Gamma Irradiation in the Pharmaceutical Manufacturing Environment - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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,
.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here