Sterilization validation

Pharmaceutical Process Validation: An International, An International Third Edition, Revised and Expanded

Volumn , Issue , 2003, Pages 83-157

  Akers, Michael J ^a   Anderson, Neil R ^b  

^a Baxter Pharmaceutical Solutions LLC   (United States)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056937841     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (80)

1. Mascoli, C. C. Should end-product sterility testing continue?Med Dev Diag Ind 3: 8-9(1981).
2. Bowman, F. W. The sterility testing of pharmaceuticals. J Pharm Sci 58:1301-1308(1969).
3. Ernst, R. R., West, K. L., Doyle, J. E. Problem areas in sterility testing. Bull Paren-ter Drug Assoc 23:29-39(1969).
4. Akers, M. J. In: Parenteral Quality Control: Sterility, Pyrogen, Particulate Matter and Package Integrity Testing, 2d edition. New York: Marcel Dekker, pp. 1-4(1994).
5. Brewer, J. H. In: G. L. Redish, ed.Antiseptics, Disinfectants, Fungicides, and Sterilization. 2nd ed. Philadelphia: Lea & Febiger, pp. 160-161 (1957).
6. Food and Drug Administration. Guideline on General Principles of Process Validation.Rockville, MD: FDA (1984).
7. Validation of Steam Sterilization Cycles. technical monograph no. 1. Parenteral Drug Association (1978).
8. Pflug, I. J., Holcomb, R. G. Principles of thermal destruction of microorganisms. In: S. S. Block, ed.Disinfection, Sterilization and Preservation. 4th ed. Philadelphia: Lea & Febiger, pp. 85-131 (1991).
9. Moats, W. A. Kinetics of thermal death of bacteria. J Bacteriol 105:165-171(1971).
10. Stumbo, C. R. Thermobacteriology in Food Processing.New York: Academic(1965).
11. Han, Y. W. Death rates of bacterial spores: Nonlinear survivor curves. Can J Microbio 21:1464-1467(1975).
12. Han, Y. W., Zhang, H. I., Krochta, J. M. Death rates of bacterial spores: Mathematical models. Can J Microbio 22:295-300(1976).
13. Validation of Dry Heat Processes Used for Sterilization and Depyrogenation. technical report no. 3. Parenteral Drug Association (1981).
14. Pflug, I. J. Sterilization: Science, not art. Med Dev Diag Ind 8-9 (March 1981).
15. Barry, I. R. Process validation: A U.S. viewpoint. Mfg Chem 34-35(Jan. 1983).
16. Witonsky, R. J. A new tool for the validation of the sterilization of parenterals. Bull Parenter Drug Assoc 31:274-281(1977).
17. Bunn, J. L., Sykes, I. K. A chemical indicator for the rapid measurement of F0 values. J Appl Bacteriol 51:143-174(1981).
18. Caputo, R. A., Mascoli, C. C. The design and use of biological indicators for sterilization-cycle validation. Med Dev Diag Ind 23(Aug. 1980).
19. Reich, R. R., Whitbourne, J. E., McDaniel, A. W. Effect of storage conditions on the performance of Bacillus stearothermophilus biological indicators. J Parenter Drug Assoc 33:228(1979).
20. Pflug, I. J. Monitoring the sterilization process. In: Syllabus for Introductory Course in the Microbiology and Engineering of Sterilization Processes. 2nd ed. Philadelphia: Parenteral Drug Association, pp. 19.2-19.4 (1978).
21. Simmons, P. L. Validation of dry heat sterilizers. Pharm Eng 38 (May-July 1981).
22. Simmons, P. L. Hot Air and Continuous Sterilization. Washington, D.C.: Pharmaceutical Manufacturers Association, p. 27 (1978).
23. Tsuji, K., Harrison, S. J. Dry-heat destruction of lipopolysaccharide: Dry heat destruction kinetics. Appl Environ Microbio 36:710-714(1978).
24. Akers, M. J., Avis, K. E., Thompson, B. Validation studies of the Fostoria infared tunnel sterilizer. J Parenter Drug Assoc 34:330-347(1980).
