Filter system for pharmaceutical filling isolator and method therefor

Abstract

The present invention relates to a system and method for mounting an exhaust filter to a pharmaceutical isolator, comprising a set of parallel cams joined by a rigid bar for urging a filter carriage containing a filter along parallel spring-loaded linear guide rods. The system engages the exhaust flange of a controlled environment enclosure with the exhaust filter under uniform lateral pressure. To prevent a seal failure if the exhaust filter is not properly seated on the filter carriage, an interlock bar prevents movement of the filter carriage along the linear guide rods if the exhaust filter is not fully inserted into the filter carriage. This system is employed in pharmaceutical filling machines that must maintain a sterile internal environment under a positive pressure differential.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application is an international patent application claiming priority under the PCT and U.S. Patent Act (35) §119(e) to U.S. Provisional Patent Application No. 63 / 445,068, filed February 13, 2023, the disclosure of which is incorporated herein by reference.

[0002] This disclosure relates to the medical field exemplified by IPC Class A61, and more particularly to apparatus and related methods for the sterilization and aseptic handling of pharmaceutical substances and pharmaceutical containers, particularly methods involving forming pharmaceutical products for administration to medical or veterinary patients. In one aspect, the present invention relates to maintaining proper sterility in conjunction with efficient processing using such apparatus and systems. [Background technology]

[0003] The SARS-CoV-2 virus pandemic at the beginning of the 21st century has led to increased environmental regulations for technological processes in the pharmaceutical industry. Every aspect of the industry's equipment, machinery, and processes is coming under stricter scrutiny. It has become clear to even the layman that the interior of a medical isolator box is as important to the environment outside the isolator as the environment itself is to the materials inside the isolator.

[0004] In the pharmaceutical industry, the filling of pharmaceutical substances into sterile pharmaceutical containers is carried out under strictly controlled sterile or aseptic conditions. Container filling equipment is typically installed and operated in a medical clean laboratory environment with a controlled atmosphere under strictly defined conditions. International organizations such as the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) have also developed detailed and rigorous specifications for medical-grade isolators to house filling equipment.

[0005] Clean laboratories housing filling equipment used in the pharmaceutical industry function under strictly defined conditions, but every effort must be made to ensure 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. For this reason, air entering the filling equipment from the clean laboratory environment is filtered. Similarly, the air exhausted from the equipment into the clean laboratory is also filtered by one or more exhaust filters.

[0006] In the prior art, exhaust filters for filling machines were typically manually installed onto the exhaust port of the machine's controlled environment enclosure. In the pharmaceutical industry, controlled environment enclosures are often referred to as "isolators." Installation is typically accomplished by manually attaching the filter to the isolator's exhaust port and then tightening multiple bolts or other fasteners located around the perimeter. If the filter is not installed correctly, the exhaust filter or the gasket sealing the exhaust filter to the isolator can become distorted, resulting in leaks. This typically requires the entire process to be stopped, the filter reattached and resealed, and sterility re-established within the isolator. This avoidable downtime, especially in the case of the SARS-CoV-2 virus, has significant implications for an industry that has had to manufacture billions of doses of vaccines filled into cartridges that are then loaded onto syringes.

[0007] Any measure to avoid or shorten interruptions in the pharmaceutical filling process is welcomed by the pharmaceutical industry.The present disclosure addresses the challenge of ensuring reliable and accurate installation of exhaust filters in medical isolators. Summary of the Invention [Problem to be solved by the invention]

[0008] In one aspect, a filter mounting system for mounting a filter having a planar sealing surface surrounding a periphery of a porous filter media is provided, the filter mounting system including: a mounting frame attachable to a periphery of the planar sealing surface of the flange; a manually operated single-action actuation subsystem; and a filter carriage for accommodating the filter, the filter carriage being constrained by the filter carriage so that the planar sealing surface of the filter is parallel to the planar sealing surface of the flange. The filter carriage is constrained by the single-action actuation subsystem to move within the mounting frame perpendicular to the planar sealing surface of the flange, thereby achieving sealing engagement between the planar sealing surface of the filter and the planar sealing surface of the flange, and positioning the filter overlapping the port.

[0009] The manually operated single-action actuation subsystem may include a plurality of cams arranged to rotate in parallel planes perpendicular to the planar sealing surface of the flange, and a handlebar 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 carriage may include one or more push plates having a plane parallel to the planar sealing surface of the flange. The filter carriage is movably mounted within the mounting frame on a plurality of linear guides extending perpendicular to the planar sealing surface of the flange and slidably extending through the carriage. The plurality of cams are arranged to mechanically act on the one or more push plates to urge the filter carriage along the plurality of linear guides on a path perpendicular to the planar sealing surface of the flange. The linear guides have concentrically mounted compression springs arranged to be compressed when the filter carriage moves on the linear guides toward the planar sealing surface of the flange due to the action of the cams on the push plates. The manually operated single action actuation subsystem achieves sealing engagement between the flat sealing surface of the filter and the flat sealing surface of the flange by manually rotating the handlebars one partial turn about the common axis of the cam.

