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CGA P-8.2-2008

Guideline for Validation of Air Separation Unit and Cargo Tank Filling for Oxygen USP and Nitrogen NF

This guideline provides current industry practice for the validation of an air separation plant manufacturing bulk medical oxygen and nitrogen. Included in the guideline are a Failure Modes and Effects analysis and an HACCP for a typical air separation plant. In addition, the document describes the requirements for validating the load out system, and computer system validations.

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Compressed Gas Association, Inc. [cga]

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