Guidelines for Selecting Normal Flow Filters - Pharmaceutical Technology

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Guidelines for Selecting Normal Flow Filters
Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.


Pharmaceutical Technology


Summary

The selection of the optimal normal flow filter is highly process dependent because of the varied performance requirements demanded by each process step. When considering the three main applications of normal flow filters, one should consider filters with the following characteristics:

  • Media sterilization: Filters incorporating high capacity/high flow membrane formats minimize filtration system sizes while meeting full validation and integrity test requirements.
  • Buffer filtration: Sterilizing-grade and bioburden reduction filters providing high permeability and wide chemical compatibility.
  • Product stream filtration: Bioburden reduction filters reduce or eliminate bioburden and particulates immediately before chromatography columns and UF/DF operations. Sterilizing-grade filters provide the highest level of assurance before product hold steps and during bulk drug substance formulation and final vial filling. The quick guide to selection of normal flow filters (inset) provides additional details.

Regardless of the application, proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

Acknowledgments

The authors would like to thank our colleagues Jozsef Vasi, Daniel Calnan, Helena Skoglar, Alisa Liten, Olivier Boizet, and Kristian Nilsson for their valuable contributions to this work.

Jonathan Royce is a senior application scientist and Jeffrey Carter, PhD, is director of filtration R&D, both at GE Healthcare, 14 Walkup Drive, Westborough, MA,
Jakob Liderfelt is a scientist at GE Healthcare, Björkgatan 30, 751 84 Uppsala, Sweden.

References

1. US Department of Health and Human Services, Food and Drug Administration, Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice U.S. Department of Health and Human Services, Food and Drug Administration, September 2004.

2. ASTM Standard F838 - 05, "Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration," ASTM International, West Conshohocken, PA, http://www.astm.org/.

*Bioburden reduction filters are not defined by an industry standard. The term "bioburden reduction" is a designation used to describe a class of filters which provide a high level of microorganism retention (i.e., LRV4-6), but do not yield a sterile effluent under the high bacterial load called for in the ASTM F838-05 test method. Manufacturer claims on bioburden reduction filters vary from "typical" retention data to full validation of a minimum LRV. In practice, most bioburden reduction filters are of a 0.45 or 0.2 urn rating and may yield a sterile fluid in common usage, where bacterial loads are much lower than those used in the ASTM challenge. Nevertheless, process-specific claims of fluid sterilization through the use of a bioburden reduction filter are generally not appropriate.


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