[0010] The mounting frame may include an interlock mechanism that prevents the filter carriage from moving perpendicular to the flat sealing surface of the flange when the filter is incompletely inserted into the filter carriage. The interlock system may include an interlock bar having a peg at each longitudinal end and two slots in the upper and lower end pieces of the mounting frame that extend substantially parallel to the flat sealing surface of the flange. Each peg is attached to the mounting frame by an extension spring that is positioned to hold the interlock bar in a position that prevents movement of the filter carriage perpendicular to the flat sealing surface of the flange. When a filter is inserted into the filter carriage, the two pegs slide within the two slots, and the filter pushes the interlock bar out of its position preventing movement of the filter carriage perpendicular to the flat sealing surface of the flange, allowing the flat sealing surface of the filter to seal around the port.

[0011] The filter mounting system may include at least two cooperating retention devices disposed on the mounting frame and the manually operated single-action actuation subsystem, which retention devices are configured, when engaged with each other, to hold the manually operated single-action actuation subsystem with the planar sealing surface of the filter in sealing engagement with the planar sealing surface of the flange. The controlled environment enclosure may be a pharmaceutical isolator, and the port may be an air exhaust port in fluid communication with the fluid distribution interior of the controlled environment enclosure.

[0012] In a further aspect, a method for sealing a filter having a planar sealing surface overlapping a port of a controlled environment enclosure and surrounding a periphery of a porous filter media is provided, the method including providing a mechanical filter mounting system secured to the enclosure around the planar sealing surface of a flange surrounding the port. The filter mounting system includes a manually operated single-action actuation subsystem and a filter carriage housing the filter, wherein the planar sealing surface of the filter is constrained by the filter carriage to be parallel to the planar sealing surface of the flange and the filter carriage is constrained to move perpendicular to the planar sealing surface of the flange under the action of the single-action actuation subsystem. The filter is inserted into the filter carriage so that the planar sealing surface of the filter is parallel to the planar sealing surface of the flange, thereby positioning the filter in overlapping position with the port and bringing the planar sealing surface of the filter into sealing engagement with the planar sealing surface of the flange by a single action manually applied to the single-action actuation subsystem.

[0013] The manually operated single-action 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 bar rigidly connecting the plurality of cams to one another, such that a single action of the seal may include manually rotating the handle bar one partial turn about the common axis of the cams.

[0014] The filter mount may include an interlock mechanism that prevents the filter carriage from moving perpendicular to the planar sealing surface of the flange, and inserting the filter may include fully inserting the filter into the filter carriage, thereby displacing the interlock mechanism and allowing movement of the carriage.

[0015] The filter mounting system may include at least two cooperating retention devices disposed on the frame of the mount and the manually operated single-action actuation subsystem, respectively, and the method may further include engaging the retention devices with each other to hold the manually operated single-action actuation subsystem with the planar sealing surface of the filter in sealing engagement with the planar sealing surface of the flange. [Brief explanation of the drawings]

[0016] The above and other features and objects of the present invention, as well as the manner in which they are accomplished, will become more apparent, and the invention itself will be better understood, by referring to the following description of the embodiments of the invention taken in conjunction with the accompanying drawings.

[0017] [Figure 1] FIG. 1 is a schematic diagram of one embodiment of a pharmaceutical filling machine with a controlled environment enclosure. [Figure 2] 2 shows a schematic diagram of an exhaust filter suitable for use in the device of FIG. 1; [Figure 3] 3 shows an exhaust filter mount for attaching the exhaust filter of FIG. 2 to the device of FIG. 1; [Figure 4] 4 shows the exhaust filter mount of FIG. 3 in a reverse orientation with the exhaust filter of FIG. 2 attached to the filter carriage of the exhaust filter mount. [Figure 5A] 4 shows the exhaust filter mount of FIG. 3 with the filter carriage in the retracted position and the filter mount in the open position. [Figure 5B] The exhaust filter mount of FIG. 3 is shown in a closed state with the filter carriage in the closed position and the exhaust filter of FIG. 2 sealed to the exhaust flange of the controlled environment enclosure of FIG. 1. [Figure 6] 1 shows a flow diagram of a method for sealing an exhaust filter to an exhaust flange of a controlled environment enclosure.

[0018] Corresponding reference characters indicate corresponding parts throughout the various views. While the drawings depict embodiments of the present invention, they are not necessarily to scale and certain features may be exaggerated to more clearly illustrate and explain the present invention. The illustrations set forth herein illustrate one embodiment of the present invention in one form, and such illustrations should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION OF THE INVENTION

[0019] 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 its teachings.

