CGA M-4:2019

CGA M-4:2019

Guideline for Validation of Medical Cylinder Filling Systems

159,00 €


CGA M-4 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.

Zusätzliche Information

Autor Compressed Gas Association (CGA)
Veröffentlicht von CGA
Document type Normen
Thema /subgroups/31624
Ausgabe 2
Seitenzahl 43
Ersetzt CGA M-4
Schlagwort CGA M-4