Patent · US10067151B2 · B2 · US

Method for protecting and unprotecting the fluid path in a controlled environment enclosure

(11) Publication number

US10067151B2

(21) Application number

15/375,019

(22) Filing date

2016-12-09

(30) Priority date

2015-12-10

(43) Publication date

2018-09-04

(45) Date of grant

2018-09-04

(51) IPC

A61J 1/14; A61J 1/20; B01L 3/02; B65B 3/00; B65B 3/04; B65B 55/12; G01N 35/00; G01N 35/10

(52) CPC

G01N Investigating or analysing materials by determining their chemical or physical properties: 35/10, 2035/00148, 2035/00277, 35/00029, 35/0099
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: 1/12, 1/14, 1/20
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: 2/07, 2/16, 2/24
B01L Chemical or physical laboratory apparatus for general use: 1/025, 1/04, 2200/026, 2200/0689, 2200/141, 2300/0609, 2300/0832, 2400/0487, 3/02
B25J Manipulators; chambers provided with manipulation devices: 21/00
B65B Machines, apparatus or devices for, or methods of, packaging articles or materials; unpacking: 3/003, 3/04, 55/12
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}: 29/00, 37/02, 41/14

(73) Assignee

VanRx Pharmasystems Inc

(72) Inventors

Christopher Procyshyn; Marcin Cichy

(54) Title

Method for protecting and unprotecting the fluid path in a controlled environment enclosure

(57) 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 molded 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.

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Claims (12)

A fluid handling assembly for automatically carrying out a fluid handling process in an aseptic environment, the fluid handling assembly disposed in a controlled environment enclosure configured to aseptically isolate the process and hold the fluid handling assembly, further disposed with a robot arm disposed within the enclosure to manipulate the fluid handling assembly, the fluid handling assembly comprising: an implement portion for conveying fluid in the fluid handling process; a first sheath portion, the implement portion disposed within the first sheath portion, the first sheath portion including: a first locking mechanism portion, and a first sealing portion, a second sheath portion including: a second locking mechanism portion configured to mate with the first locking mechanism portion, and a second sealing portion disposed to aseptically seal with the first sealing portion when the first and second locking mechanism portions are mutually mated, and wherein the first and second sheath portions define a sealed cavity that aseptically encapsulates the implement portion when the first and second locking mechanism portions are mutually mated.
The assembly of claim 1 wherein the assembly is a fill assembly and the implement portion comprises a proximal dispensing portion of a fill needle, the fill needle including a fluid conduit that extends through the first sheath portion to a distal fluid supply end so that, when the first and second locking mechanism portions are mutually mated, the proximal dispensing portion of the fill needle is located inside the cavity and the distal fluid supply end of the fluid conduit is located outside the cavity.
The assembly of claim 2 wherein the fluid conduit includes a flexible tube in fluid communication with the proximal dispensing portion of the fill needle.
The assembly of claim 1 wherein the assembly is a swab assembly and the implement portion comprises a swab disposed inside the cavity when the first and second locking mechanism portions are mutually mated.
The assembly of claim 1 further comprising: an articulated arm associated with the robot arm disposed within the enclosure to manipulate the fluid handling assembly.
The assembly of claim 5 wherein the first and second sheath portions respectively comprise first and second engagement portions.
The assembly of claim 6 further comprising: a robotic arm endpiece for the robotic arm, the endpiece configured to bear the first sheath portion by engagement with positive detent with the first engagement portion; and a holding station comprising a first holding fixture to hold the second sheath portion, the fixture configured for engaging with the second engagement portion.
The assembly of claim 7 wherein the holding fixture comprises angled fingers disposed to engage with the second engagement portion of the second sheath portion to release the first sheath portion from the second sheath portion.
The assembly of claim 8 wherein the holding station comprises a second holding fixture configured to suspend the mutually engaged first and second sheath portions.
The assembly of claim 1 wherein the first and second sheath portions are separate injection molded parts and wherein the locking mechanism portions include at least one integrally molded spring member.
The assembly of claim 10 further including a tamper indicator that is mechanically linked to one of the locking mechanism portions and includes a portion that is constructed to irreversibly tear in response to the mechanical separation of the first and second sealing surfaces.
The assembly of claim 1 wherein: the first and second locking mechanism portions are configured to mutually mate when the first and second locking mechanism portions are moved towards each other along a locking axis, the first sheath portion further includes a first bearing surface positioned at least generally normal to the locking axis, and the second sheath portion further includes a second bearing surface positioned at least generally normal to the locking axis and facing the first bearing surface.

