Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) R17: Securing and removing large bioreactor bags

What does R17 require?

There must be mechanisms that hold large single-use bioreactor bags securely while they are in use and let them be removed easily for decontamination once they have been used for GMO dealings.

Maintained by Gerard Blokdyk

Other controls in Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

R1 Enclosable and securable work area
R10 Risk assessment for other reticulated services
R11 Backflow measures where the assessment calls for them
R12 Documenting the backflow assessment
R13 Spill procedures and means for the work area
R14 Closed systems for large scale cultures
R15 Closed systems designed to prevent release
R16 Single-use components testable for leaks

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) controls