Gamma processing technology: an alternative technology for terminal sterilization of parenterals.
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.
Reid
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Nordion International, Inc., Kanata, Ontario, Canada.
D005720:Gamma Rays; D004364:Pharmaceutical Preparations / Q000592:standards*; D013242:Sterilization
D004364:Pharmaceutical Preparations