The Relationship among Pore-Size Ratings, Bubble Points, and Porosity - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Relationship among Pore-Size Ratings, Bubble Points, and Porosity


Pharmaceutical Technology


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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here