Grow-Through and Penetration of the 0.2/0.22 "Sterilizing" Membranes - Pharmaceutical Technology

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Grow-Through and Penetration of the 0.2/0.22 "Sterilizing" Membranes

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1. US Food and Drug Administration, FDA Guidance Document: Current Good Manufacturing Practice in the Manufacture, Processing, Packing, or Holding of Large Volume Parenterals for Human Use (FDA, Rockville, MD, 1976).

2. K.H. Wallhäusser, "Grow-Through and Blow-Through Effects in Long-Term Sterilization Processes," Die Pharmazeutische Industrie 45 (5), 527–531 (1983).

3. J.A. Simonetti and H.G. Schroeder, "Evaluation of Bacterial Grow-Through," J. Environ. Sci. 27 (6), 27–32 (1984).

4. D.A. Christian and T.H. Meltzer, "The Penetration of Membranes by Organism Grow-Through and Its Related Problems," Ultrapure Water 3 (3), 39–44 (1986).

5. 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, NY, 1998).

6. J.W. Carter, "Membrane Techniques (Reverse Osmosis and UltraFiltration)," in Towards Absolute Water, A Survey of Current Water Purification, Proceedings of International Symposium (Lane End, High Wycombe, Bucks, England, May 1976), pp. 103–114.

7. PDA–FDA Special Scientific Forum, "Validation of Microbial Retention of Sterilizing Filters," Bethesda, Maryland, July 12–13, 1995.

8. T.J. Leahy and M.J. Sullivan, "Validation of Bacterial Retention Capabilities of Membrane Filters," Pharm. Technol. 2 (11), 64–75 (1978).

9. S. Sundaram, "Retention of Diminutive Water-Borne Bacteria by Microporous Membrane Filters," presented at the PDA National Meeting, Washington, DC, Dec. 7, 1999.

10. V. Krygier, "Rating of Fine Membrane Filters Used in the Semiconductor Industry," in Transcripts of the Fifth Annual Semiconductor Pure Water Conference (San Francisco, CA, Jan. 1986), pp. 232–251.

11. K. Kawamura, M.W. Jornitz, and T.H. Meltzer, "Absolute or Sterilizing Grade Filtration—What is Required?" PDA J. Paren. Sci. Technol. 54 (6), 485–492 (2000).

12. 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).

13. M.W. Jornitz and T.H. Meltzer, "Sterilizing Filtrations with Microporous Membranes," Pharm. Forum 30 (5), 2–9 (2004).


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