Ensuring Sterility of Parenteral Products - Pharmaceutical Technology

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PharmTech Europe

Ensuring Sterility of Parenteral Products
Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 37, Issue 4, pp. 62-67

References

1. The Local, “Dirty bottle likely source of bacteria in Mainz infant deaths,” Press Release, Aug. 27, 2010.

2. CBS News, “Lethal medicine linked to meningitis outbreak,” Press Release, Mar. 10, 2013.

3. R.P. Vonberg and P. Gastmeier: J. Hosp. Infect., 65 (1) 15-23 (2007).

4. C.M. Clothier, Clothier Report, Report of the Committee appointed to inquire into the circumstances, including the production, which led to the use of contaminated fluids in the Devonport section of Plymouth General Hospital, London: Her Majesty’s Stationery Office, 1972.

5. M.A. Kainer et al, N Engl J Med., 367 (23) 2194-2203 (2012).

6. B. Cox, A Lesson on Outsourcing: The NECC Fungal Meningitis Outbreak, The Gold Sheet, 46 (11) 1-6 (2012).

7. J.S. Eglovitch, Lack of Microbiological Controls Have Grave Consequences for Compounders, The Gold Sheet, 46 (11) 16-18 (2012).

8. B. Verjans and C. Reed, Biopharm. Intl., 25 (3) 46-58 (2012).

9. S.V.W. Sutton, J of GXP Compliance, 16 (4) 59-63 (2012).

10. D. Niccum and P. Hairston in Environmental Monitoring: A Comprehensive Handbook, Volume 6, Jeanne Moldenhauer, Ed. (PDA, Bethesda, MD 20814, 2012), pp. 219-240.


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