Publication

M-14.1: Bulk Trailer Change of Grade Validation Protocol

Abstract

The scope of this publication is the qualification of the change of grade (COG) process, which involves the conversion of a nonmedical cryogenic transport trailer to medical-grade. This includes converting trailers from:
– nonmedical oxygen to oxygen, USP; and
– nonmedical nitrogen to nitrogen, NF.

This publication is limited to a COG using the purge methods identified in CGA M-14, where the nonmedical grade product is replaced by a medical grade product.

This publication does not apply to trailers that undergo a change of service from one product to another product such as oxygen to nitrogen, nitrogen to oxygen, etc.

The medical liquid products included within the scope of this validation are oxygen, USP and nitrogen, NF.

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Properties

Edition:
1
Published:
December 2013, reaffirmed December 2019
Status:
Available To the Public
Size:
34 pages
Publisher:
CGA
Special Attributes:
Notes:
Reaffirmed 2019
Committee:
Medical Gases

Cataloging

Category
Medical Gases     Standards & Guidelines
Keywords
bulk medical liquids  |  bulk transport  |  change of grade  |  nitrogen  |  oxygen, liquid  |  Validation  |  Validation Protocol
Related
M-14  |  P-8.2