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

Latest Issue

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


1. T. Sandle and M. Saghee, Jrnl of Comm. Biotechnol. (2011).

2. G. Rao, A. Moreira, and K. Brorso, Biotechnology and Bioengineering 102 (2) 348–356 (2008).

3. Radiation Sterilization Working Group (AAMI Sterilization Standards Committee). Radiation Sterilization—Material Qualification. Technical Information Report No. 17–1997. Association for the Advancement of Medical Instrumentation (Arlington, VA, 1998).

4. W. Wozniak-Parnowska and A. Najer, Acta Microbiol. Pol. 27 161–168 (1978).

5. W.A. Rutala, M.F. Gergen, and D.J. Weber, American Jour. of Infection Control 26 (4) 393-398 (1998).

6. A.G. Chmielewskia, M. Haji-Saeida, and S. Ahmedb, "Progress In Radiation Processing Of Polymer," Nuclear Instruments and Methods in Physics Research 236 (1-4) 44-54 (2005).

7. S. Baloda, BioProcess Inter. Supplement 10-22 (May 2008).

8. K.J.R. Clark and J. Furey, BioProcess Inter. 4 (6) S16-S20 (2006).

9. H. Pora, and B. Rawlings, BioProcess Int. 7 (14): 9-16 (2009).

10. M.A. Sebold, and J.A. Williams, "Radiation Sterilization" in M.R. Saghee, T. Sandle, and E.C. Tidswell (Eds.), Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Business Horizons, 841-872 (New Delhi, 2011).

11. E. Zandbergen and M. Monge, BioProcess Inter. Supplement 48-51 (June 2006).

12. R. Tykva and D. Berg, Man-Made and Natural Radioactivity in Environmental Pollution and Radiochronology, Kluwer Academic Publishers (Amsterdam, 2004).

13. E.R.L. Gaughran, and R.F. Morrissey, Sterilization of Medical Products, Volume 2, Multiscience 35-39, (Montréal, 1981).

14. A. Booth, Sterilization of Medical Devices, Buffalo Grove: Interpharm Press, 1998.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here