Patent · US11892462B2 · B2 · US

Robotic control for aseptic processing

(11) Publication number

US11892462B2

(21) Application number

17/151,899

(22) Filing date

2021-01-19

(30) Priority date

2020-01-21

(43) Publication date

2024-02-06

(45) Date of grant

2024-02-06

(51) IPC

B01L 3/00; B25J 11/00; B25J 9/00; C12M 1/00; C12M 1/12; C12Q 1/04; G01N 1/22; G01N 35/00

(52) CPC

G01N Investigating or analysing materials by determining their chemical or physical properties: 35/0099, 1/2208, 1/2273, 15/01, 15/0227, 15/0612, 15/1433, 2015/0294, 2015/1006, 2015/1493, 2015/1497
B01L Chemical or physical laboratory apparatus for general use: 2200/0689, 2300/04, 2300/168, 3/502
B25J Manipulators; chambers provided with manipulation devices: 11/00, 9/0009
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}: 23/22, 37/00, 41/36
C12Q Measuring or testing processes involving enzymes, nucleic acids or microorganisms; compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes: 1/04

(73) Assignee

PARTICLE MEASURING SYST; PHARMA INTEGRATION SRL

(72) Inventors

SCIALÒ GIOVANNI; RECCHIA DAVIDE; BECHINI CLAUDIO

(54) Title

Robotic control for aseptic processing

(57) Abstract

Devices and methods for sampling, detecting and/or characterizing particles, for example, via collection, growth and analysis of viable biological particles such as microorganisms. Devices and methods of the invention include particle samplers and impactors including a sampling head comprising one or more intake apertures, a selectively removable cover, an impactor base connected to the sampling head, and one or more magnets fixed to the sampling head, the selectively removable cover and/or the impactor base. The one or more magnets allow for robotic manipulation of the impactor devices.

Full text

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Claims (23)

An impactor comprising: a sampling head comprising one or more intake apertures for sampling a fluid flow containing particles and a selectively removable cover for covering the one or more intake apertures; and an impactor base operationally connected to receive at least a portion of the fluid flow from the sampling head; the impactor base comprising an impact surface for receiving at least a portion of the particles in the fluid flow and an outlet for exhausting the fluid flow; a first cover magnet fixed to an underside of the selectively removable cover; and a second cover magnet spaced apart from the first cover magnet and protruding from the underside of the selectively removable cover; wherein the sampling head and the impactor base engage to enclose the impact surface.
The impactor of claim 1, the impactor comprising: a sampling head magnet fixed to the sampling head, the sampling head magnet configured to mate with the second cover magnet.
The impactor of claim 2, wherein the one or more intake apertures are disposed in a radial array on the sampling head, and wherein the sampling head magnet is fixed to the sampling head in the center of the radial array.
The impactor of claim 1, wherein an impactor base magnet is fixed to the impactor base.
The impactor of claim 1, further comprising a sampling head magnet fixed to the sampling head, the impactor comprising: an impactor base magnet fixed to the impactor base.
The impactor of claim 1 wherein the sampling head and selectively removable cover engage via a compressible sealing member.
The impactor of claim 6, wherein the impactor is configured to compress the compressible sealing member via magnetic attraction between the sampling head magnet and the cover magnet.
The impactor of claim 7, wherein the compressible sealing member is an O-ring.
The impactor of claim 1, wherein the an impactor base magnet is fixed to a receiving surface of the impactor via an adhesive.
The impactor of claim 1, wherein an impactor base magnet is cast into the sampling head or the impactor base.
The impactor of claim 1, wherein an impactor base magnet is at least partially enclosed by a magnet chamber of the impactor.
The impactor of claim 1, wherein the impactor is configured for robotic manipulation via a robotic device.
The impactor of claim 1, wherein the first cover magnet is configured to engage with a robotic device magnet of a robotic device.
The impactor of claim 1, wherein the impactor is configured for robotic removal of the selectively removable cover from the sampling head via a robotic device to expose the one or more intake apertures to an ambient environment.
The impactor of claim 1, wherein the impactor is configured for robotic replacement of a selectively removable cover onto the sampling head via a robotic device to seal the impact surface off from to an ambient environment.
The impactor of claim 1, wherein the impactor is configured for robotic sterilization of an outer surface of the impactor.
The impactor of claim 1, wherein the particles are microorganisms.
The impactor of claim 1, wherein the impactor base further comprises a growth medium positioned to receive the particles in the fluid flow, wherein the impact surface is a receiving surface of the growth medium.
The impactor of claim 18, wherein the impactor base, sampling head or both are optically transparent so as to allow visualization, optical detection or imaging of particles in the growth medium without physically accessing the growth medium.
The impactor of claim 1, wherein the impactor is configured to be sterilized in a fully assembled configuration wherein the impact surface remains enclosed by the sampling head and impactor base.
A method for sampling biological particles from a fluid flow, the method comprising: drawing a fluid flow through one or more intake apertures and into a sampling head of an impactor, wherein the fluid flow contains biological particles; impacting at least some of the biological particles onto an impact surface of an impactor base, the impactor base engaging the sampling head to enclose the impact surface; exhausting the fluid flow from the sampling head; manipulating the impactor or a component thereof via a magnet fixed to the impactor, wherein the manipulating comprises manual manipulation of the impactor or a component thereof via a magnetic hand tool; and growing at least a portion of the biological particles received by the impact surface.
The method of claim 21, wherein the manipulating step occurs prior to the drawing a fluid step.
The method of claim 21, wherein the manipulation step occurs after the growing step.

