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CN-114981636-B - Robot control for aseptic processing

CN114981636BCN 114981636 BCN114981636 BCN 114981636BCN-114981636-B

Abstract

Devices and methods for sampling, detecting, and/or characterizing particles, for example, via collection, growth, and analysis of surviving biological particles (such as microorganisms). The apparatus and method of the present invention include a particle sampler and an impact sampler, the impact sampler including a sampling head, a selectively removable cover, an impact sampler base coupled to the sampling head, and one or more magnets, the sampling head including one or more access apertures, the one or more magnets being secured to the sampling head, the selectively removable cover, and/or the impact sampler base. One or more magnets allow robotic manipulation of the impact sampler device.

Inventors

  • G. Sialo
  • D Lei Jiya
  • C. Beckini

Assignees

  • 粒子监测系统有限公司
  • 制药集成有限责任公司

Dates

Publication Date
20260508
Application Date
20210119
Priority Date
20200121

Claims (20)

  1. 1. An impact sampler, comprising: a sampling head comprising one or more access holes for sampling a fluid stream containing particles and a selectively removable cover for covering the one or more access holes, and An impact sampler base operatively connected to receive at least a portion of the fluid flow from the sampling head, the impact sampler base including an impact surface for receiving at least a portion of the particles in the fluid flow and an outlet for discharging the fluid flow; A magnet secured to the sampling head or the impact sampler base, the magnet comprising a first cover magnet secured 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 impact sampler base engage to close the impact surface.
  2. 2. The impact sampler of claim 1, the magnet comprising: A sampling head magnet secured to the sampling head, the sampling head magnet configured to mate with the second cover magnet.
  3. 3. The impact sampler of claim 2, wherein the one or more access holes are arranged in a radial array on the sampling head, and wherein the sampling head magnet is fixed to the sampling head at the center of the radial array.
  4. 4. The impact sampler of claim 1, wherein the magnet comprises: an impact sampler base magnet secured to the impact sampler base.
  5. 5. The impact sampler of claim 1, wherein the magnet comprises: A sampling head magnet secured to the sampling head, and An impact sampler base magnet secured to the impact sampler base.
  6. 6. The impact sampler of claim 2 wherein the sampling head and the selectively removable cover are engaged via a compressible sealing member.
  7. 7. The impact sampler of claim 6, wherein the impact sampler is configured to compress the compressible sealing member via magnetic attraction between the sampling head magnet and the second cover magnet.
  8. 8. The impact sampler of claim 7, wherein the compressible sealing member is an O-ring.
  9. 9. The impact sampler of any one of claims 1-8, wherein the magnet is secured to a receiving surface of the impact sampler via an adhesive.
  10. 10. The impact sampler of any one of claims 1-8 wherein the magnet is cast into the sampling head or the impact sampler base.
  11. 11. The impact sampler of any one of claims 1-8 wherein the magnet is at least partially enclosed by a magnet chamber of the impact sampler.
  12. 12. The impact sampler of any one of claims 1-8, wherein the impact sampler is configured to be robotically maneuvered via robotic means.
  13. 13. The impact sampler of any of claims 1-8, wherein the magnet is configured to engage with a robotic device magnet of a robotic device.
  14. 14. The impact sampler of any one of claims 1-8, wherein the impact sampler is configured to robotically remove the selectively removable cover from the sampling head via robotic means to expose the one or more access apertures to the ambient environment.
  15. 15. The impact sampler of any one of claims 1-8, wherein the impact sampler is configured to robotically replace the selectively removable cover onto the sampling head via robotic means to seal the impact surface from the surrounding environment.
  16. 16. The impact sampler of any one of claims 1-8, wherein the impact sampler is configured to robotically sterilize an outer surface of the impact sampler.
  17. 17. The impact sampler of any one of claims 1-8, wherein the particles are microorganisms.
  18. 18. The impact sampler of any one of claims 1-8 wherein the impact sampler bottom 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. 19. The impact sampler of claim 18 wherein the impact sampler base, the sampling head, or both are optically transparent to allow visualization, optical detection, or imaging of particles in the growth medium without physical contact with the growth medium.
  20. 20. The impact sampler of any one of claims 1-8 wherein the impact sampler is configured to sterilize in a fully assembled configuration wherein the impact surface remains enclosed by the sampling head and the impact sampler base.

