Transcription of GAMMA PROCESSING TECHNOLOGY: AN …
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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.
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
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Regulatory Affairs, Qsite, Radiation sterilization validation, Sterilization, Radiation, VALIDATION, STERILIZATION VALIDATION, STERILIZATION VALIDATION RADIATION STERILIZATION VALIDATION, Aseptic Area Validations STERILIZATION, STERILIZATION EQUIPMENTS Aseptic Area Validations, Ethylene Oxide (EO/EtO) Sterilization, Effect of common sterilization techniques on, Du Pont, California Code of Regulations Division, MANUFACTURING PRACTICE GUIDELINE, MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS