GAMMA PROCESSING TECHNOLOGY: AN …

GAMMA PROCESSING technology : AN ALTERNATIVE technology FOR. TERMINAL STERILIZATION OF PARENTERALS. BRIAN D. REID. 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 from of the product. Introduction This paper presents an overview of GAMMA Radiation PROCESSING for terminal sterilization as applicable to pharmaceutical products. It focuses on the unique capabilities of GAMMA radiation and how they may best be applied to pharmaceutical products. There is a growing need by, and pressure on, the pharmaceutical industry to find and use alternative terminal sterilization technologies.

being sterilized. This will facilitate bringing the material into the clean room manufacturing area. Bioburden It is particularly important to know …

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  Technology, Processing, Gamma processing technology, Gamma, Sterilized

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