Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements.


Pharmaceutical Technology
Volume 36, Issue 5, pp. s20-s30

15. P. P. Dendy and B. Heaton, Physics for Diagnostic Radiology, CRC Press. p. 12. (1999).

16. P. Whaid, An Introduction to Isotopes and Radiations, Allied Publishers Limited, (Mumbai, 2001).

17. A. Vértes, S. Nagy, and Z. Klencsár, Handbook of Nuclear Chemistry, Volume 3. Kluwer Academic Publishers (Amsterdam, 2003).

18. ANSI/AAMI/ISO 11137-1: 2006. Sterilization of health care products-Radiation–Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

19. N.A. Halls, Achieving Sterility in Medical and Pharmaceutical Products, Marcel Dekker (New York, 1994).

20. N. Martakis, M. Niaounakis, and D. Pissimissis, Journal of Applied Polymer Science 51 (2) 313–328 (2003).

21. A. Tallentire, Radiat. Phys. Chem. 15 83–89 (1980).

22. Majewski, S., Bowen, M., Zorn, C., et al., "Radiation Damage Studies In Plastic Scintillators With a 2.5-MeV Electron Beam," Nuclear Instruments and Methods in Physics Research 281 (3) 500-507 (1989).

23. ISO, Sterilization of Medical Devices–Microbiological Methods–Part 1: Estimation of Population of Microorganisms on Products, ISO 11737-1: 1995, ISO (Geneva, 1995).

24. A. Anellis, D. Berkowitz, and D. Kemper, Appl Microbiol. 25(4) 517–523, (1973).

25. T. Sandle, "Practical Approaches to Sterility Testing" in M.R. Saghee, T. Sandle, and E.C. Tidswell, (Eds.), Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Business Horizons, 173192 (New Delhi, 2011).

26. ISO, Sterilization of Medical Devices–Microbiological Methods–Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process, ISO 11737-2: 1998, ISO (Geneva, 1998).

27. J-M Cappia and N.B. T. Holman, BioProcess Inter. 2 (9) 56-63 (2004).

28. J.A. Beck, International Journal of Radiation Applications and Instrumentation, Part C. Radiation Physics and Chemistry 35 Issues 4-6, 811-815 (1990).

29. ISO, Quality Management Systems–Requirements, ISO 9001: 2000, ISO, (Geneva, 2005).

30. Genova, Hollis, Crowell and Schady, Journal of Parenteral Science and Technology 41 (1) 33-36 (January 1987).

31. D. Jenke, Journal of Pharmaceutical Science and Technology 64 (6) 527-535 (2010).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here