A Preliminary Investigation into the Ability of Three Rapid Microbiological Methods To Detect Microorganisms in Hospital Intravenous Pharmaceuticals

References

1. 1.↵
   Medicines and Healthcare Products Regulatory Agency (MHRA). Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Her Majesty's Stationery Office (HMSO): London, 2007.
2. 2.↵
   The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 1 Manufacture of Sterile Medicinal Products. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Accessed November 17, 2010.
3. 3.↵
   1. Beaney A. M.

   The Quality Assurance of Aseptic Preparation Services. 4th ed.; Beaney A. M. Ed.; NHS Quality Control Committee: London, 2006.
4. 4.↵
   1. Farwell J.

   Aseptic dispensing for NHS patients [Farwell report]. Department of Health: London, 1995.
5. 5.↵
   1. Frean J.,
   2. Arntzen L.,
   3. Rosekilly I.,
   4. Isaäcson M.

   Investigation of contaminated parenteral nutrition fluids associated with an outbreak of S. odorifera septicaemia. J. Hosp. Infect. 1994, 27 (4), 263–273.

   OpenUrlCrossRefPubMedWeb of Science
6. 6.↵
   Investigation exonerates staff of babies' deaths in German clinic. www.dw-world.de/dw/article/0,,5950725,00.html. Accessed November 3, 2010.
7. 7.↵
   1. Miller M. J.

   The implementation of rapid microbiological methods. European Pharmaceutical Review 2010, 15 (6), 27–31.

   OpenUrl
8. 8.↵
   1. Riley B. S.

   A regulators view of Rapid Microbiology methods. European Pharmaceutical Review 2011, 16 (5), 3–5.

   OpenUrl
9. 9.↵
   1. Baumstummler A.,
   2. Chollet R.,
   3. Meder H.,
   4. Rofel C.,
   5. Venchiarutti A.,
   6. Ribault S.

   Detection of microbial contaminants in mammalian cell cultures using a new fluorescence-based staining method. Lett. Appl. Microbiol. 2010, 51 (6), 671–677.

   OpenUrlPubMed
10. 10.↵
    1. Bussey D. M.,
    2. Tsuji K.

    Bioluminescence for USP sterility testing of pharmaceutical suspension products. Appl. Environ. Microbiol. 1986, 51 (2), 349–355.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Parveen S.,
    2. Kaur S.,
    3. David S. A.,
    4. Kenney J. L.,
    5. McCormick W. M.,
    6. Gupta R. K.

    Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products. Vaccine 2011, 29 (45), 8012–8023.

    OpenUrlPubMed
12. 12.↵
    1. Kielpinski G.,
    2. Prinzi S.,
    3. Duguid J.,
    4. du Moulin G.

    Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel®, autologous cultured chondrocytes. Cytotherapy 2005, 7 (6), 531–541.

    OpenUrlCrossRefPubMed
13. 13.↵
    SC IV L. Alternative methods for control of microbiological quality. In European Pharmacopoeia; HMSO: London, 2010.
14. 14.↵
    Appendix XVI E. Microbiological Control of Cellular Products. In British Pharmacopoeia; HMSO: London, 2010.
15. 15.↵
    General Information Chapter <1223> Validation of Alternative Microbiological Methods. In USP 32-NF27; US Pharmacopeial Convention: Rockville, MD, 2009.
16. 16.↵
    Appendix XVI B: Microbiological Examination of Non-Sterile Products. In British Pharmacopoeia; HMSO: London, 2010.
17. 17.↵
    European Standard EN1040. Chemical Disinfectants and Antiseptics—Basic Bactericidal Activity—Test Method and Requirements (Phase 1); European Committee for Standardization: Brussels, 1997.
18. 18.↵
    European Standard EN14347. Chemical Disinfectants and Antiseptics – Basic Sporicidal Activity – Test Method and Requirements (Phase 1, Step 1); European Committee for Standardization: Brussels, 2005.
19. 19.↵
    1. Miles A. A.,
    2. Misra S. S.,
    3. Irwin J. O.

    The estimation of the bactericidal power of the blood. J. Hygiene 1938, 38 (6), 732–749.

    OpenUrlCrossRef
20. 20.↵
    1. Hiom S.,
    2. Sa A.,
    3. Guerrin C.,
    4. Maillard J.,
    5. Williams G.,
    6. Spark P.,
    7. Smith J.,
    8. Girdlestone S.,
    9. Denyer S.

    Investigation into rapid microbial detection methods (RMM) to improve the QA of NHS manufactured aseptic products. Int. J. Phar. Pract. 2010, 18 (Suppl 2), 92.

    OpenUrl
21. 21.↵
    1. Miller M. J.

    Rapid microbiological methods and demonstrating a return on investment: It's easier than you think. Am. Pharm. Rev. 2009, 12 (5), 42–47.

    OpenUrl
22. 22.↵
    1. Gadal P.,
    2. Yvon P.

    Rapid microbio ROI—calculating scientific benefits as return on investment dollars. Pharmaceutical Formulation & Quality 2009, 11 (3), 44–47.

    OpenUrl
23. 23.↵
    UK Department of Health. Modernising the NHS hospital medicines manufacturing service. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4003015. Accessed May 4, 2010.
24. 24.↵
    1. Jacklin A.

    First chemotherapy robot in use in UK hospital. British Journal of Clinical Pharmacy 1 2009, February, 39–40.
25. 25.↵
    UK Department of Health and Social Security (DHSS). Report of the Working Party on the Addition of Drugs to Intravenous Infusion Fluids; DHSS: London, 1976. Health Circular (76) 9.
26. 26.↵
    UK Audit Commission Report. A Spoonful of Sugar: Medicines Management in NHS Hospitals; Audit Commission Publications: Wetherby, 2001.
27. 27.↵
    UK NHS National Patient Safety Agency. Patient Safety Alert 20. Promoting Safer Use of Injectable Medicines; Patient Safety Alert 21. Safer Practice with Epidural Injections and Infusions; NPSA: London: 2007.
28. 28.↵
    Appendix XVI A. Test for Sterility. In British Pharmacopoeia; HMSO: London, 2010.
29. 29.↵
    1. Hiom SJ,
    2. Denyer S,
    3. Talbot C,
    4. Wilkes AR.

    Investigating rapid microbial detection methods as an alternative to total aerobic microbial counts for non-sterile bioburden assessments. EJPPS 2012; Volume 17, Issue 4: pp.138–141.

    OpenUrl