Pharma Focus Europe

Integrity testing of Planova™ BioEX virus removal filters used in the manufacture of biological products

Shinya Sekinea, Masayasu Komurob, Takayuki Sohkac, Terry Satoc

Abstract

Ensuring the integrity of virus filters is crucial for the safety of biological products. There are two main types of defects that can affect virus filter performance: improper pore-size distribution and specific damage like tears, broken fibers, or pinholes. Asahi Kasei Medical conducts two integrity tests on each filter to guarantee defect-free products before shipping. Our study confirmed that the typical use of Planova™ BioEX filters does not alter the pore-size distribution inappropriately. For end-users, air-water diffusion-based leakage tests can sensitively detect damage occurring during shipment or use, such as broken fibers or pinholes. To establish standard acceptance criteria for the leakage test, we tested filters with model pinhole defects of various sizes, correlating them with logarithmic reduction values (LRVs) of porcine parvovirus infectivity. Our findings indicate that pinhole defects below a certain size, relative to the effective filter surface area, do not significantly impact virus LRV. In conclusion, the leakage test is sensitive enough to serve as the sole end-user integrity test for Planova™ BioEX filters, facilitating their use in biopharmaceutical manufacturing.

Author Affiliations:  Bioprocess Technology Development Department, Asahi Kasei Medical MT Corporation, 5-4960 Nakagawara, Nobeoka, Miyazaki 882-0031, Japan

Medical Material Laboratory, Medical Products Development Division, Asahi Kasei Medical Co., Ltd., 5-4960 Nakagawara, Nobeoka, Miyazaki 882-0031, Japan

Technical Marketing Department, Bioprocess Division, Asahi Kasei Medical Co., Ltd., 1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan

Citation: Shinya Sekinea, Masayasu Komurob, Takayuki Sohkac, Terry Satoc Integrity testing of Planova™ BioEX virus removal filters used in the manufacture of biological products 2015 doi : http://dx.doi.org/10.1016/j.biologicals.2015.02.003

Received 25 August 2014, Revised 7 February 2015, Accepted 9 February 2015, Available online 7 March 2015

Keywords

Planova™ BioEX virus filter; Air/water diffusion-based leakage test; Integrity testing; Forward/diffusive flow; Biologicals

Abbreviations

BP, bubble point; GPT, gold particle test;IT, integrity test; LRV, logarithmic reduction value; Lv, leak value; PLT, Planova™ Leak Tester; PPV, porcine parvovirus; PVDF, polyvinylidene fluoride; SD, standard deviation; TCID50, 50% tissue culture infectious dose

Acknowledgments

The authors thank L.P.S. Works Co., Ltd. for their laser processing of pinhole fibers. The authors thank Dr. Marcus Inouye, Dr. Masayasu Takahara, Mr. Tomo Miyabayashi, and Mr. Fujiharu Nagoya for their valuable suggestions, Mr. Nobufumi Kawano, Mr. Kazuya Kobayashi, and Dr. Kouichirou Yanagida for their skillful experimental assistance, Ms. Linda Gudex for assistance in preparing the manuscript, and Dr. Thierry Burnouf for his valuable discussions to improve the final manuscript.

Conflict of interest

All of the authors are employees of Asahi Kasei Medical and its related company.

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