Description

This invention is in the field of particle sampling, collection and analysis. This invention relates generally to systems and methods for robotic sampling and counting systems for sampling particles from fluids in controlled environments. Cleanrooms and clean zones are commonly used in semiconductor and pharmaceutical manufacturing facilities. For the semiconductor industry, an increase in airborne particulate concentration can result in a decrease in fabrication efficiency, as particles that settle on semiconductor wafers will impact or interfere with the small length scale manufacturing processes. For the pharmaceutical industry, where this type of real-time efficiency feedback is lacking, contamination by airborne particulates and biological contaminants puts pharmaceutical products at risk for failing to meet cleanliness level standards established by the U.S. Food and Drug Administration (FDA) and other foreign and international health regulatory agencies. Humans being present in such environments increases the risk of particulate and biological contamination levels. Increasingly, controlled environment systems are moving towards automated or robotic systems in order to limit or eliminate human interaction. However, many applications requiring controlled environments also require or utilize environmental sampling to ensure that viable and non-viable particles and/or organisms remain below the desired levels.

Standards for the classification of cleanroom particle levels and standards for testing and monitoring to ensure compliance are provided by ISO 14664-1 and 14664-2.

Citations (183)

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Record as JSON

{
  "publication_number": "US11892462B2",
  "country": "US",
  "kind": "B2",
  "title": "Robotic control for aseptic processing",
  "abstract": "Devices and methods for sampling, detecting and/or characterizing particles, for example, via collection, growth and analysis of viable biological particles such as microorganisms. Devices and methods of the invention include particle samplers and impactors including a sampling head comprising one or more intake apertures, a selectively removable cover, an impactor base connected to the sampling head, and one or more magnets fixed to the sampling head, the selectively removable cover and/or the impactor base. The one or more magnets allow for robotic manipulation of the impactor devices.",
  "claims": [
    "1. An impactor comprising: a sampling head comprising one or more intake apertures for sampling a fluid flow containing particles and a selectively removable cover for covering the one or more intake apertures; and an impactor base operationally connected to receive at least a portion of the fluid flow from the sampling head; the impactor base comprising an impact surface for receiving at least a portion of the particles in the fluid flow and an outlet for exhausting the fluid flow; a first cover magnet fixed to an underside of the selectively removable cover; and a second cover magnet spaced apart from the first cover magnet and protruding from the underside of the selectively removable cover; wherein the sampling head and the impactor base engage to enclose the impact surface.",
    "2. The impactor of claim 1, the impactor comprising: a sampling head magnet fixed to the sampling head, the sampling head magnet configured to mate with the second cover magnet.",
    "3. The impactor of claim 2, wherein the one or more intake apertures are disposed in a radial array on the sampling head, and wherein the sampling head magnet is fixed to the sampling head in the center of the radial array.",
    "4. The impactor of claim 1, wherein an impactor base magnet is fixed to the impactor base.",
    "5. The impactor of claim 1, further comprising a sampling head magnet fixed to the sampling head, the impactor comprising: an impactor base magnet fixed to the impactor base.",
    "6. The impactor of claim 1 wherein the sampling head and selectively removable cover engage via a compressible sealing member.",
    "7. The impactor of claim 6, wherein the impactor is configured to compress the compressible sealing member via magnetic attraction between the sampling head magnet and the cover magnet.",
    "8. The impactor of claim 7, wherein the compressible sealing member is an O-ring.",
    "9. The impactor of claim 1, wherein the an impactor base magnet is fixed to a receiving surface of the impactor via an adhesive.",
    "10. The impactor of claim 1, wherein an impactor base magnet is cast into the sampling head or the impactor base.",
    "11. The impactor of claim 1, wherein an impactor base magnet is at least partially enclosed by a magnet chamber of the impactor.",
