scope:

This publication provides validation guidance for CMG manufacturing operation at container filling facilities, typically referred to as cylinder filling or packaged gas operations. These container filling operations include high pressure cylinder filling operations, portable cryogenic container filling operations, and small bulk container (for example, vehicle mounted vessel) filling operations.

This publication does not address validation of bulk manufacturing and trailer or railcar filling operations such as operations conducted at air separation plants. For information on bulk operations, see CGA P-8.2, Guideline for Validation of Air Separation Unit and Cargo Tank Filling for Oxygen USP and Nitrogen NF [1].¹

¹ References are shown by bracketed numbers and are listed in order of appearance in the reference section.