Abstract
This paper will outline the advantages of utilizing gamma radiation as a means for terminally sterilizing parenterals and other pharmaceutical products. The factors which must be evaluated in order to qualify a product for radiation sterilization will be detailed. It will also compare the characteristics of this method with other technologies currently available. The highest SAL can be achieved by combining a knowledge of the microbial quality of the raw materials, and the manufacturing environment with a formulation designed to promote the most radiation stable form of the product.
- Received January 28, 1994.
- Accepted September 19, 1994.
- Copyright © Parenteral Drug Association. All rights reserved.
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