Validation of filtration

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Volumn , Issue , 2000, Pages 207-333

  Morris, Gregory M ^a   Rozembersky, John ^b   Schwartz, Larry ^a  

^a PALL CORPORATION   (United States)

^b Pall Filtron   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77958572756     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/9780849398582     Document Type: Chapter

References (15)

1. NP Cheremisinoff, DS Azbel. Liquid Filtration. Woburn, MA: Ann Arbor Science, 1983.
2. M Cheryan. Ultrafiltration Handbook. Lancaster, PA: Technomic, 1986.
3. PR Johnston. Fluid Sterilization by Filtration: The Filter Integrity Test and Other Topics. Buffalo Grove, IL: Interpharm, 1997.
4. TH Meltzer. Filtration in the Pharmaceutical Industry. New York: Marcel Dekker, 1987.
5. TH Meltzer, MW Jomitz. Filtration in the Biopharmaceutical Industry. New York:Marcel Dekker, 1998.
6. LJ Zeman, AL Zydney. Microfiltration and Ultrafiltration, Principles and Applications. New York: Marcel Dekker, 1996.
7. JJ Errico. Validation of aseptic processing filters. In: FJ Carleton, JP Agalloco, eds. Validation of Aseptic Pharmaceutical Processes. New York: Marcel Dekker, 1986, pp 427-472.
8. CS Genovesi. Validation of unique filtration processes. In: FJ Carleton, JP Agalloco, eds. Validation of Aseptic Pharmaceutical Processes. New York: Marcel Dekker, 1986, pp 473-506.
9. JH Robertson, JD Wilson, F Bing, et al. Sterilizing Filtration of Liquids. Tech Rep 26, PDA. PDAJ Pharm Sci Tech 4(S1):1-31, 1998.
10. J Detyna. Adsorption validation for aseptic filtration. J Validation Tech 1(4):46-50, 1995.
11. S Sundaram. Protein adsorption in microporous membrane filtration. In: TH Meltzer, MW Jornitz, eds. Filtration in the Biopharmaceutical Industry. New York:Marcel Dekker, 1998, pp 533-575.
12. C Weitzmann. The use of model solvents for evaluating extractables from filters used to process pharmaceutical products. Pharm Tech 21(4):72-99, 1997.
13. United States Pharmacopeia. 24th revision. Rockville, MD: U.S. Pharmacopeial Convention, 1995.
14. FW Bowman, MP Calhoun, M White. Microbiological methods for quality control of membrane filters. J Pharm Sci 56:222-225, 1967.
15. JD Brantley, JM Martin. Integrity testing of membrane filters to assure production of sterile effluent. Genet Eng News, May 15, 1997, p 24.