the pharmaceutical industry. Equipment, machinery, and all aspects of processes in this industry are now subject to increased scrutiny. Even for the layperson, it's becoming clear that the environment inside a medical isolator box is as important to the environment outside the isolator as it is to the materials inside.

[0005] In the pharmaceutical field, the filling of sterile pharmaceutical containers with drug substances is carried out under carefully controlled sterilization or aseptic conditions. Container filling equipment is typically installed and operated in a medical clean laboratory environment with a controlled atmosphere under extremely strictly specified conditions. The U.S. Food and Drug Administration (FDA) and other international organizations including the International Organization for Standardization (ISO) also have well-established and stringent regulations for medical-grade isolators containing filling equipment.

[0006] Although clean laboratories housing filling equipment used in the pharmaceutical industry operate under strictly defined conditions, every effort must be made to ensure that there is no cross-contamination between the interior of the filling equipment and the clean laboratory environment in which the equipment is housed and operated. To this end, the air entering the filling equipment from the clean laboratory environment is filtered. Similarly, the air leaving the equipment and entering the clean laboratory is also filtered with the aid of one or more exhaust filters.

[0007] In the prior art, the exhaust filter of the filling device is typically manually installed to the exhaust port on the controlled environment enclosure of the device. In the pharmaceutical industry, the controlled environment enclosure is commonly referred to as an "isolator". This installation most typically includes manually assembling the filter to the exhaust port of the isolator and then tightening a plurality of peripherally arranged bolts or other tightening devices. If the filter is not correctly placed, the exhaust filter or the gasket that seals the exhaust filter to the isolator may be deformed, and the assembled and deformed filter may leak. This will typically require shutting down the entire operation, reinstalling and resealing the filter and reestablishing the sterilization conditions in the isolator. This avoidable downtime has a significant impact on the industry that must produce billions of doses of vaccines that are filled into the barrels used in injection needles (taking SARS-CoV-2 virus as an example only).

[0008] Any steps that can be taken to avoid or shorten interruptions to the medication filling process will be welcomed by the pharmaceutical industry.The present disclosure addresses the problem of ensuring that an exhaust filter is reliably and correctly installed in a medical isolator. Summary of the Invention

[0009] In one aspect, a filter mount system for mounting a filter in overlying alignment with a port of a controlled environment enclosure is provided, the filter having a planar sealing surface that circumferentially defines a porous filter medium, wherein the enclosure includes a flange having a planar sealing surface that surrounds the port, the system comprising: a mount frame that mounts around the planar sealing surface of the flange; a manually operated single-acting actuation subsystem; and a filter bracket for receiving the filter, wherein the planar sealing surface of the filter is constrained by the filter bracket to be parallel to the planar sealing surface of the flange. The filter bracket is constrained by the single-acting actuation subsystem to translate perpendicularly to the planar sealing surface of the flange within the mount frame to achieve sealing engagement of the planar sealing surface of the filter with the planar sealing surface of the flange, thereby positioning the filter in overlying alignment with the port.

[0010] A manually operated, single-acting actuation subsystem may include: a plurality of cams configured to rotate in a plane parallel to the planar sealing surface of the flange; and a handle rigidly connecting the plurality of cams to one another. The cams are configured to rotate about a common axis in a plane parallel to the planar sealing surface of the flange. The filter bracket may include one or more push plates having a planar surface parallel to the planar sealing surface of the flange. The filter bracket is translatably mounted within a mounting frame on a plurality of linear guides extending perpendicular to the planar sealing surface of the flange and slidably extending through the bracket. The plurality of cams are configured to mechanically act on the one or more push plates to urge the filter bracket along the plurality of linear guides in a path perpendicular to the planar sealing surface of the flange. The linear guides include concentrically mounted compression springs configured to be compressed when the filter bracket translates on the linear guides toward the planar sealing surface of the flange under the action of the cams on the push plates. A manually operated single-acting actuation subsystem effects sealing engagement of the filter's planar sealing surface with the flange's planar sealing surface via one manual partial rotation of the handle about the cam's common axis.

[0011] The mounting frame may include an interlocking mechanism arranged to prevent movement of the filter holder perpendicular to the planar sealing surface of the flange if the filter is not fully inserted into the filter holder. The interlocking system may include an interlocking rod having a peg at each longitudinal end and two slots extending substantially parallel to the planar sealing surface of the flange in the upper and lower end pieces of the mounting frame. Each peg is attached to the mounting frame by an extension spring arranged to retain the interlocking rod in a position that blocks movement of the filter holder perpendicular to the planar sealing surface of the flange. When the filter is inserted into the filter holder, the two pegs slide in the two slots, and the filter pushes the interlocking rod out of the position in which the interlocking rod blocks movement of the filter holder perpendicular to the planar sealing surface of the flange, thereby enabling sealing engagement around the port by the planar sealing surface of the filter.

[0012] The filter mount system may include at least two cooperating retaining devices disposed on the mount frame and the manually operable single-acting actuation subsystem. The retaining devices are arranged to retain the manually operable single-acting actuation subsystem in a state in which a planar sealing surface of the filter is sealingly engaged with a planar sealing surface of the flange when the retaining devices engage each other. The controlled environment enclosure may be a pharmaceutical isolator, and the port may be an air exhaust port in fluid communication with a fluid distribution interior of the controlled environment enclosure.

