ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters (single user digital version)

ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters addresses the use of virus-removal filters that retain viruses by a size-exclusion mechanism. This document should be considered as a guide intended to provide filter suppliers with an approach to standardizing methodology and nomenclature for large- and small-virus retentive filters using bacteriophage as a model. The objective is to assist users/manufacturers in selecting the most appropriate filter for their specific application needs.

This new American National Standard (ANS) is intended to:

• Provide detailed methods and acceptance criteria for testing bacteriophage (also referred to as phage) retention by large- and small-virus retentive filters,
• Provide methods for preparing and enumerating suitable sized bacteriophage (PP7 and PR772 as models for small and large viruses, respectively) as test items, and
• Guide selection of appropriately rated filters as defined by suppliers in a standardized manner using a risk-based approach.

This is not a substitute for process validation for viral clearance claims.

This Standard is intended to expand on the requirements already defined under FDA regulations and should be viewed only as recommendations.

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Format: PDF (1 file 624 KB)

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