Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products

Vaccine

Volumn 29, Issue 45, 2011, Pages 8012-8023

  Parveen, Seema ^a   Kaur, Simleen ^a   David, Selwyn A Wilson ^a   Kenney, James L ^a   McCormick, William M ^a   Gupta, Rajesh K ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

ATP bioluminescence technology; Detection of growth by CO 2 monitoring; Rapid microbiological methods; Sterility method

Indexed keywords

ADENOSINE TRIPHOSPHATE; ALUMINUM HYDROXIDE; ALUMINUM PHOSPHATE; BIOLOGICAL PRODUCT; CARBON DIOXIDE; INFLUENZA VACCINE; REAGENT; THIOGLYCOLIC ACID; THIOMERSAL; VACCINE;

AGAR MEDIUM; ARTICLE; BIOLUMINESCENCE; COLONY FORMING UNIT; CULTURE MEDIUM; DRUG CONTAMINATION; DRUG STERILITY; HYBRID RAPID MILLIFLEX DETECTION SYSTEM; INOCULATION; INTERMETHOD COMPARISON; MEMBRANE FILTER; MICROBIAL GROWTH; NONHUMAN; PRIORITY JOURNAL; SABOURAUD DEXTROSE AGAR; SCHAEDLER BLOOD AGAR; TRYPTIC SOY AGAR; TURBIDITY;

ADENOSINE TRIPHOSPHATE; BACTERIA; BIOLOGICAL AGENTS; CARBON DIOXIDE; CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG CONTAMINATION; FUNGI; MICROBIOLOGICAL TECHNIQUES; SENSITIVITY AND SPECIFICITY; TECHNOLOGY, PHARMACEUTICAL; VACCINES;

EID: 80053630532     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.08.055     Document Type: Article

References (38)

