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The opportunities and challenges in future development of pharmaceutical products by HME technique are also discussed.Sterilization validation practices in the United States rely heavily on the destruction of microorganisms to establish that sufficient lethality has been delivered. The objective in many instances is demonstration of the poorly defined attainment of "overkill" throughout the load. The complete destruction of resistant spore formers is assumed to support the attainment of a minimum probability of a nonsterile unit (PNSU).
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