[0013] In another aspect, a method for sealing a filter in stacking alignment with a port of a controlled environment enclosure is provided, the filter having a planar sealing surface that circumferentially defines a porous filter medium, the method comprising providing a mechanical filter mounting system that attaches the planar sealing surface of a flange surrounding the port to the enclosure. The filter mounting system comprises a manually operated single-acting actuation subsystem and a filter carrier for receiving the filter, wherein the planar sealing surface of the filter is constrained by the filter carrier to be parallel to the planar sealing surface of the flange; and the filter carrier is constrained to translate perpendicular to the planar sealing surface of the flange under the action of the single-acting actuation subsystem. The filter is inserted into the filter carrier, wherein the planar sealing surface of the filter is parallel to the planar sealing surface of the flange, so that the filter is positioned in stacking alignment with the port, and the planar sealing surface of the filter is sealingly engaged with the planar sealing surface of the flange by a single action manually applied to the single-acting actuation subsystem.

[0014] A manually operated single-acting actuation subsystem may include: a plurality of cams arranged to rotate in parallel planes about a common axis in a plane parallel to the planar sealing surface of the flange; and a handle rigidly connecting the plurality of cams to each other so that a single action of sealing may include a single manual partial rotation of the handle about the common axis of the cams.

[0015] The filter mount may include an interlock mechanism that resists translation of the filter bracket perpendicular to the planar sealing surface of the flange, and inserting the filter may include fully inserting the filter into the filter bracket, thereby forcing the interlock mechanism aside to allow the bracket to move.

[0016] The filter mounting system may include at least two cooperating retaining devices respectively arranged on the frame of the mounting and the manually operated single-acting actuating subsystem, and the method may further include engaging the retaining devices with each other to retain the manually operated single-acting actuating subsystem in a state in which the planar sealing surface of the filter is sealingly engaged with the planar sealing surface of the flange. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above-mentioned features and objects of the present invention, as well as other features and objects and the manner of achieving them, will become more apparent, and the invention itself will be better understood, by referring to the following description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which:

[0018] Figure 1 is a schematic diagram of one embodiment of a drug filling device including a controlled environment enclosure.

[0019] Figure 2 Display suitable for Figure 1 Schematic diagram of an exhaust filter used with the device.

[0020] Figure 3 is used to Figure 2 The exhaust filter is installed to Figure 1 View of the exhaust filter mounting for the device.

[0021] Figure 4 show Figure 3 A view of the exhaust filter mounting assembly from the opposite direction, wherein Figure 2 The exhaust filter is installed in the filter bracket of the exhaust filter mounting.

[0022] Figure 5A show Figure 3 An exhaust filter mount is provided wherein the filter bracket is in a retracted position and the filter mount is in an open condition.

[0023] Figure 5B Displays the closed state Figure 3 The exhaust filter mount of the embodiment of the present invention is characterized in that the filter bracket is in the closed position to Figure 2 The exhaust filter is sealed to Figure 1 Exhaust flange of a controlled environment enclosure.

[0024] Figure 6 is a flow chart of a method for sealing an exhaust filter to an exhaust flange of a controlled environment enclosure.

[0025] Throughout the several views, corresponding reference characters indicate corresponding parts. Although the drawings represent embodiments of the present invention, they are not necessarily drawn to scale and certain features may be exaggerated to better illustrate and explain the present invention. The illustrations set forth herein illustrate embodiments of the present invention in one form and are not to be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION

[0026] The embodiments disclosed below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can utilize their teachings.

[0027] Figure 1A drug filling device 100 is shown that includes a controlled environment enclosure 110. The controlled environment enclosure 110 can be a sterilely sealable medical or pharmaceutical isolator that can be sterilized internally and can maintain sterile conditions in its interior. The enclosure 110 can be equipped with an air pressure control subsystem (not shown) for controlling the air pressure inside the enclosure 110. The air pressure control subsystem can include suitable pumps and valves. Suitable pressure control subsystems are well known to practitioners in the art. The controlled environment enclosure 110 can accommodate various complex mechanical and servomechanical devices for manipulating drug containers and their closures. The enclosure 110 can also accommodate various mechanical and servomechanical devices for manipulating at least one drug filling needle for dispensing the drug. The drug can typically, but not exclusively, be a fluid. An electronic control system for controlling or programming activities inside the enclosure 110 can also be attached to the exterior of the enclosure. To this end, Figure 1 A general controller 120 is shown connected to the enclosure 110 and various devices inside the enclosure 110. Figure 3 、 Figure 4 as well as Figure 5A and Figure 5B The exhaust filter mount 300, which is described in more detail, seals the exhaust filter 200 to a flange surrounding a port 150 in the enclosure 110 in a recessed portion 130 on the exterior of the enclosure 110. The exhaust filter 200 is configured to filter air exhausted from the enclosure 110 via the port 150. The recessed portion 130 can be closed by a door (not shown for clarity). When closed, the door can be closed airtightly onto the frame of the enclosure 110 so that air exhausted through any filter mounted in the exhaust filter mount 300 is exhausted through the exhaust port 140 shown in the base of the enclosure 110. Air exhausted through the exhaust port 140 can be recirculated through the enclosure 110 via a suitable input filter, or can be exhausted into a clean laboratory environment. The apparatus 100 may include a plurality of exhaust filter mounts 300 having filters 200.

[0028] For the purpose of this specification, the terms "aseptic" and "sterilization" and their derivatives are understood as follows. Establishing aseptic conditions in the inside of the enclosure should be understood to mean establishing this condition in the entire internal atmosphere of the enclosure and on substantially all exposed inner surfaces of the enclosure. This should include the surfaces of all articles, containers, subsystems, etc. that are exposed to the internal atmosphere of the enclosure. In the case where there may be extremely narrow cracks or tiny cracks in the inside of the enclosure, sterilizing gases or steam may not fully penetrate into such narrow areas. Therefore, the degree of sterilization under actual conditions may not be complete. This is generally recognized in both the industry and the standards set for the industry. The action of establishing aseptic conditions in the inside of the enclosure and "sterilizing the inside of the enclosure" should have the same meaning in this specification.

[0029] In the inside of the capsule that its surface is not suitably sterilized, the article is introduced into and destroys the existing aseptic condition in the capsule.On the contrary, sterile or sterilized article is introduced into the inside (does not have aseptic condition in this inside) of capsule and can not cause this interior sterile.In fact, what it does is just destroy the aseptic condition on the surface of the article introduced so.Similarly, even if filtered air is introduced into the unsterilized capsule when all biological entities are filtered out, capsule can not be sterilized in any way or cause the aseptic degree of capsule to reach in the pharmaceutical industry.Reason is that the inner surface of capsule is not sterilized by the introduction of such air.What is realized is just to utilize the active biological substance that resides on the inner surface of unsterilized capsule to pollute filtered air.

[0030] For the sake of clarity and completeness, it should also be noted that in this area, the term "sterile" is sometimes also used in association with the introduction of a drug fluid along a sterile tube into a body within a controlled enclosure. In such cases, the term in this area refers to the condition of the tube interior or the fact that the drug fluid can be filtered to an appropriate degree. This in no way sterilizes or renders the interior of the enclosure in question sterile. The sterile conditions in such cases are limited to the interior of the tube carrying the drug flow. Such a flow is usually filtered to a high degree, but such filtration only affects the interior of a particular tube and does not sterilize the interior of the enclosure in any way.

[0031] In some prior art systems, containers introduced into a capsule for the purpose of filling with a drug are guided through a sterilization subsystem. This kills biological matter on the container. When such a sterilized container is introduced into a capsule when the capsule itself is not sterile, the container loses its sterility because the biological matter contained in the capsule will be deposited on the previously sterile container.

[0032] It should also be noted that pharmaceutical or semiconductor clean rooms of any quality level (including "Class 100," "Class 10," or "Class 1") do not constitute sterile enclosures, even when employing laminar flow hoods or the like, or HEPA (High Efficiency Particulate Air) filters or ULPA (Ultra Low Particulate Air) filters of any quality, because they do not have a guaranteed means of rendering the surfaces of the room sterile or aseptic. Standards exist for clean rooms, both according to the U.S. Food and Drug Administration and the ISO (International Organization for Standardization). These specify in great detail the permitted particle content of a cubic volume of air in such clean room facilities, according to different standards. None of these standards addresses the problem of biological matter present on surfaces in the room. This serves to illustrate that an enclosure cannot be rendered sterile by merely managing the atmosphere or air flow of the enclosure. Conversely, an enclosure cannot be rendered sterile by merely sterilizing the surfaces of the interior of the enclosure.

[0033] The text "Guidelines for Disinfection and Sterilization in Health Care Facilities 2008" by Rutala et al. from the Centers for Disease Control lists a summary of the mechanisms and methods for sterilization and is hereby incorporated by reference in its entirety as if fully disclosed in this description. Our focus in this specification is specifically on those mechanisms for sterilizing the interior of the capsule (i.e., sterilizing both the inner surface and the atmosphere within the capsule). In view of the requirements, steam-based methods are most suitable for this task. These include, but are not limited to, the disposal of heated water vapor, hydrogen peroxide vapor, ozone, nitrogen dioxide, ethylene oxide, glutaraldehyde vapor or other suitable sterilizing gases and vapors. In a suitable method suitable for the present invention, sterilization is carried out by means of hydrogen peroxide vapor, and then ozone is used to flush the hydrogen peroxide vapor before the capsule is used for filling of the drug container.

[0034] As used herein, the term "decontamination" refers to a process for removing or inactivating contaminants (including but not limited to viruses, bacteria, spores, prions, molds, yeasts, proteins, pyrogens, and endotoxins) to acceptable levels. As used herein, "decontamination" includes both sterilization (i.e., destroying all microorganisms, including bacterial spores, to a probability of typically less than 1:106 of leaving an organism alive) and disinfection (i.e., destroying and removing specific types of microorganisms).

