Publication

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

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.

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Properties

Edition:
6
Published:
November 2018, reaffirmed July 2024
Status:
Available To the Public
Size:
21 pages
Publisher:
CGA
Special Attributes:
Harmonized
Notes:
Reaffirmed 2024
Committee:
Medical Gases

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