Description

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 includehigh 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 suchas operations conducted at air separation plants. For information on bulk operations, see CGA P-8.2, Guidelinefor Validation of Air Separation Unit and Cargo Tank Filling for Oxygen USP and Nitrogen NF [1].

Product Details

Edition:

1st

Published:

05/01/2012

Number of Pages:

50

File Size:

1 file , 780 KB

Note:

This product is unavailable in Russia, Ukraine, Belarus

Description

CGA M-4 – Guideline for Validation of Medical Cylinder Filling Systems

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.

Product Details

Edition:

2nd

Published:

05/17/2019

Number of Pages:

43

File Size:

1 file , 1.5 MB

Note:

This product is unavailable in Russia, Ukraine, Belarus