1. Code of Federal Regulations, Title 21 Food and Drugs, Part 610.12 Sterility testing. Washington, DC: US Government Printing Office; April 2010.
2. USP <71> Sterility Tests. Pharmacopeial Forum USP 33-NF 28. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 2011.
3. Bowmann F.W. The Sterility testing of pharmaceuticals. J Pharm Sci 1969, 58:1301-1308.
4. Clausen O.G. A study of the growth-promoting properties of fluid and solid microbial-contamination test media on small numbers of microorganisms. Pharm Acta Helv 1973, 48:541-548.
5. Abdou M.A.F. Comparative study of seven media for sterility testing. J Pharm Sci 1974, 63:23-26.
6. Stannard C.J., Gibbs P.A. Rapid microbiology: application of bioluminescence in the food industry - a review. J Biolumin Chemilumin 1986, 1:3-10.
7. Thorpe T.C., Wilson M.L., Turner J.E. BacT/ALERT: an automated colorimetric microbial detection system. J Clin Microbiol 1990, 28:1608-1612.
8. Nolte F.J.M., Williams R.C., Jerris J.A., Morello C.D., Matushek L.S., Schwabe L.D., et al. Multicenter clinical evaluation of a continuous monitoring blood culture system using fluorescent-sensor technology (BACTEC 9240). J Clin Microbiol 1993, 31:552-557.
9. Walner G., Tillmann D., Haberer K. The ChemScan system: a new method for rapid microbiological testing of water. Eur J Parenter Sci 1997, 2:89-126.
10. Moldenhauer J. Overview of rapid microbiological methods. Principles of bacterial detection: biosensors, recognition receptors and microsystems 2008, 49-79. Springer, New York. M. Zourob, S. Elwary, A. Turner (Eds.).
11. ® Rapid Microbiology Detection and Enumeration system. J Rapid Methods Autom Microbiol 2008, 16:256-272.
12. Khuu H.M., Stock F., McGann M., Carter C.S., Atkins J.W., Murray P.R., et al. Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products. Cytotherapy 2004, 6:183-195.
13. Kielpinski G., Prinzi S., Duguid J., Moulin G.du. Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel autologous cultured chondrocytes. Cytotherapy 2005, 7:531-541.
14. London R., Schwedock J., Sage A., Valley H., Meadows J., Waddington M., et al. An automated system for rapid non-destructive enumeration of growing microbes. PLoS 2010, 5:1-16.
15. Gray J.C., Staerk A., Berchtold M., Hecker W., Neuaus G., Wirth A. Growth-promoting properties of different solid nutrient media evaluated with stressed and unstressed micro-organisms: prestudy for the validation of a rapid sterility test. PDA J Pharm Sci Technol 2010, 64:249-263.
16. Gray J.C, Morandell D., LeGoff N., Neuhaus G., Staerk A. Identification of microorganisms after Milliflex Rapid Detection - a possibility to identify nonsterile findings in the Milliflex Rapid sterility test. PDA J Pharm Sci Technol 2011, 65:42-54.
17. Sutton S.V.W., Moldenhauer J. Towards an improved sterility test. J Pharm Sci Technol 2004, 58:284-286.
18. Riley B.S. Rapid microbiological methods in the pharmaceutical industry. Am Pharm Rev 2004, (March/April):1-4.
19. Gressett G., Vanhaecke E., Moldenhauer J. Why and how to implement a rapid sterility test. PDA J Pharm Sci Technol 2008, 62:429-444.
20. Bussey D.M., Tsuji K. Bioluminescence for USP sterility testing of pharmaceutical suspension products. Appl Environ Microbiol 1986, 51:349-355.
21. Weinstein M.P., Mirrett S., Reimer L.G., Wilson M.L., Smith-Elekes S., Chuard C.R., et al. Controlled evaluation of BacT/Alert standard aerobic and FAN aerobic blood culture bottles for detection of bacteremia and fungemia. J Clin Microbiol 1995, 33:978-981.
22. Reisner B.S., Woods G.L. Times to detection of bacteria and yeasts in BACTEC 9240 blood culture bottles. J Clin Microbiol 1999, 37:2024-2026.
23. Carricajo A., Fonsale N., Vautrin A.C., Aubert G. Evaluation of BacT/Alert 3D liquid culture system for recovery of mycobacteria from clinical specimens using sodium dodecyl (lauryl) sulfate-NaOH decontamination. J Clin Microbiol 2001, 39:3799-3800.
24. Reimer L.G., Wilson M.L., Weinstein M.P. Update on detection of bacteremia and fungemia. Clin Microbiol Rev 1997, 10:44-465.
25. Fuller D.D., Davis T.E. Comparison of BACTEC Plus Aerobic/F, Anaerobic/F Peds Plus/F, and Lytic/F media with and without fastidious organism supplement to conventional methods for culture of sterile body fluids. Diagn Microbiol Infect Dis 1997, 29:219-225.
26. Bourbeau P., Riley J., Heiter B.J., Bourbeau P., Riley J., Heiter B.J., et al. Use of the BacT/Alert blood culture system for culture of sterile body fluids other than blood. J Clin Microbiol 1998, 36:3273-3277.
27. Simor A.E., Scythes K., Meaney, Loui M. Evaluation of the BacT/Alert microbial detection system with FAN aerobic and FAN anaerobic bottles for culturing normally sterile body fluids other than blood. Diagn Microbiol Infect Dis 2000, 37:5-9.
28. Riedel S., Siwek G., Beekmann S.E., Richter S.S., Raife T., Doern G.V. Comparison of the BACTEC 9240 and BacT/Alert blood culture systems for detection of bacterial contamination in platelet concentrates. J Clin Microbiol 2006, 44:2262-2264.
29. Costanzo S.P., Borazjani R.N., McCormick P.J. Validation of the Scan RDI for routine microbiological analysis of process water. PDA J Pharm Sci Technol 2002, 56:206-219.
30. Smith R., Tress V.M., Tubb C., Vanhaecke E. Evaluation of the ScanRDI as a rapid alternative to the pharmacopeial sterility test method: comparison of the limits of detection. PDA J Pharm Sci Technol 2010, 64:356-363.
31. Akers J., Agalloco J. Sterility and sterility assurance. PDA J Pharm Sci Technol 1997, 51:72-77.
32. Bill A. Microbiology laboratory methods in support of the sterility assurance system. Handbook of microbiological quality control pharmaceutical and medical devices 2000, 120-143. CRC press. R.M. Baird, N.A. Hodges, S.P. Denyer (Eds.).
33. Baird R.M. Sterility assurance: concepts methods and problems. Principle and practice of disinfection, preservation and sterilization 2004, 526-539. Blackwell Pub. A.P. Fraise, P.A. Lambert, J.Y. Maillard (Eds.).
34. Hernandez-Lopez J., Guzman-Murillo M.A., Vargas-Albores F. Quantification of pathogenic marine vibrio using membrane filter technique. J Microbiol Methods 1995, 21:143-149.
35. Simidu U., Lee W.J., Kogure K. Comparison of different techniques for determining plate counts of marine bacteria. Bull Jpn Soc Sci Fish 1983, 49:1199-1203.
36. Starr S.E., Killgore G.E., Dowell V.T. Comparison of Schaedler agar and trypiticase Soy-Yeast extract agar for the cultivation of anaerobic bacteria. Appl Microbiol 1971, 22:655-658.
37. Code of Federal Regulations, Title 21 Food and Drugs, Part 610.9 Equivalent Methods and Processes. Washington, DC: US Government Printing Office; April 2010.
38. USP <1223> Validation of alternative microbiological methods. Pharmacopeial Forum USP 33-NF 28. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 2011.