# US 12,111,329 B2 · Method for protecting and unprotecting the fluid path in a controlled environment enclosure > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,111,329 B2 - Document ID: US12111329B2 - Status: Granted - Kind: B2 - Application number: 17/691,258 - Filed: 2022-03-10 - Published: 2022-06-23 - Granted: 2024-10-08 - Earliest claimed: 2015-12-10 - Assignees: Vanrx Pharmasystems Inc. - Applicants: Vanrx Pharmasystems Inc. - Inventors: Christopher A. Procyshyn; Marcin Cichy - Web page: https://patentgrep.com/patent/US12111329B2 ## CPC - G01N 35/10: Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)} - A61J 1/12: with means for holding samples of contents - A61J 1/14: Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00) - A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe - A61L 2/07: Steam - A61L 2/16: using chemical substances - A61L 2/24: Apparatus using programmed or automatic operation - B01L 1/025: {Environmental chambers} - B01L 1/04: Dust-free rooms or enclosures - B01L 3/02: Burettes; Pipettes - B25J 21/00: Chambers provided with manipulation devices (constructional features of the mounting of the manipulator in the wall B25J1/08 {; glove-boxes for nuclear applications G21F7/04}) - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - B65B 3/04: Methods of, or means for, filling the material into the containers or receptacles - B65B 55/12: Sterilising contents prior to, or during, packaging - C12M 29/00: {Means for introduction, extraction or recirculation of materials, e.g. pumps (pumps per se F04B)} - C12M 37/02: {Filters} - C12M 41/14: {Incubators; Climatic chambers (per se B01L1/00)} - G01N 35/00029: {provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence)} - G01N 35/0099: {comprising robots or similar manipulators (robots per se B25J)} - B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details - B01L 2200/0689: Sealing - B01L 2200/141: Preventing contamination, tampering - B01L 2300/0609: Holders integrated in container to position an object - B01L 2300/0832: cylindrical, tube shaped - B01L 2400/0487: fluid pressure, pneumatics - G01N 2035/00148: {Test cards, e.g. Biomerieux or McDonnel multiwell test cards} - G01N 2035/00277: {Special precautions to avoid contamination (e.g. enclosures, glove- boxes, sealed sample carriers, disposal of contaminated material)} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B25J: MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES ({manipulators specially adapted for use in surgery A61B34/70; manipulators used in cleaning hollow articles B08B9/04}; manipulators associated with rolling mills B21B39/20; manipulators associated with forging machines B21J13/10; {manipulators associated with picking-up and placing mechanisms B23P19/007}; means for holding wheels or parts thereof B60B30/00; {vehicles with ground-engaging propulsion means, e.g. walking members B62D57/02, B62D57/032; devices for picking-up and depositing articles or materials between conveyors B65G47/90, B65G47/91; manipulators with gripping or holding means for transferring packages B65H67/065}; cranes B66C; {manipulators used in the protection or supervision of pipe-line installations F17D5/00; walking equipment adapted for nuclear steam-generators F22B37/006}; manipulators specially adapted for, or associated with, nuclear reactors G21C; {apparatus used for handling wafers during manufacture or treatment of semiconductor H10P72/50}) - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS} ## Abstract A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path and a swab within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated. The apparatus allows the fluid path to be unprotected without the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated. In some embodiments the fluid path comprises a fill needle that can removably and aseptically be sealed with a disposable monolithic injection moulded polymeric fill needle sheath. The apparatus and method further allow for the use of a swab disposed in a swab holder that is aseptically and removably sealable to a swab cap to protect the swab against decontamination vapors. ## Claims ### Claim 1 A pharmaceutical fill needle system for dispensing pharmaceutical fluids within an aseptic chamber, the fill needle system comprising: a first sterilizable encapsulation portion comprising at least one first mechanical engagement feature and a first sealable surface; a fill needle aseptically sealed to the first encapsulation portion and having a fluid receiving end and a fluid dispensing end, the fluid dispensing end protruding from the first encapsulation portion; a sterilizable fluid path aseptically sealed to the first encapsulation portion, a proximal end of the fluid path being in fluid communication with the fluid receiving end of the fill needle; and a second sterilizable encapsulation portion comprising at least one second mechanical engagement feature and a second sealable surface, the at least one second mechanical engagement feature releasably engaged with the at least one first mechanical engagement feature and the second sealable surface