Cassette for sterility testing

Inventors

Aviles, Robert C. • Michaud, Devin T. • Browne, Douglas J.

Assignees

Rapid Micro Biosystems Inc

Abstract

The invention provides a device for growing cells—referred to as a cassette. The cell culturing device includes a housing that contains a lid having an optically clear window; a fluid distribution channel; a sample injection port fluidically connected to the fluid distribution channel; a base housing a porous media pad; and a media injection port fluidically connected to the media pad. The lid mates to the base to form a sterile seal; the fluid distribution channel is disposed over the media pad, which is viewable through the optical window; and sample fluid introduced into the fluid distribution channel is distributed evenly to the media pad, e.g., via a plurality of channels. The invention also provides kits that include cassettes of the invention and a tube set.

Core Innovation

The disclosed invention is a cell culturing device that includes a housing having a lid with an optically clear window and a base that comprises a porous media pad. The lid mates to the base to form a sterile seal, and the porous media pad is viewable through the optical window. The housing further includes a fluid distribution channel disposed over the media pad.

The housing includes a sample injection port fluidically connected to the fluid distribution channel, and a media injection port fluidically connected to the media pad. The fluid distribution channel includes a sloped surface that circumferentially surrounds the media pad and slopes from the sample injection port towards the media pad. The fluid distribution channel comprises a plurality of channels that each extend partially around a circumference of the housing.

In additional device refinements described in the provided material, a membrane is used with the media pad to retain cells and to enable viewing of retained cells through the optical window. A pressurizable volume can be provided between the lid and membrane. The disclosed device can further include oxygen scavenger/oxygen indicator features for anaerobic testing, and may include drainage and vent/pressure relief features, with supports for automated stacking/alignment for imaging systems.

The provided material also describes closed cassette system elements for maintaining sterility while delivering sample and nutrient media, including sterile tube sets/kits with needle/shielded connectors and septa or snap-fit keyed orientations, enabling sample/media delivery and waste removal while maintaining sterility. Example results described in the provided material include micrograph-based fluorescence imaging showing growth corresponding to colonies over time.

Claims Coverage

The provided claims include one independent claim covering a cell culturing device with a sterile-sealed optically clear windowed lid, a fluid distribution channel over a porous media pad, and separate fluidic connections for sample injection and media injection, with the media pad viewable through the optical window. The independent claim’s main inventive features are merged below.

Overall, the independent claim is directed to a sterile-sealed cell culturing device that couples an optically clear window for viewing with a porous media pad, and uses a sloped, circumferential fluid distribution channel with multiple partially circumferential channels to deliver fluid from a sample injection port, while a separate media injection port supplies the porous media pad.

Stated Advantages

Documented Applications