Radiation Sterilization of Parenterals - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Radiation Sterilization of Parenterals
Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.


Pharmaceutical Technology


4. Association of the British Pharmaceutical Industry, Use of Gamma Radiation Sources for the Sterilization of Pharmaceutical Products, (ABPI, London, 1960).

5. P.J. Geue, Radiosterilization of Pharmaceuticals, A Bibliography, 1962-1972, (Australian Atomic Energy Commission, Lucas Heights, Australia, 1973).

6. N.G.S. Gopal, "Radiation Sterilization of Pharmaceuticals and Polymers," Radiat. Phys. Chem. 12 (1), 35–50 (1978).

7. G.P. Jacobs, "A Review: Radiation Sterilization of Pharmaceuticals," Radiat. Phys.Chem. 26 (2), 133–142 (1985).

8. G.P. Jacobs, "A Review of the Effects of Gamma Radiation on Pharmaceutical Materials," J. Biomat. 10 (1), 59–96 (1995).

9. G.O. Phillips, "Medicines and Pharmaceutical Base Materials," in Manual on Radiation Sterilization of Medical and Biological Materials, (International Atomic Energy Agency, Vienna, 1973), pp. 207–228.

10. R. Schnell and W. Bogl, "Teil VI and VII, Bericht des Instituts fur Strahlenhygiene des Bundesgesundheitsamtes," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1984).

11. C. Schuttler, W. Bogl, and K. Stockhausen, "Teil II and III," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1979).

12. C. Schuttler and W. Bogl, "Teil IV and V," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1982).

13. H.Trutnau, W. Bog, and K. Stockhausen, "Teil I," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1978).

14. Ch. Zalewski, C. Schuttler, and W. Bogl, "Teil VIII," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1988).

15. C. Boess and W. Bogl, "Influence of Radiation Treatment on Pharmaceuticals—A Review: Alkaloids, Morphine Derivatives, and Antibiotics," Drug Dev. Ind. Pharm. 22 (6), 495–529 (1996).

16. P.A Wills, "Effects of Ionizing Radiation on Pharmaceuticals," Aust. J.Pharm. 44 (supp. 5), 550–557 (1963).

17. T.A. DuPlessis, The Radiation Sterilization of Pyrogen-Free Water in Polyethylene Sachets, (Atomic Energy Board, Pretoria, South Africa, Report PER-17-1, 1977).

18. N. Hilmy and S. Sadjirun, "Polyethylene Plastics as Containers for Water for Injection and as Material for Disposable Medical Devices Sterilized by Radiation," in Radiosterilization of Medical Products 1974 (International Atomic Energy Agency, Vienna, 1975), pp. 145–157.

19. G.P. Jacobs et al., "The Use of Gamma-Irradiation for the Sterilization of Water for Injections and Normal Saline Solution for Injection," Acta Pharma. Suec. 14 (3), 287–292 (1977).

20. G.P. Jacobs and E. Eisenberg, "The Reconstitution of Powders for Injection with Gamma-Irradiated Water," Intl. J. Appl. Radiat. Isotopes 32 (3), 180–181 (1981).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here