Publication Details

[P-8.2] Guideline for Validation of Air Separation Unit and Cargo Transport Unit Filling for Medical Oxygen and Medical Nitrogen

Properties:

Title Guideline for Validation of Air Separation Unit and Cargo Transport Unit Filling for Medical Oxygen and Medical Nitrogen
Edition 6
Published November, 2018
Status Available to the public
Size 21 pages
Publisher CGA
Special Attributes Harmonized
Notes
Committee Medical Gases


Abstract:

This publication provides the Compressed Gas Association (CGA) position and guidance on the manufacturing, bulk product storage, and cargo transport unit filling validation activities that take place at a typical air separation unit that is manufacturing medical oxygen, medical nitrogen, or both. Variations from the typical ASU process configurations can exist. Companies shall assess variations and determine if deviations from this guidance are necessary.

This publication addresses validation for air separation unit cryogenic manufacturing and cargo transport unit filling processes pertaining to medical oxygen and medical nitrogen.


Cataloging:

Category Protection and Safe Handling     Standards & Guidelines
Keywords air  |  air separation plants  |  cargo tanks  |  medical gases  |  nitrogen  |  oxygen  |  Validation
Related M-14  |  M-14.1  |  TR-3

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