Rapid microbiological methods: Where are they now?

American Pharmaceutical Review

Volumn 14, Issue 7, 2011, Pages 18-25

  Duguid, John ^a   Balkovic, Edward ^a   Du Moulin, Gary C ^a  

^a A Sanofi Company   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE TRIPHOSPHATE; CARBON DIOXIDE;

ACCURACY; AUTOFLUORESCENCE; BIOLUMINESCENCE; COLONY FORMING UNIT; COST; DIRECT LASER SCANNING; DNA SEQUENCE; FLOW CYTOMETRY; FOOD AND DRUG ADMINISTRATION; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MICROBIAL GROWTH; MICROBIAL IDENTIFICATION; MICROBIOLOGICAL EXAMINATION; MICROORGANISM DETECTION; NONHUMAN; PHENOTYPE; POLYMERASE CHAIN REACTION; QUALITY CONTROL; REAL TIME POLYMERASE CHAIN REACTION; SHORT SURVEY;

EID: 84555218449     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (19)

1. Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme PE 012-3 Recommendation on Sterility Testing 25 September 2007.
2. Kielpinski G, Prinzi S, Duguid J, du Moulin GC. 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. (Pubitemid 43078083)
3. Miller MJ, ed. Encyclopedia of Rapid Microbiological Methods. River Grove, Ill: DHI Publishing, LLC; 2005.
4. Newby P. The Significance and Detection of VBNC Microorganisms. Eur. Pharm. Rev. 2007; 3:87-92.
5. Denoya C, Colgan S, du Moulin GC. Alternative Microbiological Methods in the Pharmaceutical Industry: The Need for a New Microbiology Curriculum. Am. Pharm. Rev. 2006; 9:10-18.
6. Cundell AM. Opportunities for Rapid Microbial Methods. Eur. Pharm. Rev. 2006; 1:64-70.
7. Equivalent methods and processes. In: Code of Federal Regulations. Title 21 §610.9; 2009.
8. Parveen S, Kaur S, David SA, Kenney JL, McCormick WM, Gupta RK. Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products. Vaccine. 2011 doi 10.1016/j.vaccine.2011.08.055.
9. Montag T, Nicol SB, Schurig U, Herden M, Huber H, Sanzenbacher R, Flory E, Schwanig M, Schneider CK. Microbial safety of cell based medicinal products--what can we learn from cellular blood components? Clin. Chem. Lab. Med. 2008; 46:963-965. (Pubitemid 352000485)
10. Störmer M, Vollmer T, Henrich B, Kleesiek K, Drier J. Broad-range real-time PCR assay for the rapid identification of cell-line contaminants and clinically important mollicute species. Int. J. Med. Microbiol. 2009; 299:291-300.
11. 〈1223〉 Validation of Alternative Microbiological Methods. In: United States Pharmacopeia. 34th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 2011.
12. 5.1.6. Alternative Methods for Control of Microbiological Quality. In: European Pharmacopoeia. 7th ed. Strasbourg, FR: European Directorate for the Quality of Medicines; 2011.
13. 2.6.27 Microbiological Control of Cellular Products. In: European Pharmacopoeia. 7th ed. Strasbourg, FR: European Directorate for the Quality of Medicines; 2011.
14. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products; 2008.
15. Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA J. Pharm. Sci. Technol. 2000; 54:23.
16. Drier J, Vollmer T, Kleesiek K. Novel Flow Cytometry-Based Screening for Bacterial Contamination of Donor Platelet Preparations Compared with Other Rapid Screening Methods. Clin. Chem. 2009; 55:1492-1502.
17. General Notices. In: Japanese Pharmacopoeia. 15th ed. Tokyo, JP: Ministry of Health, Labour and Welfare; 2006.
18. 〈1225〉 Validation of Compendial Procedures. In: United States Pharmacopeia. 32nd ed. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 2009.
19. Chambers D, Kelly G, Limentani G, et al. Analytical Method Equivalency: An Acceptable Analytical Practice. Pharm. Technol. 2005; 29:64-80. (Pubitemid 41285903)