[0020] FIG. 1 illustrates a pharmaceutical filling machine 100 including a controlled environment enclosure 110. The controlled environment enclosure 110 may be a sterile-sealable medical or pharmaceutical isolator capable of sterilizing and maintaining the interior in a sterile state. The enclosure 110 may include a pneumatic control subsystem (not shown) for controlling the air pressure within the enclosure 110. The pneumatic control subsystem may include appropriate pumps and valves. Suitable pressure control subsystems are well known to those skilled in the art. The controlled environment enclosure 110 may house a variety of complex mechanical and servomechanical devices used to manipulate pharmaceutical containers and their closures. The enclosure 110 may house a variety of mechanical and servomechanical devices for operating at least one pharmaceutical filling needle used to administer the pharmaceutical. The pharmaceutical is typically, but not limited to, a liquid. An electronic control system for controlling or programming operations within the enclosure 110 may be mounted externally to the enclosure. For this reason, FIG. 1 shows a general-purpose controller 120 connected to the enclosure 110 and various devices within the enclosure 110. The exhaust filter mount 300, described in more detail below with respect to FIGS. 3, 4, 5A, and 5B, seals the exhaust filter 200 to a flange surrounding the enclosure 110's port 150 in a recess 130 on the exterior of the enclosure 110. The exhaust filter 200 is positioned to filter air exhausted from the enclosure 110 through the port 150. The recess 130 may be closed by a door (not shown for clarity). When the door is closed, it is airtightly sealed against the enclosure 110 frame, and air exhausted from the filter attached to the exhaust filter mount 300 is exhausted through a vent 140 shown on the bottom of the enclosure 110. The exhaust air from the vent 140 may be recirculated within the enclosure 110 via an appropriate inlet filter or exhausted to a clean laboratory environment. The apparatus 100 may include a plurality of exhaust filter mounts 300 with filters 200 .

[0021] The terms "aseptic" and "sterilize," as well as their derivatives, are understood herein as follows: Establishing a sterile condition inside a container is understood to mean establishing a sterile condition throughout the atmosphere inside the container as well as in substantially all exposed interior surfaces of the container. This includes the surfaces of all items, containers, subsystems, etc. that are exposed to the enclosure's internal atmosphere. If extremely narrow or minute gaps exist inside the enclosure, the sterilizing gas or vapor may not completely penetrate such narrow areas. Therefore, the actual degree of sterilization may not be complete. This is recognized by both the industry and industry standards. In this application, the act of "maintaining a sterile condition inside the container" and the act of "sterilizing the inside of the container" have the same meaning.

[0022] Introducing an item whose surface is not properly sterilized into a sterile enclosure destroys the existing sterility within the enclosure. Conversely, introducing a sterile or aseptic item into an enclosure whose interior is not sterile does not render the enclosure sterile; in fact, it only destroys the sterility of the surface of the item being introduced. Similarly, introducing filtered air, even if it has been purified of all biological components, into an unsterile container does not sterilize the container or bring it to a level of sterility acceptable in the pharmaceutical industry, because the introduction of such air does not sterilize the interior of the enclosure. The result is contamination of the filtered air with active biological species that inhabit the interior of the unsterile enclosure.

[0023] For clarity and completeness, it should be noted that the term "sterile" in the art may be used in connection with the introduction of medicinal fluids into the body in controlled containers through sterile tubing. In such cases, the term "sterile" in the art refers to the conditions within the tubing or the fact that the medicinal fluid can be filtered to an appropriate degree. This does not render the interior of the container in question sterile or aseptic. The sterility in such cases is limited to the interior of the tubing through which the medicinal product flows. While such fluids are often highly filtered, such filtration only affects the interior of the specific tubing and does not sterilize the interior of the enclosure.

[0024] In some prior art systems, containers introduced into an enclosure for filling with pharmaceutical products are passed through a sterilization subsystem, which kills any biological species on the container. If such a sterilized container is introduced into a non-sterile enclosure, the biological species contained within the enclosure will attach to the previously sterile container, causing the container to lose its sterility.

[0025] 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 because they use laminar flow hoods and all quality HEPA (high-efficiency particulate air) and ULPA (ultra-low particulate air) filters without a reliable means of rendering the room surfaces sterile or aseptic. Both the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) have standards for clean rooms. These standards detail the allowable particle content per volume of air within a clean room facility, each with different criteria. Neither of these standards addresses the issue of biological species present on surfaces within the room. This demonstrates that atmosphere and airflow control alone cannot render an enclosure sterile. Conversely, an enclosure cannot be rendered sterile by sterilizing only its interior surfaces.

[0026] The 2008 Guidelines for Disinfection and Sterilization in Healthcare Facilities by Rutala et al., U.S. Centers for Disease Control and Prevention, provides an overview of sterilization mechanisms and methods and is incorporated herein by reference in its entirety as if fully disclosed herein. The specification focuses specifically on sterilization mechanisms within the enclosure, i.e., mechanisms that sterilize both the interior surface and the atmosphere of the enclosure. Given the requirements, steam-based sterilization methods are most suitable. These include, but are not limited to, treatment with superheated steam, hydrogen peroxide vapor, ozone, nitrogen dioxide, ethylene oxide, glutaraldehyde vapor, or other suitable sterilizing gases and vapors. One method suitable for the present invention involves rinsing the container with ozone after sterilization with hydrogen peroxide vapor and before using the container to fill pharmaceutical containers.

