CGA P-8.2-2008
美国药典氧气及氦气的空分装置和液货舱的验证指南

Guideline for validation of air separation unit and cargo tank filling for oxygen usp and nitrogen NF

标准号

CGA P-8.2-2008

发布日期

2008年

实施日期

废止日期

无

中国标准分类号

C46

发布单位

US-CGA

引用标准

United States Pharmacopeia and National Formulary, United States Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852. www.usp.org Stokes,, Teri, et.al., Good Computer Validation Practices, "Common Sense Interpretation," Interpharm/CRE Press, 1994. ww

被代替标准

CGA P-8.2-2003

适用范围

This publication addresses validation for ASU cryogenic manufacturing and cargo tank filling processes pertain- ing to oxygen USP and nitrogen NF.