25. Wegel, S. Short time sterilization of glass materials under ultraclean conditions. Bull Parenter Drug Assoc 23:122-135(1974).
26. Akers, M. J., Ketron, K., Thompson, B. F value requirements for the destruction of endotoxin in the validation of dry heat sterilization/depyrogenation cycles. J Parenter Drug Assoc 36:23-27(1982).
27. Avis, K. E., Jewell, R. C., Ludwig, J. D. Studies on the thermal destruction of Escherichia coli endotoxin. J Parenter Drug Assoc 41:49(1987).
28. Ludwig, J. D., Avis, K. E. Validation of a heating cell for precisely controlled studies on the thermal destruction of endotoxin in glass. J Parenter Drug Assoc 42:9(1988).
29. Ludwig, J. D., Avis, K. E. Recovery of endotoxin preparations from the surface of glass capilliary tubes. J Parenter Drug Assoc 43:276(1989).
30. Ludwig, J. D., Avis, K. E. Dry heat inactivation of endotoxin on the surface of glass. J Parenter Drug Assoc 44:4(1990).
31. Robertson, J. H., Townsend, M. W., Allen, P. M., et al. Validation of ethylene oxide sterilization cycles. Bull Parenter Drug Assoc 31:265-273(1977).
32. Valenti, L. A validation program for ETO sterilization. Med Dev Diag Ind 1:15(1979).
33. Halleck, F. E. Principles for the validation of ethylene oxide sterilization cycles. Med Dev Diag Ind 2:27(1980).
34. Simmons, P. L. ETO sterilizer validation. Pharm Eng 1:13(1981).
35. Caputo, R. A., Rohn, K. J., Macoli, C. C. Biological validation of an ethylene oxide sterilization process. Dev Indus Microbio 22:357-362(1981).
36. Edwards, L. M., Childers, R. W. Hydrogen peroxide vapor sterilization: Applications in the production environment. In. M. J. Groves and R. Murty, eds. Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s. Buffalo Grove, IL: Interpharm Press, pp. 415-466 (1995).
37. Silverman, G. J. Sterilization by ionizing radiation. In: S. S. Block, ed.Disinfection, Sterilization and Preservation. 4th ed. Philadelphia: Lea & Febiger, pp. 566-579(1991).
38. ISO 11137:1995. Sterilization of health care products—Requirements for validation and routine control—Radiation sterilization. Arlington, VA: Association for the Advancement of Medical Instrumentation (AAMI) (2000).
39. Health Industry Manufacturers Association. Medical Device Sterilization Monographs, Sterilization Cycle Development. report no. 78-4.2 (1978).
40. Shoemaker, W. In: W. Shoemaker, ed.What the Filter Man Needs to Know About Filtration, AICHE Symposium Series, no. 171, vol. 73. New York: AICHE, pp. 1-3 (1977).
41. Meltzer, T. H., Jornitz, M. W. Filtration in the Biopharmaceutical Industry.New York: Marcel Dekker (1998).
42. Fed Reg 41 (106):2214 (June 1, 1976).
43. Food and Drug Administration. Guidelines on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD: FDA (1987).
44. Wallhausser, K. H. J. Parenter Drug Assoc 33(3):156 (1979).
45. Lukaszewicz, R. C., Meltzer, T. H. J Parenter Drug Assoc 33(5):246 (1979).
46. Osumi, M., Yamada, N., Toya, M. Bacterial retention mechanisms of membrane filters. J Pharm Sci Tech 50:30-34(1996).
47. Calvo, J. I., Hernandez, A., Pradanos, P., Martinez, L., Bowen, W. R. Pore size distributions in microporous membranes. J Colloid Interf Sci 176:467-478(1995).
48. Thomas, A. J., Durrheim, H. H., Alport, M. J. Validation of filter integrity by measurement of the pore-distribution function. Pharm Tech 16;32-43(1992).
49. Lukaszewicz, R. C., Tanny, G. B., Meltzer, T. H. Pharm Tech 2(11):77 (1978).
50. Howard, G. Jr., Duberstein, R. J Parenter Drug Assoc 34(2):95 (1980).