[0035] In order to achieve a suitable sterilization level, the enclosure 110 can be hermetically sealed. In one embodiment, the hermetic seal provided by the enclosure 110 is sufficient to meet the predetermined requirements of the ISO standard ISO10648-2 entitled "Containment enclosures Part 2 - Classification according to leak tightness and associated inspection methods." Specifically, the seal is preferably sufficient to meet level 3, or more preferably level 2, or even more preferably level 1. In another embodiment, the hermetic seal provided by the enclosure 100 is sufficient to meet the predetermined requirements of the PDA Pharmaceutical Science and Technology Technical Report magazine No. 34 entitled "Design and Verification of Isolator Systems for the Manufacture and Testing of Health Care Products" (September / October 2001). The disclosures of both of these documents are incorporated herein by reference in their entirety, as if fully disclosed herein.

[0036] Figure 2A schematic diagram of an exhaust filter 200 suitable for use with the device 100 is shown. The filter includes a filter element 210, which may be made of, for example, but not limited to, porous PTFE or fiberglass. The filter 200 may further include a filter frame 220 to accommodate the porous filter element or media 210. A compressible gasket 230 is ideally positioned on the planar air inlet surface 240 of the filter element 210. The planar air inlet surface 240 is indicated by a solid diagonal line. The gasket 230 delimits the porous filter element 210 of the filter 200 along its perimeter and forms a planar sealing surface for the filter 200. The opposite external air outlet surface 260 of the filter 200 is shown by a dashed diagonal line. Two brackets 250 are attached to the filter frame 220 at opposite ends thereof. One bracket 250, located at the distal end of the exhaust filter 200, is obscured by the filter 200 and is shown by a dashed line. The bracket 250 is used to guide the exhaust filter 200 when the exhaust filter 200 is manually inserted into the filter bracket 310 (see Figure 3 and Figure 5A ).

[0037] When the exhaust filter 200 is mounted to the enclosure 110 by means of the exhaust filter mount 300, the exhaust filter 200 is positioned in overlying alignment with the port 150, and the gasket 230, which serves as the planar sealing surface of the filter 200, sealingly engages the planar sealing surface 170 of the flange 160 (see FIG. Figure 4 ) so that the air inlet surface 240 is exposed to the interior of the enclosure 110 and thereby to heated water vapor, hydrogen peroxide vapor, ozone, nitrogen dioxide, ethylene oxide, glutaraldehyde vapor, or other suitable sterilizing gases and vapors used to sterilize the interior of the enclosure 110, as described above. The filter 200 must therefore be compatible with these gases and vapors and the processes used to employ them. Figure 2 In the embodiment shown in FIG, exhaust filter 200 is shown as having a rectangular shape. In other embodiments, the exhaust filter can have a variety of other suitable shapes, including but not limited to a circular shape.

[0038] Figure 3 The exhaust filter mount 300 is shown in greater detail without the exhaust filter 200 present. The entire exhaust filter mount 300 may be permanently attached to the exterior of the enclosure 110 within the recessed portion 130 on the exterior of the enclosure 110. Figure 1 In one embodiment shown in FIG, the exhaust filter mount 300 is arranged so that its longest dimension is arranged vertically. In other embodiments, the exhaust filter mount 300 can be arranged in other orientations that allow the gasket 230 to sealingly engage the exhaust flange 160 of the outer surface of the enclosure 110. For a detailed view of the exhaust flange 160, see the exhaust flange 160 described below. Figure 4 、 Figure 5A as well as Figure 5B .

[0039] When a door (not shown) of the recessed portion 130 leading to the outside of the enclosure 110 is closed, exhaust air exhausted from the enclosure 110 via the exhaust filter 200 is drawn out via the discharge port 140. A filtering action of the exhaust filter 200 occurs during this process.

[0040] The exhaust filter mount 300 includes a movable filter bracket 310. The filter bracket 310 includes two push plates 312 at either of its longitudinal ends, both of which are arranged to move along a plurality of linear guides 322 within a mount frame 320 of the exhaust filter mount 300 while compressing a corresponding plurality of springs 324 concentrically disposed on the corresponding linear guides 322. Figure 3 , four linear guides 322 are shown, each having one spring 324 arranged concentrically therearound. For clarity, only one linear guide 322 and its corresponding spring 324 are labeled at the bottom of the mount frame 320. Figure 5A and Figure 5B The linear guide 322 and spring 324 are seen in more detail in FIG.

[0041] The filter bracket 310 is urged along the path of motion of the filter bracket 310 within the mount frame 320 along the linear guide 322 by a cam subsystem 330 comprising two cams 332 rigidly coupled together by a rigid handle 334. The cam subsystem 330 is described herein as a "manually operated single-acting actuation subsystem". One of the cams 332, connected to the handle 334, is in the Figure 3 334. The cam axes 336 are parallel to the planar sealing surface of the exhaust filter 200 when the exhaust filter 200 is installed in the exhaust filter mount 300. Figure 2 In the case of a filter, parallel to the gasket 230). The cam axis 336 is thus also parallel to the Figure 5A and Figure 5B The exhaust flange 160 is shown in FIG. Figure 3 、 Figure 4 、 Figure 5A as well as Figure 5B Different views are shown of a cam 332 acting on a push plate 312. The push plate 312 is provided with a suitable hole 314 arranged for sliding along a linear guide 322 and is arranged to compress a spring 324 under the action of the cam 332.

