Application-directed selection of 0.1-μm or 0.2-μm rated sterilizing filters

Pharmaceutical Technology

Volumn 22, Issue 9, 1998, Pages 116-122

  Meltzer, Theodore H ^a   Jornitz, Maik W ^b   Trotter, A Mark ^b  

^a Capitola Consulting Co   (United States)

^b SARTORIUS STEDIM BIOTECH GMBH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG INDUSTRY; FILTER; INSTRUMENT STERILIZATION; MEMBRANE FILTER; QUALITY CONTROL; STANDARD;

EID: 0031705375     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. FDA, "Guideline on Sterile Drug Products Produced by Aseptic Processing," Center for Drugs and Biologics, Rockville, MD, June 1987.
2. American Society for Testing and Materials (ASTM), "Standard Test Method for Determining Bacterial Retention of Membrane Filters Used for Liquid Filtration," ASTM Standard F838-83, ASTM, Philadelphia, PA (1983, revised 1988).
3. F.W. Bowman, M.P. Calhoun, and M. White, "Microbiological Methods for Quality Control of Membrane Filters," J. Pharm. Sci. 56 (2), 453-459 (1967).
4. EMEA-CPMP Note for Guidance on Manufacture of the Finished Dosage Form, April 1996.
5. G.B. Tanny et al., "The Adsorptive Retention of Pseudomonas diminuta by Membrane Filters," J. Parenteral Drug Assoc. 33 (1), 40-51 (1979).
6. G. Howard, Jr., and R. Duberstein, "A Case of Penetration of 0.2 μm-Rated Membrane Filters by Bacteria," J. Parenteral Drug Assoc. 34 (2), 95-102 (1980).
7. P. Hargreaves, "Paul Hargreaves Speaks Out on Pharmaceutical Manufacturing," PDA Letter 29, 10-13 (1993).
8. D.B. Pall, E.A. Kirnbauer, and B.T. Allen, "Particulate Retention by Bacteria Retentive Membrane Filters," Colloids and Surfaces 1, 235-256 (1980).
9. V. Krygier, "Rating of Fine Filter Membranes Used in the Semiconductor Industry," Transcripts of Fifth Annual Semiconductor Pure Water Conference, San Francisco, CA, January 1986, pp. 232-251.
10. J.H. Young, B.L. Ferko, and R.P. Gaber, "Parameters Covering Steam Sterilization of Deadlegs," J. Pharm. Sci. Technol. 48 (3), 140-147 (1994).
11. W. Steere and T.H. Meltzer, "Operational Considerations in the Steam Sterilization of Cartridge Filters," Pharm. Technol. 17 (9), 98-110 (1993).
12. T.D. Brock, Membrane Filtration: A User's Guide and Reference Manual (Science Tech, Inc., Madison, WI, 1983).