Gamma Irradiation in the Pharmaceutical Manufacturing Environment - Pharmaceutical Technology

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Gamma Irradiation in the Pharmaceutical Manufacturing Environment
The author reviews the benefits, challenges, and considerations to be made when selecting a gamma-irradiation sterilization method.


Pharmaceutical Technology
Volume 34, pp. s40-s43

Conclusion

No single idea will solve all the potential challenges related to sterilization. A combination of tests are required for optimum results. This article, therefore, cannot address all the possible options to consider when selecting a sterilization method, but it does aim to demonstrate that making minor changes early in the development process can enable terminal irradiation. Terminal sterilization can have many benefits as long as one considers the critical factors to the product's success and usability. These factors may include the cost and time to manufacture a finished product, available facilities and equipment to make and sterilize the product with the chosen method, stability, safety, efficacy, potency, costs, regulatory requirements, and even customer expectations. Each factor must be considered to successfully select a sterilization process.

Sources

1. AAMI/ISO 11137:2006 Sterilization of Healthcare Products—Radiation, Part 1 2 and 3.

2. AAMI TIR 33:2005 Sterilization of HealthCare Products—Radiation-Substantiation of a Selected Sterilization Dose-Method VDmax.

3. AAMI TIR 40:2009 Sterilization of Healthcare Products-Radiation-Guidance on Dose Setting Using a Modified Method 2 .

4. AAMI TIR 17:2008 Compatibility of Materials Subject to Sterilization.

5. K.J. Hemmerich, "Polymer Materials Selection for Radiation Sterilized Products," Medical Device and Diagnostic Industry, Feb. 2000.

6. R. Garcia et al., Pharm. and Med. Packag. News (May 2004).

7. J. Masefield and R. Brinston, Medical Device Technology, 18 (2), March/April 2007.

8. V. Reitz, "The Best of All Worlds," Medical Design, pp. 42–45 (Sept. 2006).

9. K. Latta et al., International Jrnl. of Pharma. Compound., 13 (2), March/ April 2009

10. International Atomic Energy Agency, Technical Reports Series No. 149, Manual on Radiation of Medical and Biological Materials, 1973.

Betty Howard is the Radiation TechTeam Manager for STERIS Isomedix Services, Radiation Technology Center at Steris, 7828 Nagle Ave., Morton Grove, IL 60053, tel. 847.966.1160,
.


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