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Chapter-10 Radiation Sterilization

BOOK TITLE: Hospital Sterilization

Author
1. Nagaraja Prem Anand
ISBN
9789350250693
DOI
10.5005/jp/books/11249_10
Edition
1/e
Publishing Year
2011
Pages
8
Author Affiliations
1. Bengaluru, Karnataka, India
Chapter keywords

Abstract

Radiation sterilization appeared in the United States Pharmacopeia in 1965 and since then, the US Food and Drug Administration has regarded a radiation-sterilized drug as a new product. In the United Kingdom, sterilization by ionizing radiation has been a recognized method since 1980, when the Ministry of Health agreed to accept materials exposed to a radiation dose of 25 kGy. The Regulatory Agency’s Committee on Safety of Medicines requires proof of sterility. They also look for proof that the drug’s potency is unaffected by the process and that degradation products arising from the radiation process are not harmful. Although the British Pharmacopoeia recognizes gamma irradiation as a suitable sterilization process, the manufacturer must prove that no product degradation has taken place. Most European countries allow pharmaceuticals to be radiation sterilized, provided that authorization has been obtained from the appropriate health authorities. Drug makers have been using gamma irradiation to sterilize pharmaceutical products for more than 40 years. High-energy gamma irradiation is used mainly in the health care industries to sterilize disposable medical devices. However, over the years, the number of radiation-sterilized pharmaceuticals has increased. Pharmaceutical companies now sterilize drugs such as ophthalmic preparations, topical ointments, veterinary products, and parenterals by using radiation. One main factor that has promoted radiation sterilization is the regulatory pressure to adopt terminal-sterilization processes.

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