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February 2020


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Daniel Morris <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 6 Feb 2020 12:40:51 +0000
text/plain (37 lines)
Can you provide guidance for microbiological sample preparation and testing on  solid non-biodegradable extruded polymer passive drug delivery implants? Specifically, for pre-sterilization bioburden testing and sterility testing, is there an expectation to test just the outside surface of the implant, like one would for a medical device, or to test the "inside" of the implant since the polymer matrix elutes drug over time?
USP <1> implies that the implant may be dissolved but acknowledges that the solvents and conditions required to do this would be microbiocidal. ANSI/AAMI/ISO 11737-1 gives helpful guidance, but seems to deal only with the outside surfaces. There are a number of non-biodegradable polymer implants on the market used for contraceptive drug delivery; does anyone know how those are tested?

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