Description

Robot control for aseptic processing Cross Reference to Related Applications The present application claims the benefit and priority of U.S. provisional patent application No. 62/963,895, filed 1/21/2020, the entire contents of which are incorporated herein by reference. Background The present invention is in the field of particle sampling, collection and analysis. The present invention relates generally to systems and methods for robotic sampling and counting systems for sampling particles from a fluid in a controlled environment. Clean rooms and clean rooms are commonly used in semiconductor manufacturing facilities and pharmaceutical manufacturing facilities. For the semiconductor industry, an increase in the concentration of particulate matter in the air can result in a decrease in manufacturing efficiency because particles deposited on semiconductor wafers can affect or interfere with small length scale manufacturing processes. For the pharmaceutical industry, where this type of real-time efficiency feedback is lacking, contamination of particulate matter and biological contaminants in the air exposes the pharmaceutical product to risks of not meeting the cleanliness level standards established by the U.S. Food and Drug Administration (FDA) as well as other foreign and international health authorities. Humans present in such environments increase the risk of particulate contamination and biological contamination levels. More and more controlled environment systems are evolving towards automation systems or robotic systems in order to limit or eliminate human interaction. However, many applications requiring a controlled environment also require or utilize environmental sampling to ensure that surviving and non-surviving particles and/or organisms remain below a desired level. ISO 14664-1 and 14664-2 provide standards for classification of clean room particle levels and for testing and monitoring to ensure compliance. Aerosol optical particle counters are commonly used to determine particle contamination levels in clean room and clean room air, while liquid particle counters are used to optically measure particle contamination levels in process fluids. Where microbial particles are of particular concern, such as in the pharmaceutical industry, not only quantifying the number of particles in the air, but also characterizing the viability and characteristics of the microbial particles is a problem. ISO 14698-1 and 14698-2 provide standards for assessing biological contaminants in clean room and clean room environments. Currently, collection and analysis of biological particles in air is typically accomplished using a variety of techniques, including sedimentation plates, touch plates, surface swabs, fingertip sampling, and active air samplers based on impact samplers. Traditionally, cascade impact samplers have been used to collect particles and determine particle size. In these devices, a series of accelerations and inertial impactions continuously strip smaller and smaller particles from the fluid stream. The principle of operation of each stage of the inertial impactor sampler is that particles suspended in the air can be collected by forcing a large change in the direction of the air stream containing the particles, wherein the inertia of the particles will separate the particles from the air stream lines and cause the particles to impact the surface. Biswas et al describe the efficiency of particle collection in a high velocity inertial impactor (environ. Sci. Technology, 1984, 18 (8), 611-616). As the quality standards and government regulatory requirements increase, so too does the demand for lower viable and non-viable particle concentrations, there is a need for improved sampling techniques to reduce false positives and reduce the risk of external contamination by human interaction in a controlled environment. From the foregoing, it can be seen that there remains a need in the art for a particle collection, analysis, and characterization system for sampling and collecting particles and/or organisms from a controlled environment with reduced human interaction so as to reduce the risk of further contamination. These systems may include collection of any analysis of particles within the components of the robot's limited access barrier system or other automated controlled environment process. Disclosure of Invention Systems and methods are provided herein that allow for automated sampling and/or analysis of a controlled environment, for example, to determine the presence, quantity, size, concentration, viability, species, or characteristics of particles in the environment. The described systems and methods may utilize robotics or automation, or may eliminate some or all of the collection or analysis steps that are traditionally performed by a human operator. The methods and systems described herein are versatile and may be used with known particle sampling and analysis techniques and devices, includi