Research ArticleTECHNOLOGY/APPLICATION
Critical Influences of Particles, Pores, and Prefilters in Sterilizing Filtration
Russell E. Madsen and Theodore H. Meltzer
PDA Journal of Pharmaceutical Science and Technology May 2009, 63 (3) 240-244;
References
- 1.↵
- Ruth B. F.,
- Montillon G. H.,
- Montanna R. E.
- 2.↵
- Hermans P. H.,
- Bredee H. L.
- 3.↵
- Tanny G. B.,
- Strong D. K.,
- Presswood W. G.,
- Meltzer T. H.
- 4.↵
ASTM Standard F 316-03. Standard test methods for pore size characteristics of membrane filters by bubble point and mean flow pore test. ASTM International: West Conshohocken, PA, 2003.
- 5.↵
- Hofmann F.
- 6.↵
- Kesting R. E.,
- Murray A. S.,
- Jackson K.,
- Newman J. M.
- 7.↵
CPMP/QWP/486/95. CPMP note for guidance on manufacture of the finished dosage form. The European Agency for the Evaluation of Medicinal Products: London, 1996.
- 8.↵
Guideline on sterile drug products produced by aseptic processing. CDER/CBER/ORA, Food and Drug Administration: Rockville, MD, 1987.
- 9.↵
Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. CDER/CBER/ORA, Food and Drug Administration: Rockville, MD, 2004.
- 10.↵
- Wallhäusser K. H.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 3
May/June 2009
Critical Influences of Particles, Pores, and Prefilters in Sterilizing Filtration
Russell E. Madsen, Theodore H. Meltzer
PDA Journal of Pharmaceutical Science and Technology May 2009, 63 (3) 240-244;
Jump to section
- Article
- Abstract
- Introduction
- Pore-Size and Particle-Size Distributions
- Small Particle Penetrations
- Particle Retention Mechanisms
- The Mean Flow-Pore
- The Mix of Pores and Particles
- Prefilters and Post-Filtration Integrity Testing
- Prefilters and Sterility Assurance
- Relevance to Regulatory Views
- Summary and Conclusion
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.