Publication Details

[M-4] Guideline for Validation of Medical Cylinder Filling Systems


This publication provides validation guidance for compressed medical gas 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 Transport Unit Filling for Medical Oxygen and Medical Nitrogen. This publication does not address analytical method validations, see CGA M-6, Guideline for Analytical Method Validation, for information on analytical method validations for cylinder filling operations.


Category Medical Gases     Standards & Guidelines
Keywords CGMP  |  CGMP compliance  |  cylinder filling  |  cylinders  |  GMP  |  medical gases
Related M-6  |  P-8.2