Sterilization Validation of Gas Plasma Exposure Based on ISO Documents(Mainly ISO TC 198 And 194 Documents)
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چکیده
منابع مشابه
Sterilization Validation of Gas Plasma Exposure Based on ISO Documents (Mainly ISO TC 198 And 194 Documents)
There are so many ISO documents to understand and utilize for validation studies and routine control. A biological indicator (BI) is essential for conducting sterilization validation and routine control. ISO 11138-1 and ISO 14161 are the major documents to follow for BI manufacturers and BI users, respectively. In ISO 11138-1, BI manufacturers must utilize a BI with 106 CFU/carrier as an initia...
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ژورنال
عنوان ژورنال: Pharmaceutical Regulatory Affairs: Open Access
سال: 2015
ISSN: 2167-7689
DOI: 10.4172/2167-7689.1000137