    "12. The impactor of claim 1, wherein the impactor is configured for robotic manipulation via a robotic device.",
    "13. The impactor of claim 1, wherein the first cover magnet is configured to engage with a robotic device magnet of a robotic device.",
    "14. The impactor of claim 1, wherein the impactor is configured for robotic removal of the selectively removable cover from the sampling head via a robotic device to expose the one or more intake apertures to an ambient environment.",
    "15. The impactor of claim 1, wherein the impactor is configured for robotic replacement of a selectively removable cover onto the sampling head via a robotic device to seal the impact surface off from to an ambient environment.",
    "16. The impactor of claim 1, wherein the impactor is configured for robotic sterilization of an outer surface of the impactor.",
    "17. The impactor of claim 1, wherein the particles are microorganisms.",
    "18. The impactor of claim 1, wherein the impactor base further comprises a growth medium positioned to receive the particles in the fluid flow, wherein the impact surface is a receiving surface of the growth medium.",
    "19. The impactor of claim 18, wherein the impactor base, sampling head or both are optically transparent so as to allow visualization, optical detection or imaging of particles in the growth medium without physically accessing the growth medium.",
    "20. The impactor of claim 1, wherein the impactor is configured to be sterilized in a fully assembled configuration wherein the impact surface remains enclosed by the sampling head and impactor base.",
    "21. A method for sampling biological particles from a fluid flow, the method comprising: drawing a fluid flow through one or more intake apertures and into a sampling head of an impactor, wherein the fluid flow contains biological particles; impacting at least some of the biological particles onto an impact surface of an impactor base, the impactor base engaging the sampling head to enclose the impact surface; exhausting the fluid flow from the sampling head; manipulating the impactor or a component thereof via a magnet fixed to the impactor, wherein the manipulating comprises manual manipulation of the impactor or a component thereof via a magnetic hand tool; and growing at least a portion of the biological particles received by the impact surface.",
    "22. The method of claim 21, wherein the manipulating step occurs prior to the drawing a fluid step.",
    "23. The method of claim 21, wherein the manipulation step occurs after the growing step."
  ],
  "description_excerpt": "This invention is in the field of particle sampling, collection and analysis. This invention relates generally to systems and methods for robotic sampling and counting systems for sampling particles from fluids in controlled environments. Cleanrooms and clean zones are commonly used in semiconductor and pharmaceutical manufacturing facilities. For the semiconductor industry, an increase in airborne particulate concentration can result in a decrease in fabrication efficiency, as particles that settle on semiconductor wafers will impact or interfere with the small length scale manufacturing processes. For the pharmaceutical industry, where this type of real-time efficiency feedback is lacking, contamination by airborne particulates and biological contaminants puts pharmaceutical products at risk for failing to meet cleanliness level standards established by the U.S. Food and Drug Administration (FDA) and other foreign and international health regulatory agencies. Humans being present in such environments increases the risk of particulate and biological contamination levels. Increasingly, controlled environment systems are moving towards automated or robotic systems in order to limit or eliminate human interaction. However, many applications requiring controlled environments also require or utilize environmental sampling to ensure that viable and non-viable particles and/or organisms remain below the desired levels.\n\nStandards for the classification of cleanroom particle levels and standards for testing and monitoring to ensure compliance are provided by ISO 14664-1 and 14664-2.",
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    "G01N 35/00"
  ],
  "assignees": [
    "PARTICLE MEASURING SYST",
    "PHARMA INTEGRATION SRL"
  ],
  "inventors": [
    "SCIALÒ GIOVANNI",
    "RECCHIA DAVIDE",
    "BECHINI CLAUDIO"
  ],
  "filing_date": "2021-01-19",
  "publication_date": "2024-02-06",
  "grant_date": "2024-02-06",
  "priority_date": "2020-01-21",
  "application_number": "US-202117151899-A",
  "family_id": "76857621",
  "citations": [
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