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CGA/GAS - CGA P-8.2

GUIDELINE FOR VALIDATION OF AIR SEPARATION UNIT AND CARGO TRANSPORT UNIT FILLING FOR MEDICAL OXYGEN AND MEDICAL NITROGEN

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Organization: CGA/GAS
Publication Date: 1 January 2018
Status: active
Page Count: 28
scope:

This publication addresses validation for ASU cryogenic manufacturing and cargo transport unit filling processes pertaining to medical oxygen and medical nitrogen.

Document History

CGA P-8.2
January 1, 2018
GUIDELINE FOR VALIDATION OF AIR SEPARATION UNIT AND CARGO TRANSPORT UNIT FILLING FOR MEDICAL OXYGEN AND MEDICAL NITROGEN
This publication addresses validation for ASU cryogenic manufacturing and cargo transport unit filling processes pertaining to medical oxygen and medical nitrogen.
P-8.2
January 1, 2013
GUIDELINE FOR VALIDATION OF AIR SEPARATION UNIT AND CARGO TANK FILLING FOR OXYGEN USP AND NITROGEN NF
This publication addresses validation for ASU cryogenic manufacturing and cargo tank filling processes pertaining to oxygen USP and nitrogen NF.
P-8.2
January 1, 2008
GUIDELINE FOR VALIDATION OF AIR SEPARATION UNIT AND CARGO TANK FILLING FOR OXYGEN USP AND NITROGEN NF
A description is not available for this item.
P-8.2
August 7, 2003
Guideline for Validation of Air Separation Unit and Cargo Tank Filling for Oxygen USP and Nitrogen NF
A description is not available for this item.
P-8.2
January 1, 2001
Air Separation Unit and Trailer Filling Validation Guideline for Oxygen USP and Nitrogen NF
A description is not available for this item.
P-8.2
January 1, 1998
Air Separation Unit and Trailer Filling Validation Guideline for Oxygen USP and Nitrogen NF
A description is not available for this item.
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References

This document references:
TR-3 - THE IMPACT OF AMBIENT AIR CONTAMINANTS ON VALIDATION REQUIREMENTS FOR THE AIR SEPARATION PROCESS
Published by CGA on January 1, 2023
This publication evaluates possible sources of ambient air contamination and the role of the ASU in controlling and eliminating these contaminants. The ASU contaminant evaluation includes: •...
This document references:
CGA P-8.5 - THE IMPACT OF AMBIENT AIR CONTAMINANTS ON VALIDATION REQUIREMENTS FOR THE AIR SEPARATION PROCESS
Published by CGA/GAS on January 1, 2006
A description is not available for this item.
This document references:
21 CFR PART 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
Published by HHS on April 1, 2016
The procedures in this part apply when: (a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner’s...
This document references:
TR-3 - THE IMPACT OF AMBIENT AIR CONTAMINANTS ON VALIDATION REQUIREMENTS FOR THE AIR SEPARATION PROCESS
Published by CGA on January 1, 2023
This publication evaluates possible sources of ambient air contamination and the role of the ASU in controlling and eliminating these contaminants. The ASU contaminant evaluation includes: •...
This document references:
91/356/EEC - Commission Directive Laying down the Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use
Published by EU on January 1, 1991
A description is not available for this item.
This document references:
91/412/EEC - Commission Directive Laying down the Principles and Guidelines of Good Manufacturing Practice for Veterinary Medicinal Products
Published by EU on January 1, 1991
A description is not available for this item.
This document references:
CGA P-8.5 - THE IMPACT OF AMBIENT AIR CONTAMINANTS ON VALIDATION REQUIREMENTS FOR THE AIR SEPARATION PROCESS
Published by CGA/GAS on January 1, 2006
A description is not available for this item.
This document is referenced by:
CGA M-4 - GUIDELINE FOR VALIDATION OF MEDICAL CYLINDER FILLING SYSTEMS
Published by CGA/GAS on January 1, 2019
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...
This document is referenced by:
CGA P-31 - LIQUID OXYGEN, NITROGEN, AND ARGON CRYOGENIC TANKER LOADING SYSTEMS
Published by CGA/GAS on January 1, 2021
This publication describes requirements for new installations designed and constructed after date of publication used for the loading of oxygen, nitrogen, or argon as cryogenic liquids. This...
This document is referenced by:
M-3 - STANDARD FOR THE MANUFACTURER OF BULK MEDICAL GASES
Published by CGA on January 1, 2021
This publication applies to the bulk manufacturing of medical gases as follows: • bulk air separation (oxygen, USP and nitrogen, NF) manufacturing and distribution facilities; • bulk carbon dioxide,...
This document is referenced by:
CGA M-17 - STANDARD FOR AUTOMATIC TRAILER FILL COMPLIANCE TO 21 CFR PART 11 AND PIC/S ANNEX 11 REQUIREMENTS
Published by CGA/GAS on January 1, 2016
A description is not available for this item.
This document is referenced by:
CGA P-8 - GUIDELINE FOR SAFE PRACTICES FOR CRYOGENIC AIR SEPARATION PLANTS
Published by CGA/GAS on January 1, 2020
A description is not available for this item.
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