aseptically sealed with the first sealable surface, the first and second encapsulation portions jointly aseptically encapsulating the fill needle. ### Claim 2 (depends on 1) The system of claim 1, further including a removal station having at least one engagement finger wherein the first and second mechanical engagement features are configured for mutual disengagement and re-engagement by interaction with the removal station in the aseptic chamber to uncover and cover the fill needle. ### Claim 3 (depends on 2) The system of claim 2, wherein the second mechanical engagement feature further includes at least two eyelet portions, the eyelet portions defining a void configured to receive the at least one engagement finger of the removal station. ### Claim 4 (depends on 3) The system of claim 3, wherein the second mechanical engagement feature comprises an elastomeric material. ### Claim 5 (depends on 4) The system of claim 4, wherein the elastomeric material is a steam permeable elastomeric material. ### Claim 6 (depends on 1) The system of claim 1, wherein the fill needle assembly is aseptically sealed before use. ### Claim 7 (depends on 1) The system of claim 1, wherein the fill needle assembly is configured for being placed in fluid communication with a fluid source. ### Claim 8 (depends on 7) The system of claim 7, further comprising a fluid path coupled to the fill needle assembly, an exterior of the fluid path being configured to extend into the aseptic chamber through a sealed opening of the aseptic chamber. ### Claim 9 (depends on 8) The system of claim 8 further comprising a fluid container disposed outside of the aseptic chamber, the fluid container being coupled to the fluid path. ### Claim 10 (depends on 9) The system of claim 9 wherein the fluid container further comprises an air filter. ### Claim 11 (depends on 1) The system of claim 1, wherein the fill needle assembly is configured for aseptic cleaning so that the fill needle assembly may be re-usable. ### Claim 12 (depends on 1) The system of claim 1, wherein the first mechanical engagement feature and the second mechanical engagement feature are monolithic such that the mutual mating is achieved by the elasticity of the first and second mechanical engagement features. ### Claim 13 (depends on 1) The system of claim 1, further comprising a tamper-evident feature disposed about at least one of the first and second mechanical engagement features such that the tamper-evident feature indicates a breach of the encapsulation of the fill needle. ### Claim 14 (depends on 1) The system of claim 1, wherein the encapsulation portion is aseptically sealed before use. ### Claim 15 (depends on 1) The system of claim 1, wherein the encapsulation portion is configured for being placed in fluid communication with a fluid source. ### Claim 16 (depends on 15) The system of claim 15, further comprising a fluid path coupled to the encapsulation portion, an exterior of the fluid path being configured to extend into the aseptic environment through a sealed opening of an enclosure of the aseptic environment. ### Claim 17 (depends on 16) The system of claim 16 further comprising a fluid container disposed outside of the aseptic environment, the fluid container being coupled to the fluid path. ### Claim 18 (depends on 17) The system of claim 17 wherein the fluid container further comprises an air filter. ### Claim 19 (depends on 1) The system of claim 1, wherein the encapsulation portion is configured for aseptic cleaning so that the encapsulation portion may be re-usable. ### Claim 20 (depends on 1) The system of claim 1, wherein the first mechanical engagement feature and the second mechanical engagement feature are monolithic such that the mutual mating is achieved by the elasticity of the first and second mechanical engagement features. ### Claim 21 (depends on 1) The system of claim 1, further comprising a tamper-evident feature disposed about at least one of the first and second mechanical engagement features such that the tamper-evident feature indicates a breach of the sealed cavity. ### Claim 22 (depends on 1) The system of claim 1, wherein the encapsulation portion is substantially cylindrical in shape. ### Claim 23 (depends on 1) The system of claim 1, wherein the first mechanical engagement feature portion has a locating ledge, the second mechanical engagement feature has a clamping clip, and the locating ledge engages the clamping clip to mutually mate. ### Claim 24 (depends on 1) The system of claim 1, wherein the encapsulation portion further includes at least two engagement clips configured for engaging with a robotic arm end piece. ### Claim 25 (depends on 1) The system of claim 1, wherein at least one of the first mechanical engagement feature and the second mechanical engagement feature comprise an elastomeric material. ### Claim 26 (depends on 25) The system of claim 25, wherein the elastomeric material is a steam permeable elastomeric material. ### Claim 27 (depends on 1) The system of claim 1, further comprising an o-ring disposed between the first sealable portion and the second sealable portion.