Publication

M-17: Standard for Automatic Trailer Fill Compliance to 21 CFR Part 11 and PIC/S Annex 11 Requirements

Abstract

This publication applies to ATF systems and records, including trailers, microbulk vessels, railcars, and ISO containers at bulk medical gas and bulk food gas manufacturing facilities.
In addition to the guidance in this publication, see CGA M-27, Guideline for Complying with Data Integrity Regulatory Expectations, for more information on compliance with data integrity requirements for ATF systems [3].

This publication does not cover the filling of compressed gas cylinders or small cryogenic containers.

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Properties

Edition:
2
Published:
February 2022
Status:
Available To the Public
Size:
5 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Gases