[0042] Figure 4 Exhaust filter mounting 300 is shown in FIG. Figure 3 A view in the opposite direction of the exhaust filter 200 is shown, in which the exhaust filter 200 is mounted in the filter bracket 310 of the exhaust filter mount 300. Figure 4 , the gasket 230 of the exhaust filter 200 is facing away from the viewer. This view of the exhaust filter mount 300 shows two cams 332. However, the linear guide 322 and the spring 324 are obscured in this view. Figure 4 Also shown is the port 150 of the enclosure 110 surrounded by a flange 160 having a planar sealing surface 170 to which the filter 200 is configured to seal.

[0043] Figure 5A A top view of the exhaust filter mount 300 is shown with the filter bracket 310 retracted around the port 150 away from the exhaust flange 160. The spring 324 surrounding the linear guide 322 is relaxed. The exhaust filter 200 is shown not fully inserted into the filter bracket 310. Figure 5B The same view of the exhaust filter mount 300 is shown with the filter bracket 310 in a closed position where the spring 324 is compressed around the linear guide 322. The exhaust filter 200 is in a clamped condition, under pressure to seal to the exhaust flange 160 of the enclosure 110. The port 150 of the enclosure 110 is in Figure 5A and Figure 5B The two are shown with dashed lines.

[0044] The handle 334 is rotatable about the cam axis 336 ( Figure 5A and Figure 5B The handle 334 may be rotated in the opposite direction (counterclockwise) to retract the filter holder 310 to thereby move the exhaust filter 200 away from the exhaust flange 160 of the enclosure 110. This would typically be done to replace the exhaust filter 200 in the filter holder 310. To seal the exhaust filter 200 to the enclosure 110, the handle 334 may be rotated in the opposite direction (counterclockwise). Figure 5B 160 ). This rotation will push the filter bracket 310 along the plurality of linear guides 322 while compressing the spring 324. This action can continue until the gasket 230 is sealed with the exhaust flange 160. The spring 324 can be arranged so that when the gasket 230 has been sealed to the exterior of the enclosure 110, the spring 324 is sufficiently compressed to generate a force sufficient to force the gasket 230 away from the exhaust flange 160. For this reason, as shown in FIG. Figure 3As shown in , cooperating retaining means 326 and 338 may be provided on the mount frame 320 and the cam subsystem 330, respectively, to hold the cam subsystem 330 in a closed position and thereby seal the exhaust filter 200 to the exterior of the enclosure 110 when the apparatus 100 is in use. Figure 3 16. In the embodiment of the present invention, the cooperating retaining devices 326 and 338 form an elbow latch therebetween. In other embodiments, alternative retaining devices may be employed. The retaining devices of elements 326 and 338 may be released to rotate handle 334 to an open position to thereby move filter bracket 310 and exhaust filter 200 away from exhaust flange 160 to facilitate removal of exhaust filter 200.

[0045] The arrangement of the exhaust filter mount 300 and its specific mode of operation allow the exhaust filter 200, mounted in the filter bracket 310, to sealingly engage the exhaust flange 160 on the exterior of the enclosure 110 with uniform pressure across the entire surface of the gasket 230, which acts as a planar sealing surface for the filter 200. The apparatus, mechanism, and method effectively counteract leakage problems associated with prior art manual installation of exhaust filters.

[0046] The drug filling device 100 is configured to not open the servo-mechanical filling device in the enclosure 110 unless a positive atmospheric pressure is detected in the enclosure compared to the external environment surrounding the device 100. To this end, the exhaust filter mount 300 may be equipped with an interlock mechanism. Figure 3 、 Figure 4 、 Figure 5A as well as Figure 5B In the embodiment of the present invention, the exhaust filter mount 300 has an interlocking rod 340 that engages with the mount frame 320 and is arranged to ensure that the exhaust filter 200 cannot sealingly engage the exhaust flange 160 of the enclosure 110 to establish a positive differential pressure unless the interlocking rod 340 is properly positioned. The interlocking rod 340, in turn, cannot be placed in the required position unless the exhaust filter 200 is fully and correctly inserted into the filter bracket 310. Unless the exhaust filter 200 is fully inserted into the filter bracket 310, the interlocking rod 340 obstructs the path of the filter bracket 310 along the plurality of linear guides 322. With the path of the filter bracket 310 thus obstructed, the exhaust filter 200 cannot be sealed to the exhaust flange 160 of the enclosure 110, positive pressure cannot be established in the enclosure 110, and the entire device 100 cannot be electrically activated.

