When it comes to drug delivery, NuSil provides numerous solutions that fit a variety of device needs for transdermal, transmucosal, both long-term and short-term implanted devices, intrathecal and external delivery devices. Backed by years of pharmaceutical materials expertise and first-hand regulatory knowledge - NuSil’s comprehensive Drug Delivery Silicone (DDS) line of materials and services are intentionally designed for drug delivery and combination medical device products.
Drug Master Access Files that consist of extensive physical, chemical and biological testing – as well as testing guided by applicable European Pharmacopeia Monographs – are available. Additional features include customized, certified per-lot testing, including select tests guided by ISO 14949. Unique lot numbers may also be assigned to each uncured silicone part to ensure that identification standards within the pharmaceutical industry are met.
Regardless of batch size, you can count on NuSil to deliver high-quality silicone materials based on your unique property requirements, as well as provide precise, custom formulations. NuSil will incorporate APIs directly into silicones specifically developed for controlled release in our production-scale manufacturing site that has been registered with US FDA and ISO 9001 certified since 1994.
What? Where? When? If it's NuSil, it's no problem.