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

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  • Description
  • Table of Contents

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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Table of Contents:

    Introduction
    Scope
    Normative References
    Terms and Definitions
    Acronyms /Abbreviations
    Large-Virus Retentive Filter Test Protocols
    Strategy
    Model virus
    Model proteins
    Model protein acceptance criteria
    Buffer system
    Scaled-down model filters
    Operating parameters
    Hold and System Control
    Nomenclature acceptance criteria
    Other considerations
    Other acceptance criteria
    Small-Virus Retentive Filter — Test Protocol
    Strategy
    Model viruses
    Model protein
    Scaled-down model filters
    Operating parameters
    Nomenclature acceptance criteria
    Other considerations
    Other acceptance criteria
    Bacteriophage Preparation Procedures
    Introduction
    Equipment and supplies
    Procedure
    Plate method
    Broth method
    Crude preparation
    Pure concentrate
    Storage
    Procedure for Enumeration of Bacteriophage
    Introduction
    Equipment and supplies
    Procedure
    Preparation of bacteriophage host
    Preparation of dilution tubes and soft agar for use in phage assays
    Phage assays
    Bibliography/ References

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