Robotic control for aseptic processing

Inventors

SCIALÒ, Giovanni • RECCHIA, Davide • Bechini, Claudio

Assignees

Pharma Integration SRL • Particle Measuring Systems Inc

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Publication Number

US-11892462-B2

Patent

Publication Date

2024-02-06

Expiration Date


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.

Core Innovation

The invention provides an impactor for sampling a fluid flow containing particles using a sampling head having one or more intake apertures and a selectively removable cover for covering the intake apertures. The sampling head and an impactor base engage to enclose an impact surface, while the impactor base is operationally connected to receive at least a portion of the fluid flow and includes an outlet for exhausting the fluid flow.

A first cover magnet is fixed to an underside of the selectively removable cover, and a second cover magnet is spaced apart from the first cover magnet and protrudes from the underside of the selectively removable cover. The sampling head and impactor base are configured so that the cover magnets interact with magnets associated with the engaged sampling head and impactor base to hold and retain the selectively removable cover in place while enclosing the impact surface.

The system is described for automated and robotic aseptic particle sampling and analysis, including robotic manipulation of a component of the impactor. The document further describes optically transparent components for in situ optical detection and imaging, robotic sterilization in a fully assembled enclosed configuration to reduce operator false positives, and growing biological particles received by the impact surface, including later CFU counting and genus and species identification.

Claims Coverage

The document includes two independent claims. The claim coverage centers on an impactor structure using a selectively removable cover held by spaced cover magnets, and on a method for sampling biological particles using the impactor and magnet-based manipulating followed by growing. The inventive features are directed to enclosing the impact surface and integrating magnetic manipulation into a biological particle sampling and culturing workflow.

Magnet-coupled selectively removable cover to enclose the impact surface

An impactor comprising a sampling head with one or more intake apertures and a selectively removable cover; an impactor base operationally connected to receive at least a portion of the fluid flow, the impactor base comprising an impact surface and an outlet; 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, wherein the sampling head and the impactor base engage to enclose the impact surface.

Magnet-based manipulating via a magnetic hand tool before growing biological particles

A method for sampling biological particles from a fluid flow comprising drawing a fluid flow through one or more intake apertures into a sampling head of an impactor containing biological particles, impacting at least some biological particles onto an impact surface of an 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 with 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.

Across the independent claims, the core claim coverage centers on enclosing the impact surface using a selectively removable cover retained by spaced cover magnets and on integrating magnet-based manipulating, including manual manipulation via a magnetic hand tool, into a method that draws, impacts, exhausts, and then grows biological particles received by the impact surface.

Stated Advantages

Reduced operator false positives as biological particles are cultured with an enclosed impact surface.

Enables in situ optical detection and imaging by using optically transparent components.

Documented Applications

Automated and robotic aseptic particle sampling and analysis in cleanroom/RABS or positive pressure isolator contexts, including later CFU counting and genus and species identification as described.

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