[0027] As used herein, the term "decontamination" refers to the process of removing or inactivating contaminants to acceptable levels, including, but not limited to, viruses, bacteria, spores, prions, molds, yeasts, proteins, pyrogens, endotoxins, etc. As used herein, "decontamination" includes both sterilization (i.e., the destruction of all microorganisms, including bacterial spores, typically to a survival probability of less than 1:10) and disinfection (i.e., the destruction and removal of specific types of microorganisms).

[0028] To achieve an appropriate level of sterility, enclosure 110 may be hermetically sealed. In one embodiment, the hermetic seal provided by enclosure 110 is sufficient to meet predetermined requirements based on ISO standard ISO 10648-2, "Containment Enclosures Part 2: Classification by Leak Tightness and Associated Test Methods." Specifically, the sealing is preferably sufficient to meet Class 3, with Class 2 being more preferred, and Class 1 being even more preferred. In another embodiment, the hermetic sealing provided by enclosure 100 is sufficient to meet predetermined requirements in accordance with the technical report entitled "Design and Validation of Isolator Systems for the Manufacturing and Testing of Medical Products," PDA Journal of Pharmaceutical Science and Technology Technical Report No. 34 (September / October 2001). The disclosures of both of these documents are incorporated herein by this reference as if fully set forth herein.

[0029] FIG. 2 is a schematic diagram of an exhaust filter 200 suitable for use with the device 100. The filter includes a filter element 210 constructed from, for example, but not limited to, porous PTFE or fiberglass. The filter 200 may further include a filter frame 220 that houses the porous filter element (or filter media) 210. A compressible gasket 230 is preferably disposed on a planar air inlet face 240 of the filter element 210. The planar air inlet face 240 is indicated by solid diagonal lines. The gasket 230 surrounds the porous filter element 210 of the filter 200, forming a planar sealing surface for the filter 200. The opposite, external air outlet face 260 of the filter 200 is indicated by dashed diagonal lines. Two brackets 250 are attached to opposite ends of the filter frame 220. One bracket 250 is located at the distal end of the exhaust filter 200 and is hidden by the filter 200 and is therefore indicated by dashed lines. Bracket 250 is used to guide exhaust filter 200 when exhaust filter 200 is manually inserted into filter carriage 310 (see Figures 3 and 5A).

[0030] When exhaust filter 200 is mounted to enclosure 110 by exhaust filter mount 300, it is positioned to overlap port 150, and gasket 230, which is the flat sealing surface of filter 200, sealingly engages flat sealing surface 170 of flange 160 (see FIG. 4 ). Air inlet face 240 is exposed to the interior of enclosure 110 and thereby exposed 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 enclosure 110 as described above. Therefore, filter 200 must be compatible with these gases and vapors and the processes in which they are used. In the embodiment shown in FIG. 2 , exhaust filter 200 has a rectangular shape. In other embodiments, the exhaust filter can have a variety of suitable shapes, including, but not limited to, circular.

[0031] Figure 3 shows the exhaust filter mount 300 in more detail without the exhaust filter 200 installed. The entire exhaust filter mount 300 is permanently mounted within the recess 130 on the exterior of the enclosure 110. In one embodiment shown in Figure 1, the exhaust filter mount 300 is oriented with its longest dimension vertical. In other embodiments, the exhaust filter mount 300 may be oriented in other orientations that allow the gasket 230 to sealingly engage the exhaust flange 160 on the exterior of the enclosure 110. See Figures 4, 5A, and 5B, described below, for details of the exhaust flange 160.

[0032] When a door (not shown) to the recess 130 on the outside of the enclosure 110 is closed, exhaust air leaving the enclosure 110 through the exhaust filter 200 is exhausted through the vent 140. In this process, the filtering action of the exhaust filter 200 occurs.

[0033] The exhaust filter mount 300 includes a movable filter carriage 310. The filter carriage 310 includes two push plates 312 at each longitudinal end thereof. These push plates 312 are configured to move along a plurality of linear guides 322 within the mount frame 320 of the exhaust filter mount 300, while simultaneously compressing a plurality of corresponding springs 324 arranged concentrically on the corresponding linear guides 322. Four linear guides 322 are shown in FIG. 3, each with one spring 324 arranged concentrically. For clarity, only one linear guide 322 and its corresponding spring 324 are shown at the bottom of the mount frame 320. Details of the linear guides 322 and springs 324 can be seen in FIGS. 5A and 5B.

[0034] The filter carriage 310 is urged along a path of movement along a linear guide 322 within the mount frame 320 by a cam subsystem 330, which includes two cams 332 rigidly coupled to each other by a rigid handlebar 334. The cam subsystem 330 is herein referred to as a "manually operated single-action actuation subsystem." One of the cams 332, connected to the handlebar 334, is hidden by a portion of the mount frame 320 and is therefore not visible in FIG. 3. Each of the cams 332 rotates about a cam shaft 336 that is parallel to the handlebar 334. When the exhaust filter 200 is mounted in the exhaust filter mount 300, the cam shaft 336 is parallel to the planar sealing surface of the exhaust filter 200 (the gasket 230 in the case of the filter in FIG. 2). Therefore, the cam shaft 336 is also parallel to the exhaust flange 160, which is shown in FIGS. 5A and 5B, described below. FIGS. 3, 4, 5A, and 5B show different views of the cams 332 acting on the push plate 312. The push plate 312 is provided with a suitable hole 314 for sliding along a linear guide 322 and is configured to compress a spring 324 under the action of a cam 332 .

