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) R15: Closed systems designed to prevent release

What does R15 require?

Closed systems, whether made of reusable or single-use parts, must be designed so that GMOs cannot be released into the facility. The guideline notes this includes release through any ventilation of the closed system, and suggests that a filter with a pore size of 0.2 µm or less is generally suitable for containing aerosols in ventilation lines when fermenting bacteria or cell cultures.

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)

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