Description

This document relates generally to apparatus and methods for use in handling materials in controlled environment enclosures, including apparatus and methods for aseptically filling pharmaceutical containers using a fluid path that is protected and unprotected.

Controlled environment enclosures are known in the art. Such enclosures are used, for example, for containment of hazardous materials. In other examples controlled environment enclosures are used to provide controlled environments with limited numbers of particulates.

In the art controlled environment enclosures are typically fitted with ports for transfer of materials in and out of the enclosure and the ports are fitted with gloves for manual manipulation of equipment, parts or materials inside the enclosure. Such gloves are subject to significant risk of puncture.

In some examples known in the art the controlled environment enclosure is also used to limit exposure to viable particulates. Such controlled environment enclosures may be required for aseptic processing of cell cultures and for the manufacture of pharmaceutical products, medical devices, food or food ingredients. In these cases it is a requirement that the controlled environment enclosure be decontaminated. This may be done thermally using steam or chemically using chemical agents. Suitable chemical agents known in the art include hydrogen peroxide, ozone, beta-propiolactone, aziridine, formaldehyde, chlorine dioxide, ethylene oxide, propylene oxide, and peracetic acid. In most cases the decontamination and sterilization operations have to be preceded by a cleaning process.

Citations (6)

US4376634A
US4976699A
US5341854A
US6116670A
US8372353B2
WO2009123911A2

Record as JSON

{
  "publication_number": "US10067151B2",
  "country": "US",
  "kind": "B2",
  "title": "Method for protecting and unprotecting the fluid path in a controlled environment enclosure",
  "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 molded 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": [
    "1. A fluid handling assembly for automatically carrying out a fluid handling process in an aseptic environment, the fluid handling assembly disposed in a controlled environment enclosure configured to aseptically isolate the process and hold the fluid handling assembly, further disposed with a robot arm disposed within the enclosure to manipulate the fluid handling assembly, the fluid handling assembly comprising: an implement portion for conveying fluid in the fluid handling process; a first sheath portion, the implement portion disposed within the first sheath portion, the first sheath portion including: a first locking mechanism portion, and a first sealing portion, a second sheath portion including: a second locking mechanism portion configured to mate with the first locking mechanism portion, and a second sealing portion disposed to aseptically seal with the first sealing portion when the first and second locking mechanism portions are mutually mated, and wherein the first and second sheath portions define a sealed cavity that aseptically encapsulates the implement portion when the first and second locking mechanism portions are mutually mated.",
    "2. The assembly of claim 1 wherein the assembly is a fill assembly and the implement portion comprises a proximal dispensing portion of a fill needle, the fill needle including a fluid conduit that extends through the first sheath portion to a distal fluid supply end so that, when the first and second locking mechanism portions are mutually mated, the proximal dispensing portion of the fill needle is located inside the cavity and the distal fluid supply end of the fluid conduit is located outside the cavity.",
    "3. The assembly of claim 2 wherein the fluid conduit includes a flexible tube in fluid communication with the proximal dispensing portion of the fill needle.",
    "4. The assembly of claim 1 wherein the assembly is a swab assembly and the implement portion comprises a swab disposed inside the cavity when the first and second locking mechanism portions are mutually mated.",
    "5. The assembly of claim 1 further comprising: an articulated arm associated with the robot arm disposed within the enclosure to manipulate the fluid handling assembly.",
    "6. The assembly of claim 5 wherein the first and second sheath portions respectively comprise first and second engagement portions.",