[0035] Figure 4 shows a view of exhaust filter mount 300 from the opposite direction from Figure 3, with exhaust filter 200 mounted to filter carriage 310 of exhaust filter mount 300. In Figure 4, gasket 230 of exhaust filter 200 faces away from the viewer. Both cams 332 are visible in this view of exhaust filter mount 300; however, linear guide 322 and spring 324 are not visible in this view. Figure 4 also shows port 150 of enclosure 110 surrounded by flange 160, which has a planar sealing surface 170 against which filter 200 is configured to seal.

[0036] FIG. 5A is a top view of the exhaust filter mount 300, showing the filter carriage 310 pulled away from the exhaust flange 160 around the port 150. The spring 324 around the linear guide 322 is relaxed. The exhaust filter 200 is shown not fully inserted into the filter carriage 310. FIG. 5B shows the same view of the exhaust filter mount 300 with the filter carriage 310 in the closed position and the spring 324 around the linear guide 322 compressed. The exhaust filter 200 is clamped and pressurized against the exhaust flange 160 of the enclosure 110. The port 150 of the enclosure 110 is shown in dashed lines in both FIGS. 5A and 5B.

[0037] The handle bar 334 can be rotated (counterclockwise in FIGS. 5A and 5B ) about a cam shaft 336 to retract the filter carriage 310, thereby moving the exhaust filter 200 away from the exhaust flange 160 of the enclosure 110. This is typically done to replace the exhaust filter 200 in the filter carriage 310. To seal the exhaust filter 200 to the enclosure 110, the handle bar 334 can be rotated in the opposite direction (clockwise in FIG. 5B ). This rotation urges the filter carriage 310 along the linear guides 322, compressing the springs 324. This action continues until the gasket 230 seals against the exhaust flange 160. The springs 324 can be configured such that when the gasket 230 seals against the exterior of the enclosure 110, the springs 324 are sufficiently compressed to generate sufficient force to push the gasket 230 away from the exhaust flange 160. Thus, as shown in FIG. 3 , cooperating retention devices 326, 338 may be disposed on the mount frame 320 and the cam subsystem 330, respectively, to maintain the cam subsystem 330 in a closed position when the apparatus 100 is in use, sealing the exhaust filter 200 to the exterior of the enclosure 110. In FIG. 3 , the cooperating retention devices 326, 338 form an elbow latch therebetween. In other embodiments, alternative retention devices may be employed. Releasing elements of the retention devices 326, 338 and rotating the handlebar 334 to the open position moves the filter carriage 310 and exhaust filter 200 away from the exhaust flange 160, facilitating removal of the exhaust filter 200.

[0038] The arrangement of exhaust filter mount 300 and its particular mode of function allows exhaust filter 200, mounted on filter carriage 310, to sealingly engage exhaust flange 160 on the exterior of enclosure 110 with uniform pressure across the entire surface of gasket 230, which serves as the planar sealing surface of filter 200. This apparatus, mechanism, and method effectively eliminates leakage problems associated with conventional manual installation of exhaust filters.

[0039] Pharmaceutical filling apparatus 100 is configured to prevent the servo-mechanical filling device within enclosure 110 from turning on unless a positive atmospheric pressure is detected within the enclosure relative to the external environment surrounding apparatus 100. To this end, exhaust filter mount 300 may be equipped with an interlock mechanism. In the embodiments of FIGS. 3, 4, 5A, and 5B, exhaust filter mount 300 includes an interlock bar 340 that engages with mount frame 320 to prevent exhaust filter 200 from sealingly engaging exhaust flange 160 of enclosure 110 and establishing a positive pressure differential unless interlock bar 340 is properly positioned. Additionally, interlock bar 340 will not be positioned in the required position unless exhaust filter 200 is fully and correctly inserted into filter carriage 310. Interlock bar 340 blocks the path of filter carriage 310 along multiple linear guides 322 unless exhaust filter 200 is fully inserted into filter carriage 310. When the path of the filter carriage 310 is blocked in this manner, the exhaust filter 200 cannot seal to the exhaust flange 160 of the enclosure 110, positive pressure cannot be established within the enclosure 110, and the entire device 100 cannot be electrically turned on.

