Sterile double filtration

Pharmaceutical Technology

Volumn 22, Issue 10, 1998, Pages

  Jornitz, Maik W ^a   Meltzer, Theodore H ^b,c  

^a SARTORIUS STEDIM BIOTECH GMBH   (Germany)

^b Capitola Consulting Co   (United States)

^c Pharmaceutical Technology's Edit A ^*

Author keywords

[No Author keywords available]

Indexed keywords

BIOFILTER; BIOFILTRATION; GOOD LABORATORY PRACTICE; MICROORGANISM; NONHUMAN; PHARMACEUTICAL ENGINEERING; PROTOPLAST; REVIEW; VALIDATION PROCESS; WATER SUPPLY;

EID: 0005463070     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. W.P. Olson, "Sterilizing Filtrations: Process," in Sterilization of Drugs and Devices, F.M. Nordhauser and W.P. Olson, Eds. (Interpharm Press, Buffalo Grove, IL, 1998).
2. P. Hargreaves, "Paul Hargreaves Speaks Out on Pharmaceutical Manufacturing," PDA Letter 29, 10-13 (1993).
3. J.R. Carter and R.V. Levy, "Microbial Retention Testing in the Validation of Sterilizing Filtration," in Filtration in the Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds. (Marcel Dekker, New York, 1998), p. 600.
4. EMEA-CPMP Note for Guidance on Manufacture of the Finished Dosage Form, April 1996.
5. W.J. Elford, "The Principles of Ultrafiltration as Applied in Biological Studies," from Proceedings of Royal Society, Vol. 112B (London, 1933), pp. 384-406.
6. M.W. Jornitz and T.H. Meltzer, "Filtrative Particle Removal from Liquids," in Filtration in the Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds. (Marcel Dekker, New York, 1998), p. 259.
7. K.H. Wallhäusser, "New Investigations into Germ Removal Filtrations," Drugs Made in Germany 23, 10-15, 49-52 (1980).
8. K.H. Wallhäusser, "Bacteria Removal Filtration with Highly Asymmetric Filter Media," Pharm. Int., Special Printing (February 1983).
9. A.R. Reti, T.J. Leahy, and P.M. Meier, "The Retention Mechanism of Sterilizing and Other Submicron High-Efficiency Filter Structures," from Proceedings of the 2nd World Filtration Congress (London, 1979), pp. 427-435.
10. M.W. Jornitz and T.H. Meltzer, "Validation of Filtrative Sterilizations," in Filtration in the Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds. (Marcel Dekker, New York, 1998), p. 901.
11. T.J. Leahy and M.J. Sullivan, "Validation of Bacterial-Retention Capabilities of Membrane Filters," Pharm. Technol. 2 (11), 64-75 (1978).
12. J.W. Haycock et al., "Bacterial L Forms Are Omnipresent in 'Sterile' Tissue Culture Sera," private communication.
13. T.H. Meltzer, "Organisms and Their Control," in Pharmaceutical Water Systems (Tall Oaks Publishing Co., Littleton, CO, 1997).