    "7. The assembly of claim 6 further comprising: a robotic arm endpiece for the robotic arm, the endpiece configured to bear the first sheath portion by engagement with positive detent with the first engagement portion; and a holding station comprising a first holding fixture to hold the second sheath portion, the fixture configured for engaging with the second engagement portion.",
    "8. The assembly of claim 7 wherein the holding fixture comprises angled fingers disposed to engage with the second engagement portion of the second sheath portion to release the first sheath portion from the second sheath portion.",
    "9. The assembly of claim 8 wherein the holding station comprises a second holding fixture configured to suspend the mutually engaged first and second sheath portions.",
    "10. The assembly of claim 1 wherein the first and second sheath portions are separate injection molded parts and wherein the locking mechanism portions include at least one integrally molded spring member.",
    "11. The assembly of claim 10 further including a tamper indicator that is mechanically linked to one of the locking mechanism portions and includes a portion that is constructed to irreversibly tear in response to the mechanical separation of the first and second sealing surfaces.",
    "12. The assembly of claim 1 wherein: the first and second locking mechanism portions are configured to mutually mate when the first and second locking mechanism portions are moved towards each other along a locking axis, the first sheath portion further includes a first bearing surface positioned at least generally normal to the locking axis, and the second sheath portion further includes a second bearing surface positioned at least generally normal to the locking axis and facing the first bearing surface."
  ],
  "description_excerpt": "This document relates generally to apparatus and methods for use in handling materials in controlled environment enclosures, including apparatus and methods for aseptically filling pharmaceutical containers using a fluid path that is protected and unprotected.\n\nControlled environment enclosures are known in the art. Such enclosures are used, for example, for containment of hazardous materials. In other examples controlled environment enclosures are used to provide controlled environments with limited numbers of particulates.\n\nIn the art controlled environment enclosures are typically fitted with ports for transfer of materials in and out of the enclosure and the ports are fitted with gloves for manual manipulation of equipment, parts or materials inside the enclosure. Such gloves are subject to significant risk of puncture.\n\nIn some examples known in the art the controlled environment enclosure is also used to limit exposure to viable particulates. Such controlled environment enclosures may be required for aseptic processing of cell cultures and for the manufacture of pharmaceutical products, medical devices, food or food ingredients. In these cases it is a requirement that the controlled environment enclosure be decontaminated. This may be done thermally using steam or chemically using chemical agents. Suitable chemical agents known in the art include hydrogen peroxide, ozone, beta-propiolactone, aziridine, formaldehyde, chlorine dioxide, ethylene oxide, propylene oxide, and peracetic acid. In most cases the decontamination and sterilization operations have to be preceded by a cleaning process.",
  "cpc": [
    "G01N 35/10",
    "A61J 1/12",
    "A61J 1/14",
    "A61J 1/20",
    "A61L 2/07",
    "A61L 2/16",
    "A61L 2/24",
    "B01L 1/025",
    "B01L 1/04",
    "B01L 2200/026",
    "B01L 2200/0689",
    "B01L 2200/141",
    "B01L 2300/0609",
    "B01L 2300/0832",
    "B01L 2400/0487",
    "B01L 3/02",
    "B25J 21/00",
    "B65B 3/003",
    "B65B 3/04",
    "B65B 55/12",
    "C12M 29/00",
    "C12M 37/02",
    "C12M 41/14",
    "G01N 2035/00148",
    "G01N 2035/00277",
    "G01N 35/00029",
    "G01N 35/0099"
  ],
  "ipc": [
    "A61J 1/14",
    "A61J 1/20",
    "B01L 3/02",
    "B65B 3/00",
    "B65B 3/04",
    "B65B 55/12",
    "G01N 35/00",
    "G01N 35/10"
  ],
  "assignees": [
    "VanRx Pharmasystems Inc"
  ],
  "inventors": [
    "Christopher Procyshyn",
    "Marcin Cichy"
  ],
  "filing_date": "2016-12-09",
  "publication_date": "2018-09-04",
  "grant_date": "2018-09-04",
  "priority_date": "2015-12-10",
  "application_number": "US-201615375019-A",
  "family_id": "59013756",
  "cited_by_count": 2,
  "citations": [
    "US4376634A",
    "US4976699A",
    "US5341854A",
    "US6116670A",
    "US8372353B2",
    "WO2009123911A2"
  ]
}

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