[0047] To this end, the interlocking rod 340 comprises two pins 342, one pin 342 at either longitudinal end of the interlocking rod 340, each pin 342 extending in the longitudinal direction from its respective end of the interlocking rod 340, each pin 342 thereby extending along the same longitudinal axis. The pins 342 slide in two corresponding slots 344, one slot 344 being arranged at either longitudinal end of the mounting frame 320. The slots 344 are precisely mapped onto each other along the longitudinal axis of the mounting frame 320. Each of the pins 342 is provided with an extension spring 346, which is attached to a corresponding fixing point on the corresponding longitudinal end of the mounting frame 320. The spring 346 is therefore arranged to ensure that the interlocking rod 340 obstructs the path of the filter bracket 310 along the plurality of linear guides 322 unless the exhaust filter 200 is fully inserted into the filter bracket 310. In Figure 5A In the embodiment, the interlocking rod 340 (obscured by the mounting frame 320 in this view, but Figure 3 344) has not yet been engaged, and the corresponding pin 342 is therefore still in its extreme rightmost position in the slot 344. The spring 346 is shown in an equally relaxed state. When the exhaust filter 200 is fully inserted into the filter holder 310, it stops against a stop 348 on the filter holder 310. Before reaching the stop 348, the exhaust filter 200 is pushed against the interlocking rod 340 and thereby Figure 3 The interlocking rod 340 is pushed in the lateral direction indicated by the arrow 349 in FIG. The narrow slot 344 is arranged to have the following length: to allow the exhaust filter 200 to push the interlocking rod 340 completely out of the way of the filter bracket 310, thereby allowing the filter bracket 310 to be opened. Figure 3 319 in order to seal the exhaust filter 200 to the planar sealing surface 170 of the exhaust flange 160 of the enclosure 110 .

[0048] The above description provides a filter mount system 300 for mounting a filter 200 in overlying alignment with a port 150 of a controlled environment enclosure 110, the filter 200 having a planar sealing surface in the form of a gasket 230 that circumferentially defines a porous filter medium 210, wherein the enclosure 110 includes a flange 160 having a planar sealing surface 170 surrounding the port 150, the filter mount system 300 comprising: a mount frame 320 that mounts around the planar sealing surface 170 of the flange 160; a manually operated single-acting actuation subsystem 330; and a filter bracket 320. 10, which is used to receive the filter 200, the planar sealing surface of the filter 200 in the form of the gasket 230 being constrained by the filter bracket 310 to be parallel to the planar sealing surface 170 of the flange 160, wherein the filter bracket 310 is constrained to translate perpendicularly to the planar sealing surface 170 of the flange 160 within the mounting member frame 320 under the action of the single-acting actuation subsystem 330 to achieve sealing engagement of the planar sealing surface (gasket 230) of the filter 200 with the planar sealing surface 170 of the flange 160, so that the filter 200 is positioned in overlapping alignment with the port 150.

[0049] The manually operated single-acting actuation subsystem 330 may include a plurality of cams 332 arranged to rotate in a plane parallel to the planar sealing surface 170 of the flange 160, and a handle 334 rigidly connecting the plurality of cams 332 to one another, wherein the cams 332 are arranged to rotate about a common axis in a plane parallel to the planar sealing surface 170 of the flange 160. The filter bracket 310 may include one or more push plates 312 having a planar surface parallel to the planar sealing surface 170 of the flange 160. The filter bracket 310 is translatably mounted within the mounting frame 320 on a plurality of linear guides 322 that extend perpendicular to the planar sealing surface 170 of the flange 160 and slidably extend through the filter bracket 310, and a plurality of cams 332 are configured to mechanically act on one or more push plates 312 to urge the filter bracket 310 along the plurality of linear guides 322 in a path perpendicular to the planar sealing surface 170 of the flange 160. The linear guides 322 have concentrically mounted compression springs 324 that are configured to be compressed when the filter bracket 310 translates on the linear guides 322 toward the planar sealing surface 170 of the flange 160 under the action of the cams 332 on the push plates 312. The manually operated single-acting actuation subsystem 330 effects sealing engagement of the planar sealing surface of the filter 200 with the planar sealing surface 170 of the flange 160 via one manual partial rotation of the handle 334 about the common axis 336 of the cam 332 .

[0050] The mount frame 320 may include an interlocking mechanism ( Figure 3as well as Figure 5A and Figure 5B 160 ) and an interlocking mechanism (e.g., elements 340, 342, 344, and 346) arranged to prevent movement of the filter holder 310 perpendicular to the planar sealing surface 170 of the flange 160 if the filter 200 is not fully inserted into the filter holder 310. The interlocking system may include an interlocking rod 340 having a pin 342 at each longitudinal end and slots 344 extending substantially parallel to the planar sealing surface 170 of the flange 160 in the upper and lower end pieces of the mount frame 320, wherein each pin 342 is attached to the mount frame 320 by an extension spring 346 arranged to retain the interlocking rod 340 in a position that blocks movement of the filter holder 310 perpendicular to the planar sealing surface 170 of the flange 160. As the filter 200 is inserted into the filter holder 310, the pin 342 slides in each of the slots 344 and the filter 200 pushes the interlocking rod 340 out of a position where the interlocking rod 340 blocks movement of the filter holder 310 perpendicular to the planar sealing surface 170 of the flange 160 to enable sealing engagement around the port 150 by the planar sealing surface (gasket 230) of the filter 200.

[0051] The filter mount system 300 may include at least two cooperating retaining devices 326 and 338 disposed on the mount frame 320 and the manually-operated single-acting actuation subsystem 330, respectively, the retaining devices 326 and 338 being arranged to retain the manually-operated single-acting actuation subsystem 330 in a state in which the planar sealing surface of the filter 200 (being the gasket 230) is sealingly engaged with the planar sealing surface 170 of the flange 160 when the retaining devices 326 and 338 are engaged with each other. The controlled environment enclosure 110 may be a pharmaceutical isolator, and the port 150 may be an air exhaust port in fluid communication with the fluid dispensing interior of the controlled environment enclosure.

