Validation of moist heat sterilization processes: Cycle design, development, qualification and ongoing control

PDA Journal of Pharmaceutical Science and Technology

Volumn 61, Issue SUPPL. 1, 2007, Pages 1-51

  Agalloco, James P ^a   Akers, James E ^b   Allinson, Wilf ^c   Berger, Thomas J ^d   Bing, Frank ^e   Bringert, Göran ^f   Butler, Gary ^g   Clavelin, Jean Luc ^h   Cooney, Peter ⁱ   DeSantis, Phil ^d   Dürr, Peter ^j   Evans, Kristen D ⁱ   Grazal, John G ^k   Halls, Nigel ^l   Hargreaves, Paul ^d   Hopkins, Andrew D ^d   Joyce, Martin A ^m   Karle, David ^g   Kronenberg, Bernard ⁿ   Levchuk, John W ⁱ   Levy, Richard V ^d   Loevtrup, Steen ^o   Lord, Timothy F ^h   Lovitt Wood, Genevieve ^p   Madsen, Russell E ^q   Mascherpa, Vittorio ^d   Maynard, David W ^r   Myers, Robert B ^d   Owens, James E ^s   Pflug, Irving ^t   Pistolesi, Dario ^d   Pochiro, Anthony ^u   Saari, Jarmo ^d   Sadowski, Michael ^s   Shirtz, John T ^s   Shuttleworth, Keith ^v   Skinner, Finlay ^d   Symonds, Ian ^c   Trupp, Kevin D ^d   Witthauer, Dieter ^d   Wood, Richard T ^d   Young, William ^s   more..

^a AGALLOCO AND ASSOCIATES   (United States)

^b Akers Kennedy and Associates   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d Hospira ^*

^e ABBOTT LABORATORIES   (United States)

^f GE Kaye Instruments

^g STERIS Corporation   (United States)

^h ELI LILLY AND COMPANY   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j F HOFFMANN LA ROCHE LTD   (Switzerland)

^k ASTRAZENECA   (United Kingdom)

^l IAGT Ltd

^m GeneraMedix Inc

ⁿ PDA   (Switzerland)

^o NOVO NORDISK A S   (Denmark)

^p GI Lovitt and Associates

^q Williamsburg Group LLC   (United States)

^r Baxter Healthcare   (United States)

^s BAXTER HEALTHCARE CORPORATION   (United States)

^t UNIVERSITY OF MINNESOTA   (United States)

^u AG Edwards and Sons

^v Keith Shuttleworth and Associates Ltd

more..

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIUM CONTAMINATION; DISINFECTION; HEAT; INSTRUMENT STERILIZATION; LETHALITY; LIQUID; MOIST HEAT STERILIZATION; PHYSICAL CHEMISTRY; POROSITY; PRESSURE; PROCESS CONTROL; PROCESS DESIGN; PROCESS MODEL; PROCESS MONITORING; PROCESS TECHNOLOGY; REVIEW; SOLID; SURFACE PROPERTY; TEMPERATURE; THERMAL CONDUCTIVITY; THERMAL EXPOSURE; VALIDATION PROCESS; WATER VAPOR;

EID: 35348997080     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (40)

1. ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.3
2. ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.6
3. Derived from ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.6
4. USP 30, NF-25, 〈1231〉 Water for Pharmaceutical Purposes (2007) pp 687-706
5. ISO 18472:2006, Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment, Definition 3.11
6. ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.46
7. ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.51
8. ISO/TS 11139:2006, Sterilization of Health Care Products - Vocabulary. Definition 2.52
9. Rahn, Injury and Death of Bacteria by Chemical Agents, Biodynamica, Normandy, Mo., (1945)
10. Pflug, I. J. and Holcomb, R. G., Gomez, M., Chapter 6, Principles of the Thermal Destruction of Microorganisms, Disinfection, Sterilization, and Preservation, Fifth Edition, S. S. Block, Editor, Lippincott Williams & Wilkins (2000) pp 79-129
11. USP 30, NF-25 〈55〉 Biological Indicators-Resistance Performance Tests (2007) pp 81-83
12. ISO 11138-1:2006 Sterilization of Health Care Products - Biological Indicators
13. Pflug, I.J., Chapter 7, Analysis of Microbial-Survivor Data, Microbiology and Engineering of Sterilization Processes, 12th Edition, Parenteral Drug Association (2007)
14. Stumbo, C.R., Murphy, J.R., Cochran, J., Nature of Thermal Death Time Curves for P.A. 3679 and Clostridium botulinum. Food Res. (3), (1950) pp 323-346
15. Halvorson, H.O., Ziegler, N.R., Applications of Statistics to Problems in Bacteriology, Journal Bacteriology 25, (1933) pp 101-121
16. Pflug, I.J., Microbiology and Engineering of Sterilization Processes, 12th Edition, Parenteral Drug Association (2007)
17. Pflug, I.J., Chapter 6, Gathering Experimental Microbial-Kill Data, Microbiology and Engineering of Sterilization Processes, 12th Edition, Parenteral Drug Association (2007)
18. Fundamental Process Control Theory, Instrumentation Society of America (1981)
19. Kemper, C. and Harper, G., Probe Induced Errors, Pharmaceutical Technology (1978)
20. Reed, R.P., Thermoelectric in Homogeneity - Obscure Obstacle to Quality, National Conference of Standards Laboratories, Albuquerque, N. Mex. (1998)
21. Pflug, I.J., Chapter 10, General Method of Heat-Process Evaluation, Microbiology and Engineering of Sterilization Processes, 12th Edition, Parenteral Drug Association (2007)
22. USP 30, NF-25, 〈1035〉 Biological Indicators for Sterilization (2007)
23. ISO 18472:2006, Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
24. FDA, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (2004)
25. Berger, T.J., Nelson, P.A., The Effect of Formulation of Parenteral Solutions on Microbial Growth - Measurement of D- and z-values, PDA Journal of Pharmaceutical Science and Technology 49 (1), (1995) pp 32-41
26. Russell, Allan D., Chapter 3, Principles of Antimicrobial Activity and Resistance, Disinfection, Sterilization and Preservation, Fifth Edition, S. S. Block, Editor, Lippincott Williams & Wilkins (2000) pp 31-55
27. Derived from: IAPWS-IF97, SI units, Chapter 3, ASME International Steam Tables for Industrial Use, The American Society of Mechanical Engineers, 58 (2000) page 16
28. Derived from: IAPWS-IF97, SI units, Chapter 3, ASME International Steam Tables for Industrial Use, The American Society of Mechanical Engineers, 58 (2000), page 16
29. Derived from: IAPWS-IF97, SI units, Chapter 3, ASME International Steam Tables for Industrial Use, The American Society of Mechanical Engineers, Volume 58 (2000), page 16
30. Pflug, I.J., Procedures for Carrying Out Heat Penetration Tests and Analysis of the Resulting Data, Department of Food, Science and Nutrition, University of Minnesota, Minneapolis, Minn. (1975)
31. USP 30, NF-25, 〈 1231 〉 Water for Pharmaceutical Purposes (2007)
32. EN 285, Sterilization - Steam Sterilizers - Large Sterilizers, CEN European Committee for Standardisation (1996)
33. Shuttleworth, K., Application of Steam Quality Test Limits - European Journal of Parenteral Sciences, 4 (109) (2000)
34. Decision Tree for the Selection of Sterilisation Methods, Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/054/98 Corr), EMEA, April 2000
35. Joyce, M.A. and Lorenz, J.W., Internal Pressure of Sealed Containers During Autoclaving, PDA Journal of Pharmaceutical Science and Technology 44 (6) (1990) pp 320-323
36. Allwood, M.C., Hambleton, R. and Beverley, S., Pressure Changes in Bottles During Sterilization by Autoclaving, PDA Journal of Pharmaceutical Science and Technology 64 (2), (1975) pp 333-334
37. Halls, N.A., Achieving Sterility in Medical and Pharmaceutical Products, New York: Marcel Dekker, Inc. (1994)
38. Agalloco, J., The Validation of Life Cycle, PDA Journal of Pharmaceutical Science and Technology, 47 (3) (1993)
39. Evans, K., Pflug, I.J., Carrying Out Biological Qualification, The Control Operation of Moist-Heat (Steam Sterilization) Processes for Producing Sterile Pharmaceuticals and Medical Devices, PDA Journal of Pharmaceutical Science and Technology, 54 (2) (2000) pp 117-135
40. Pflug, I.J., Chapter 17B, Microbial Control in Pharmaceuticals and Medical Devices using Moist Heat (Steam Autoclave), Microbiology and Engineering of Sterilization Processes, 12th Edition, Parenteral Drug Association (2007)