[0040] To this end, the interlock bar 340 includes two pegs 342, one at each longitudinal end of the interlock bar 340, extending longitudinally from each end of the interlock bar 340 and extending along the same longitudinal axis. The pegs 342 slide within two corresponding slots 344, one at each longitudinal end of the mounting frame 320. The slots 344 precisely overlap each other along the longitudinal axis of the mounting frame 320. Each peg 342 is provided with an extension spring 346 attached to a corresponding fixed point at each longitudinal end of the mounting frame 320. Thus, the springs 346 are configured to prevent the interlock bar 340 from blocking the path of the filter carriage 310 along the linear guides 322 unless the exhaust filter 200 is fully inserted into the filter carriage 310. In FIG. 5A, the interlock bar 340 (hidden in this view by the mounting frame 320, but visible in FIG. 3) is not yet engaged, and the corresponding peg 342 remains in its rightmost position within the slot 344. The spring 346 is accordingly shown in its relaxed state. When the exhaust filter 200 is fully inserted into the filter carriage 310, it stops against a stop 348 on the filter carriage 310. Before reaching the stop 348, the exhaust filter 200 presses against the interlock bar 340, which pushes the interlock bar 340 laterally, as indicated by arrow 349 in FIG. 3. The slot 344 is configured long enough to allow the exhaust filter 200 to fully push the interlock bar 340 out of the way of the filter carriage 310, allowing the filter carriage 310 to advance in the direction of arrow 319 in FIG. 3 and seal the exhaust filter 200 against the planar sealing surface 170 of the exhaust flange 160 of the enclosure 110.

[0041] The above description provides a filter mounting system 300 for mounting a filter 200 having a flat sealing surface in the form of a gasket 230 surrounding a periphery of a porous filter media 210 in a location that overlaps a port 150 of a controlled environment enclosure 110, the enclosure 110 including a flange 160 having a flat sealing surface 170 surrounding the port 150, the filter mounting system 300 including a mounting frame 320 mounted around the flat sealing surface 170 of the flange 160, a manually operated single-action actuation subsystem 330, and a filter carriage 310. and a filter carriage 310 for receiving a filter 200 having a flat sealing surface in the form of a gasket 230 constrained by a single-action actuation subsystem 330 to move within a mount frame 320 perpendicular to the flat sealing surface 170 of the flange 160, thereby achieving sealing engagement between the flat sealing surface (gasket 230) of the filter 200 and the flat sealing surface 170 of the flange 160, and positioning the filter 200 so that it overlaps the port 150.

[0042] The manually operated single-action actuation subsystem 330 includes a plurality of cams 332 arranged to rotate in parallel planes perpendicular to the planar sealing surface 170 of the flange 160, and a handle bar 334 rigidly connecting the plurality of cams 332 to one another, the cams 332 configured to rotate about a common axis in a plane parallel to the planar sealing surface 170 of the flange 160. The filter carriage 310 may include one or more push plates 312 having a plane parallel to the planar sealing surface 170 of the flange 160. The filter carriage 310 is movably mounted within the mount frame 320 on a plurality of linear guides 322 extending perpendicular to the planar sealing surface 170 of the flange 160 and slidably passing through the filter carriage 310, the plurality of cams 332 configured to mechanically act on the one or more push plates 312 to move the filter carriage 310 along the plurality of linear guides 322 on a path perpendicular to the planar sealing surface 170 of the flange 160. The linear guide 322 has a concentrically mounted compression spring 324 that is compressed as the filter carriage 310 moves on the linear guide 322 toward the planar sealing surface 170 of the flange 160 under the action of a cam 332 on the push plate 312. A manually operated single-action actuation subsystem 330 effects sealing engagement between the planar sealing surface of the filter 200 and the planar sealing surface 170 of the flange 160 by manually rotating a handle bar 334 one partial turn about a common axis 336 of the cam 332.

[0043] Mount frame 320 may include an interlock mechanism (elements 340, 342, 344, and 346 in FIGS. 3 and 5A and 5B ) configured to prevent movement of filter carriage 310 perpendicular to planar sealing surface 170 of flange 160 if filter 200 is incompletely inserted into filter carriage 310. The interlock system includes an interlock bar 340 having one peg 342 at each longitudinal end and slots 344 in the upper and lower end pieces of mount frame 320, extending substantially parallel to planar sealing surface 170 of flange 160, each peg 342 attached to mount frame 320 by an extension spring 346 arranged to hold interlock bar 340 in a position that prevents movement of filter carriage 310 perpendicular to planar sealing surface 170 of flange 160. When filter 200 is inserted into filter carriage 310 and filter 200 pushes interlock bar 340 out of the position where interlock bar 340 prevents movement of filter carriage 310 perpendicular to flat sealing surface 170 of flange 160, pegs 342 slide within each slot 344, allowing sealing engagement by the flat sealing surface (gasket 230) of filter 200 around port 150.

[0044] The filter mounting system 300 comprises at least two cooperating retention devices 326, 338 disposed on a mounting frame 320 and a manually operated single-action actuation subsystem 330, respectively, which retention devices 326, 338 are configured to retain the manually operated single-action actuation subsystem 330 when the retention devices 326, 338 are engaged with one another, with the flat sealing surface (gasket 230) of the filter 200 in sealing engagement with the flat sealing surface 170 of the flange 160. The controlled environment enclosure 110 is a pharmaceutical isolator, and the port 150 is an exhaust port in fluid communication with the fluid distribution interior of the controlled environment enclosure.

