Live from MD&M West: NuSil Offers Raw Material Regulatory Support

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NuSil has launched a line of silicone materials for drug-delivery applications.

Silicone compound supplier NuSil Technology (Carpinteria, CA) now offers regulatory support for its implantable drug-delivery silicone materials. Responding to customer requests for drug master files and per-lot testing, the company is offering regulatory support services for its DDU-4340 liquid-silicone rubber, and DDU-4630 high-consistency rubber, and DDU-310, a clear polydimethylsiloxane liquid.

Using material pedigrees that demonstrate raw material regulatory compliance can help device manufacturers meet the requirements associated with critical drug-delivery and long-term implantable applications. In addition to drug master files that are submitted to FDA, the company can provide documentation for USP Class VI and ISO 10993 testing support and testing guided by European Pharmacopeia Monograph 3.1.9. The company's per-lot testing services include select ISO 14949 testing, including hexane reflux extraction, as well as FT-IR spectroscopy. It also can provide tissue culture or cytotoxicity testing and select toxicity testing services. Additionally, unique lot numbers are assigned to each uncured part.