Filter Integrity Testing in the Pharmaceutical Process Environment - Automating filter integrity testing helps to ensure that GMP sterility requirements are met. - BioPharm International

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Filter Integrity Testing in the Pharmaceutical Process Environment
Automating filter integrity testing helps to ensure that GMP sterility requirements are met.


BioPharm International
Volume 19, Issue 6

Reinhard Baumfalk, Ph.D., is head of systems development of the Biotechnology Division, Sartorius AG, Weender Landstrasse 94-108, D-37075 Göttingen, Germany, +49 551.308.3984 fax +49 551.308.3289,

Jerry Finazzo is product manager of process filtration integrity testing at Sartorius North America, Inc. , 131 Heartland Blvd., Edgewood NY 11717, 631.254.4249 X8375, fax 631.253.5475,

REFERENCES

1. American Society for Testing and Materials. "Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration." ASTM F-838-83. Philadelphia, PA 1993.

2 European Commission. "Guide to good manufacturing practice, Annex 1." Brussels, Belgium 2003.

3. European Medicines Agency. cGMP Note for Guidance on Manufacture of the Finished Dosage Form. London 1996 April Reissue:5-6.

4. Jornitz MW (editor). Advances in Biochemical Engineering/Biotechnology. Sterile Filtration. Vol. 98, Chap. 6. Springer Verlag. Berlin. 2006.

5. Sterilizing Filtration of Liquids. Parenteral Drug Association Technical report #26 PDA J. Pharm. Sci. Technol. 1998; 52 Suppl 1:1-31.

6. Dosmar M, Wolber P, Bracht K, Tröger H, Waibel P. The water pressure integrity test — A new integrity test for hydrophobic membrane filters. Journal of Parenteral Science & Technology. 1992 July-Aug 46(4):102-6.

7. McBurnie L and Bardo B, Validation of sterile filtration. Pharmaceutical Technology, 2004 October.

8. GAMP Guide. Validation of automated systems in pharmaceutical manufacture; Version 4.0; ISPE and GAMP Forum; 2002. Available at: http://www.ispe.org/gamp/.

9. GAMP Good Practice and Compliance for Electronic Records Series: Complying with 21 CFR Part 11, Part 2. ISPE/GAMP Forum & PDA; 2002.

10. FDA. Guidance for Industry: 21 CFR Part 11. Electronic records; Electronic signatures — Scope and application. Pharmaceutical CGMPs. Bethesda Md. 2003 August.

11. Jornitz MW and Meltzer TH. Filtration handbook – Integrity testing. Parenteral Drug Association. Bethesda Md. 2003 January.


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