Publication Details

[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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