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Contract Sterilization and Validation Companies Offer New Options for Sterile Compounded Preparations

Author(s):  Latta Kenneth S, Howard Betty, Gordon Ken, Foster Lisa, Nichols Larry, Floyd Dan B, Winters Martell, Bryans Trabue

Issue:  Mar/Apr 2009 - Sterile Compounding
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Abstract:  To ensure patient safety, adhere to good compounding practices, and safeguard against professional liability, the sterility of some compounded preparations must be assured. When in-house sterilization capabilities do not suffice, the intervention of a contract sterilization and/or validation company can assist in establishing the sterility, purity, and potency of the pharmaceuticals used in compounded preparations. In this article, three contract sterilization companies and two contract validation firms are profiled, methods that compounders can use to best interface with those companies are presented, and sterilization and validation processes are explained and compared.


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