51. Sterilizing Filtration of Liquids. technical report no. 26. Parenteral Drug Association (1998).
52. MacDonald, W. D., Pelletier, C. A., Gasper, D. L. Practical methods for the microbial validation of sterilizing-grade filters used in aseptic processing. J Parenter Sci Tech 43:268-270(1989).
53. Lukaszewicz, R. C., Meltzer, T. H. J Parenter Drug Assoc 33(4):187 (1979).
54. Jacobs, S. Filtration and Separation9(5):525 (1972).
55. Jornik, M. W., Agalloco, J. P., Akers, J. E., Madsen, Jr., R. E., and Meltzer, T. H. PDA J. Pharm Sci Tech56(1) 4-10, (2002).
56. Johnston, P. R., Lukaszewicz, R. C., Meltzer, T. H. J Parenter Sci Tech 34(10):36 (1981).
57. Meltzer, T. H., Meyers, T. R. Bull Parenter Drug Assoc 25(4):165 (1971).
58. Olson, W. P., Martinez, E. D., Kern, C. R. J Parenter Sci Tech 35(5):215 (1981).
59. American Society for Testing and Materials. Standard Test Method for Pore Size Characteristics of Membrane Filters for Use with Aerospace Fluids. ASTM F316-80, part 25. Philadelphia: pp. 872-878 (1981).
60. Reti, A. R. Bull Parenter Drug Assoc 31(4):187 (1977).
61. Schroeder, H. G., DeLuca, P. P. Pharm Tech 4:80(1980).
62. Olson, W. P., Briggs, R. O., Garanchon, C. M., et al. J Parenter Drug Assoc 34(4): 254(1980).
63. Sterilizing Filtration of Liquids. technical report no. 26. PDA J Pharm Sci Tech 52:S1 (1998).
64. Reti, A. R., Leahy, T. J. J Parenter Drug Assoc 33(5):257 (1979).
65. Leahy, T. J., Sullivan, M. J. Pharm Tech 2(11):65 (1978).
66. Price, J. M., Pauli, W. A. Bull Parenter Drug Assoc 30(1):45 (1976).
67. Stone, T. E., Goel, V., Leszczak, J. Methodology for analysis of filter extractables: A model stream approach. Pharm Tech 18:116(1994).
68. Johnston, P. R., Meltzer, T. H. Pharm Tech 3(11):66(1979).
69. Meltzer, T. H., Jornitz, M. W. Filtration in the Biopharmaceutical Industry.New York: Marcel Dekker (1998).
70. Reif, O. W., Solkner, P., Rupp, J. Analysis and evaluation of filter cartridge extractables for validation in pharmaceutical downstream processing. J Pharm Sci Tech 50:399-410(1996).
71. Stone, T. E., Goel, V., Leszczak, J. Methodology for analysis of filter extractables: A model stream approach. Pharm Tech 18:116(1994).
72. Pall, D. B., Kirnbauer, E. A. Bacterial removal prediction in membrane filters. Proceedings of 52nd Colloid and Surface Science Symposium, University of Tennessee, Knoxville, June 12, 1980.
73. Validation of Aseptic Filling for Solution Drug Products. technical monograph no. 2. Philadelphia: Parenteral Drug Association, pp. 16-21 (1980).
74. U.S. Food and Drug Administration. proposed revised Guidelines on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD: FDA (Nov. 30, 1998).
75. Carleton, F. J., Agalloco, J. P. Validation of Aseptic Pharmaceutical Processes. New York: Marcel Dekker (1986).
76. Hofmann, K. L. Sterile products validation. In: I. R. Berry, R. A. Nash, eds. Pharmaceutical Process Validation. 2nd ed. New York: Marcel Dekker, pp. 89-166 (1993).
77. Cloud, P. A. Pharmaceutical Equipment Validation—The Ultimate Qualification Guidebook.Englewood, CO: Interpharm Press (1998).
78. DeSain, C., Sutton, C. Facility qualification studies. Biopharm 38-41(Jan. 1998).
79. Collentro, W. V. Pharmaceutical Water—System Design, Operation, and Validation.Englewood, CO: Interpharm Press (1998).
80. Anderson, N. R. Container cleaning and sterilization. In: W. P. Olson, M. J. Groves, eds.Aseptic Pharmaceutical Processing.Prairie View, IL: Interpharm Press (1987).