19. H.G. Schroeder, Selection Criteria For Selection of Sterilizing Grade Filters (Society of Manufacturing Engineers, Philadelphia, PA, 1984).
20. W. Wrasidlo et al., "Effect of Vehicle Properties on the Retention Characteristics of Various Membrane Filters" presented at PDA Spring Meeting,
San Juan, PR, 1983.
21. D.L. Tolliver and H.G. Schroeder, "Particle Control in Semiconductor Process Streams," Microcontamination
1 (1), 34–43 and 78 (1983).
22. S.F. Emory et al., "The Effects of Surfactant Type and Latex-Particle Feed Concentration on Membrane Retention," Ultrapure Water
10 (2), 41–44 (1993).
23. S. Sundaram et al., "Application of Membrane Filtration for Removal of Diminutive Bioburden Organisms in Pharmaceutical Products and Processes,"
PDA J. Pharm. Sci. Technol. 53 (4), 186–301 (1999).
24. R.C. Lukaszewiez and T.H. Meltzer, "On the Structural Compatibilities of Membrane Filters," J. Paren. Drug Assoc.
34 (6), 463–472 (1980).
25. D.B. Pall and E.A. Kirnbauer, "Bacteria Removal Prediction in Membrane Filters" presented at 52d Colloid and Surface Symposium,
University of Tennessee, Knoxville, TN (1978).
26. H.G. Schroeder, "Rationalization and Valid Scale-Up of Integrity Test Parameters for Sterilizing-Grade Filter Cartridges,"
Pharm. Technol.
55 (2), 134–142 (2001).
27. ASTM Committee F-838, Bacterial Retention of Membrane Filters Utilized For Liquid Filtration (American Society for Testing and Materials, West Conshohoken, PA, 1988).
28. J. Lindenblatt, M.W. Jornitz, and T.H. Meltzer, "Filter Pore Size Versus Process Validation: A Necessary Debate," Eur. J. Paren. Sci.
7 (3), 67–71 (2002).
29. M.W. Jornitz et al., "Testing for the Optimal Filter Membrane: Required Prerequisites," Genetic Eng. News 24 (13), (2004).
30. J.G. Howard and R. Duberstein, "A Case of Penetration of 0.2 μm-rated Membrane Filters by Bacteria," J. Paren. Drug Assoc.
34, 95–102 (1980).
31. T.J. Leahy and M.J. Sullivan, "Validation of Bacterial Retention Capabilities of Membrane Filters," Pharm. Technol. 2 (11), 64–75 (1978).
32. M.J. Gould, M.A. Dawson, and T.J. Novitsky, "Evaluation of Microbial/Endotoxin Contamination Using the LAL Test," Ultrapure Water
10 (6), 43–47 (1993)
33. F.M. Leo et al., "Application of 0.1 Micron Filtration for Enhanced Sterility Assurance on Pharmaceutical Filling Operations," BFS News (a publicaiton of the Pall Corporation), 15–24 (1997)
34. T.H. Meltzer, M.W. Jornitz, and A.M. Trotter, "Application-Directed Selection 0.1 μm or 0.2 μm Rated Sterilizing Filters,"
Pharm. Technol.
22 (9), 116–122 (1998).
|