[0045] In one aspect, a method

[0500] for sealing a filter 200 having a planar sealing surface (e.g., gasket 230) that borders a periphery of a porous filter media 210 to overlap a port 150 of a controlled environment enclosure 110, the method

[0500] comprising the step

[0510] of providing a mechanical filter mounting system 300 secured to the enclosure 110 around a planar sealing surface 170 of a flange 160 that surrounds the port 150, the filter mounting system 300 comprising a manually operated single-action actuation subsystem 330 and a filter carriage 310 for receiving the filter 200, the planar sealing surface (e.g., gasket 230) of the filter 200 being secured to the flange 160 by the filter carriage 310. The method includes a step

[0510] of constraining the filter 200 to be parallel to the flat sealing surface 170 of the flange 160, and the filter carriage 310 being constrained to move perpendicular to the flat sealing surface 170 of the flange 160 by the operation of the single-action actuation subsystem 330; a step

[0520] of inserting the filter 200 into the filter carriage 310 and positioning the filter 200 so that the flat sealing surface (gasket 230) of the filter 200 is parallel to the flat sealing surface 170 of the flange 160 and overlapping the port; and a step

[0530] of sealingly engaging the flat sealing surface (gasket 230) of the filter 200 with the flat sealing surface 170 of the flange 160 by a single action manually applied to the single-action actuation subsystem 330.

[0046] The manually operated single action actuation subsystem 330 may include a plurality of cams 332 arranged to rotate in parallel planes about a common axis 336 in a plane parallel to the planar seal surface 170 of the flange 160, and a handle bar 334 rigidly connecting the plurality of cams 332 to one another, so that a single action

[0520] of the seal may involve manually rotating the handle bar 334 partially once about the common axis 336 of the cams 332.

[0047] The filter mounting system 300 may include an interlock mechanism that prevents the filter carriage from translating in a direction perpendicular to the planar sealing surface 170 of the flange 160, and the step of inserting the filter 200

[0520] may include fully inserting the filter 200 into the filter carriage 310, thereby displacing the interlock mechanism and allowing the filter carriage 310 to move.

[0048] The filter mount system 300 may include at least two cooperating holding devices 338, 326 respectively disposed on the frame 320 of the mount 300 and the manually operated single-action actuating subsystem 330, and the method

[0500] may further include engaging the holding devices 338, 326 with each other to hold the manually operated single-action actuating subsystem 330 with the flat sealing surface (gasket 230) of the filter 200 sealingly engaged with the flat sealing surface 170 of the flange 160.

[0049] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The 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 additional elements in addition to those shown and described. However, the inventors also contemplate examples that include only those elements shown and described.

[0050] All publications, patents, and patent documents referenced herein are incorporated herein by this reference in their entirety, as if each individual document were incorporated by reference. If there is a conflict between the usage of this specification and the document incorporated by reference, the usage of the incorporated reference shall be deemed to supplement the usage of this specification. If the conflict is not resolved, the usage of this specification shall prevail.

[0051] As used herein, the terms "a" or "an" are used in the sense of including one or more, as commonly used in patent documents, independently of other instances or uses of "at least one" or "one or more." The term "or" is used herein to refer to a non-exclusive "or," such as "A or B" including "A but not B," "B but not A," or "A and B," unless otherwise noted. In the appended claims, the terms "comprises" and "in which" are used as plain English translations of the terms "comprises" and "wherein," respectively. Also, in the following claims, the terms "comprises" and "comprising" are open-ended, meaning that systems, devices, articles, or processes that include elements other than those recited after these terms in a claim are still deemed to be within the scope of that claim. Furthermore, in the following claims, the terms "first," "second," "third," etc., are used merely as labels and are not intended to impose numerical requirements on their subject matter.

[0052] The foregoing description is intended to be illustrative, not limiting. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Furthermore, other embodiments may be adopted by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided in accordance with 37 C.F.R. §1.72(b) to enable the reader to quickly grasp the contents of the technical disclosure. This specification has been submitted with the understanding that it will not interpret or limit the scope or meaning of the claims. Moreover, in the foregoing Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as meaning that a disclosed feature not defined in a claim is essential to any claim. Rather, inventive subject matter may lie in fewer than all features of a particular disclosed embodiment. Accordingly, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as an independent embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0053] While this invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of the disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover departures from the disclosure within known or customary practice in the art to which this invention pertains. [Explanation of symbols]

[0054] 100 Pharmaceutical filling equipment 110 Controlled Environment Enclosure 120 General-purpose controller 130 recess 140 Ventilation 150 ports 160 flange 170 Flat sealing surface 200 Exhaust Filter 210 Porous filter element 220 filter frame 230 Gasket 240 air inlet surface 300 Exhaust Filter Mount 310 Filter Carriage 312 Push Plate 320 Mounting Frame 322 Linear Guide 324 Spring 326, 338 holding device 330 Cam Subsystem 332 Cam 334 Handlebar 336 Camshaft 340 Interlocking Bar 342 Peg 344 Slots 348 Stopper

Claims

1. 1. A filter mounting system for mounting a filter having a planar sealing surface surrounding a periphery of a porous filter media so as to overlap a port of a controlled environment enclosure, the controlled environment enclosure including a flange having a planar sealing surface surrounding the port, the filter mounting system comprising: The filter mount system comprises: a mount frame mountable around the planar sealing surface of the flange; a manually operated single action actuation subsystem; a filter carriage for accommodating the filter, the filter's flat sealing surface being constrained by the filter carriage to be parallel to the flat sealing surface of the flange; Including, the filter carriage is constrained by the action of the single-action actuation subsystem to move within the mount frame perpendicular to the flat sealing surface of the flange, achieving sealing engagement between the flat sealing surface of the filter and the flat sealing surface of the flange, and positioning the filter overlapping the port.