[0052] In one aspect, a method

[500] is provided for sealing a filter 200 in overlying alignment with a port 150 of a controlled environment enclosure 110, the filter having a planar sealing surface (gasket 230) circumferentially bounding a porous filter medium 210, the method comprising: providing

[510] a mechanical filter mount system 300 attached to the enclosure 110 about a planar sealing surface 170 of a flange 160 surrounding the port 150, wherein the filter mount system 300 may include a manually operated single-acting actuation subsystem 330 and a filter bracket 310 for receiving the filter 200, wherein the planar sealing surface (such as the gasket 230) of the filter 200 is actuated by the filter bracket 310. 0 is constrained to be parallel to the planar sealing surface 170 of the flange 160, and the filter bracket 310 can be constrained to translate perpendicular to the planar sealing surface 170 of the flange 160 under the action of the single-acting actuation subsystem 330;

[520] inserting the filter 200 into the filter bracket 310, wherein the planar sealing surface (gasket 230) of the filter 200 is parallel to the planar sealing surface 170 of the flange 160 so that the filter is positioned in overlapping alignment with the port; and sealingly engaging

[530] the planar sealing surface (gasket 230) of the filter 200 to the planar sealing surface 170 of the flange 160 by a single action manually applied to the single-acting actuation subsystem 330.

[0053] The manually operated single-acting actuation subsystem 330 may include: a plurality of cams 332 configured to rotate in a plane parallel to the planar sealing surface 170 of the flange 160 about a common axis 336; and a handle 334 rigidly connecting the plurality of cams 332 to each other so that a single action of sealing

[520] may include a single manual partial rotation of the handle 334 about the common axis 336 of the cams 332.

[0054] The filter mount system 300 may include an interlocking mechanism that hinders translation of the filter bracket perpendicular to the planar sealing surface 170 of the flange 160, and inserting

[520] the filter 200 may include fully inserting the filter 200 into the filter bracket 310, thereby forcing the interlocking mechanism aside to allow the filter bracket 310 to move.

[0055] The filter mounting system 300 may include at least two cooperating retaining devices 338 and 326 respectively disposed on the frame 320 of the mounting 300 and the manually operated single-acting actuating subsystem 330, and the method

[500] may further include engaging the retaining devices 338 and 326 with each other to retain the manually operated single-acting actuating subsystem 330 in a state in which the planar sealing surface (gasket 230) of the filter 200 is sealingly engaged with the planar sealing surface 170 of the flange 160.

[0056] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The accompanying drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown and described. However, the inventors also contemplate examples in which only those elements shown and described are provided.

[0057] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety, as if individually incorporated by reference. In the event of any inconsistency between the usages of this document and those so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0058] In this document, as is common in patent literature, the terms "a" or "an" are used to include one or more than one, independent of any other instance or usage of "at least one" or "one or more." In this document, unless otherwise indicated, the term "or" is used to refer to a non-exclusive or, such that "A or B" includes "A without B," "B without A," and "A and B." In the appended claims, the terms "including" and "in which" are used as the plain language equivalents of the corresponding terms "comprising" and "wherein." Moreover, in the claims that follow, the terms "including" and "comprising" are open-ended, that is, systems, devices, articles, or processes that include elements in addition to those listed after such terms in a claim are still considered to fall within the scope of the claim. Furthermore, in the claims that follow, the terms "first," "second," and "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

[0059] The above description is intended to be illustrative, not restrictive. For example, the examples described above (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, such as by those of ordinary skill in the art, when reviewing the above description. An abstract is provided to comply with 37 CFR § 1.72 (b) to allow the reader to quickly determine the nature of the technical disclosure. The abstract is submitted with the understanding that the abstract will not be used to interpret or limit the scope or meaning of the claims. Moreover, in the above detailed description, various features may be grouped together to simplify the disclosure. This should not be interpreted as intending that the disclosed features that are not claimed for protection are essential to any claim. On the contrary, the subject matter of the invention may lie in less than all the features of a particular disclosed embodiment. Therefore, the following claims are hereby incorporated into the detailed description, with each claim existing independently as a separate embodiment. The scope of the present invention should be determined with reference to the appended claims together with the full scope of equivalents to which such claims are entitled.

[0060] Although the present invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of the present disclosure. Therefore, this application is intended to cover any variations, uses, or adjustments of the present invention using the general principles of the present invention. Furthermore, this application is intended to cover such deviations from the present disclosure as are known or customary in the art to which the present invention pertains.

Claims

1. A filter mount system for mounting a filter in overlying alignment with a port of a controlled environment enclosure, the filter having a planar sealing surface peripherally defining a porous filter medium, wherein: The enclosure includes a flange having a planar sealing surface surrounding the port, the mounting system comprising: a mounting frame mountable about the planar sealing surface of the flange; a manually operated single-acting actuation subsystem; and a filter holder for receiving the filter, wherein the planar sealing surface of the filter is constrained by the filter holder to be parallel to the planar sealing surface of the flange, wherein the filter bracket is constrained by the single-acting actuation subsystem to translate perpendicularly to the planar sealing surface of the flange within the mounting frame to achieve sealing engagement between the planar sealing surface of the filter and the planar sealing surface of the flange, so that the filter is positioned to be aligned and overlapped with the port.

2. The filter mount system of claim 1, wherein: The single-acting actuation subsystem comprises: a plurality of cams arranged to rotate in parallel planes perpendicular to the planar sealing surface of the flange; and a handle rigidly connecting the plurality of cams to each other, Wherein the cams are arranged to rotate about a common axis in a plane parallel to the planar sealing surface of the flange.

3. The filter mount system of claim 2, wherein: The filter bracket includes one or more push plates having a planar surface parallel to the planar sealing surface of the flange; the filter bracket being translatably mounted within the mount frame on a plurality of linear guides extending perpendicular to the planar sealing surface of the flange, and the linear guides slidably extending through the filter bracket; and, The plurality of cams are configured to mechanically act on the one or more push plates to urge the filter bracket along the plurality of linear guides in a path perpendicular to the planar sealing surface of the flange.

4. The filter mount system of claim 3, wherein: The linear guide has a concentrically mounted compression spring arranged to be compressed as the filter carrier translates on the linear guide towards the planar sealing surface of the flange under the action of the cam on the push plate.

5. The filter mount system of claim 2, wherein: The manually operated single-acting actuation subsystem effects sealing engagement of the planar sealing surface of the filter with the planar sealing surface of the flange via one manual partial rotation of the handle about the common axis of the cam.

6. The filter mount system of claim 1 , wherein: The mount frame includes an interlock mechanism arranged to prevent movement of the filter holder perpendicular to the planar sealing surface of the flange if the filter is not fully inserted into the filter holder.

7. The filter mount system of claim 5, wherein: The interlocking mechanism comprises: an interlocking rod having a pin at each longitudinal end; two slots in the upper and lower end pieces of the mount frame and extending substantially parallel to the planar sealing surface of the flange; and, wherein each pin is attached to the mount frame by an extension spring arranged to retain the interlocking lever in a position that blocks movement of the filter bracket perpendicular to the planar sealing surface of the flange; and, wherein, when the filter is inserted into the filter holder, the two pins slide in the two slots and the filter pushes the interlocking rod out of a position where the interlocking rod blocks movement of the filter holder perpendicular to the planar sealing surface of the flange, so as to enable sealing engagement around the port by the planar sealing surface of the filter.

8. The filter mount system of claim 1 , wherein: The system includes at least two cooperating retaining devices provided on the mounting frame and the single-acting actuating subsystem, the retaining devices being arranged to retain the single-acting actuating subsystem in a state in which the planar sealing surface of the filter is sealingly engaged with the planar sealing surface of the flange when the retaining devices are engaged with each other.

9. The filter mount system of claim 1 , wherein: The controlled environment enclosure is a pharmaceutical isolator, and the port is an air exhaust port in fluid communication with a fluid dispensing interior of the controlled environment enclosure.

10. A method for sealing a filter in overlying alignment with a port of a controlled environment enclosure, the filter having a planar sealing surface peripherally defining a porous filter medium, the method comprising: providing a filter mount system attached to the enclosure about a planar sealing surface of a flange surrounding the port, wherein The filter mount system includes a manually operated single-acting actuation subsystem; The filter mount system includes a filter bracket for receiving the filter, wherein a planar sealing surface of the filter is constrained by the bracket to be parallel to the planar sealing surface of the flange; and, the filter carrier being constrained to translate perpendicular to the planar sealing surface of the flange by the action of the single-acting actuation subsystem; inserting the filter into the filter holder with the planar sealing surface of the filter parallel to the planar sealing surface of the flange such that the filter is positioned in overlying alignment with the port; and The planar sealing surface of the filter is sealingly engaged to the planar sealing surface of the flange by a single action manually applied to the single-acting actuation subsystem.

11. The method according to claim 10, wherein: The manually operated single-acting actuation subsystem comprises: a plurality of cams arranged to rotate in parallel planes about a common axis in a plane parallel to the planar sealing surface of the flange; and a handle rigidly connecting the plurality of cams to each other; and, wherein the single action comprises rotating the handle about the common axis of the cams with one manual partial rotation.

12. The method according to claim 10, wherein: The filter mount system includes an interlock mechanism that resists translation of the filter bracket perpendicular to the planar sealing surface of the flange; and, Inserting the filter includes fully inserting the filter into the filter holder, thereby forcing the interlock mechanism aside to allow movement of the filter holder.

13. The method according to claim 10, wherein: The filter mount system includes at least two cooperating retaining devices disposed on the mount frame and the manually operated single-acting actuation subsystem; and, Wherein, the method further includes engaging the retaining devices to each other to retain the manually operated single-acting actuation subsystem in a state in which the planar sealing surface of the filter is sealingly engaged with the planar sealing surface of the flange.

14. The method according to claim 10, wherein: The controlled environment enclosure is a pharmaceutical isolator.

15. The method according to claim 10, wherein The port is an exhaust port in fluid communication with the controlled environment enclosure.

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