2. 10. The filter mounting system of claim 1, wherein the single-action 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 bar rigidly connecting the cams to one another, the cams configured to rotate about a common axis in a plane parallel to the planar sealing surface of the flange.

3. the filter carriage includes one or more push plates having a flat surface parallel to the flat sealing surface of the flange; the filter carriage is movably mounted within the mount frame on a plurality of linear guides extending perpendicular to the planar sealing surface of the flange, the linear guides slidably extending through the filter carriage; 3. The filter mounting system of claim 2, wherein the plurality of cams are arranged to mechanically act on one or more push plates to urge the filter carriage along the plurality of linear guides on a path perpendicular to a planar sealing surface of the flange.

4. 4. The filter mounting system of claim 3, wherein the linear guide includes a concentrically mounted compression spring positioned to be compressed as the filter carriage moves on the linear guide toward the planar sealing surface of the flange due to action of a cam on the push plate.

5. 3. The filter mounting system of claim 2, wherein the manually operated single-action actuation subsystem effects sealing engagement between the planar sealing surface of the filter and the planar sealing surface of the flange by manually rotating the handlebar partially through one turn about the common axis of the cam.

6. 2. The filter mounting system of claim 1, wherein the mounting frame includes an interlocking mechanism positioned to prevent movement of the filter carriage perpendicular to a planar sealing surface of the flange when the filter is incompletely inserted into the filter carriage.

7. the interlocking mechanism comprises an interlocking bar having a peg at each longitudinal end and two slots in the upper and lower end pieces of the mounting frame, the slots extending substantially parallel to the planar sealing surfaces of the flanges; each peg attached to the mounting frame by an extension spring positioned to hold an interlock bar in a position that prevents movement of the filter carriage perpendicular to the planar sealing surface of the flange; 6. The filter mounting system of claim 5, wherein when the filter is inserted into the filter carriage, the two pegs slide within the two slots and the filter pushes the interlock bar out of a position where the interlock bar prevents movement of the filter carriage perpendicular to the flat sealing surface of the flange, thereby allowing sealing engagement by the flat sealing surface of the filter around the port.

8. 2. The filter mounting system of claim 1, comprising the mounting frame and at least two cooperating retention devices disposed on the single-action actuation subsystem, the retention devices configured to hold the single-action actuation subsystem in a predetermined state in which a flat sealing surface of the filter is in sealing engagement with a flat sealing surface of the flange when the retention devices are engaged with each other.

9. 10. 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 distribution interior of the controlled environment enclosure.

10. 1. A method of sealing a filter, wherein the filter has a planar sealing surface surrounding a periphery of a porous filter media and is aligned to overlap a port of a controlled environment enclosure, comprising: A filter mounting system secured to an enclosure around a planar sealing surface of a flange surrounding a port, comprising: the filter mounting system includes a manually operated single-action actuation subsystem; The filter mount system includes a filter carriage for accommodating a filter, wherein a flat sealing surface of the filter is constrained by the filter carriage to be parallel to a flat sealing surface of the flange; providing a filter mounting system, wherein the filter carriage is constrained to move perpendicular to a planar sealing surface of the flange under the action of the single-action actuation subsystem; inserting the filter into the filter carriage and aligning the filter with the port, with the flat sealing surface of the filter parallel to the flat sealing surface of the flange; sealingly engaging a planar sealing surface of the filter with a planar sealing surface of the flange by a single manually applied action of the single-action actuation subsystem; A method of sealing a filter comprising:

11. the manually operated single action actuation subsystem comprising: 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; a handlebar rigidly connecting the cams to one another; Equipped with The method of claim 10, wherein the single action comprises manually rotating the handlebars partially once about the common axis of the cams.

12. the filter mounting system includes an interlock mechanism that prevents the filter carriage from moving perpendicular to the planar sealing surface of the flange; 11. The method of claim 10, wherein inserting the filter comprises fully inserting the filter into the filter carriage, thereby displacing the interlock mechanism and allowing movement of the filter carriage.

13. the filter mounting system includes at least two cooperating retention devices disposed on a frame of the mount and on the manually operated single-action actuation subsystem; 11. The method of claim 10, further comprising engaging the retaining devices to hold the manually operated single-action actuation subsystem with a flat sealing surface of the filter in sealing engagement with a flat sealing surface of the flange.

14. 11. The method of claim 10, wherein the controlled environment enclosure is a pharmaceutical isolator.

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

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