NuSil Technology Launches Specialized Drug Delivery Silicone Product Line
NuSil Technology, a cutting-edge manufacturer of silicone materials for the healthcare and pharmaceutical industries, has launched a comprehensive Drug Delivery Silicone (DDS) line of materials and services intended specifically for drug delivery and combination medical device products. For decades, NuSil Technology's extensive line of silicone fluids, elastomers and gels have been materials of choice for drug delivery and medical devices -- including matrix and reservoir-type delivery devices for transdermal, transmucousal, and long- and short-term implanted medical devices.
"At NuSil, we strive to meet the demands of the latest and most innovative drug delivery technologies by building upon our experience and expanding our products and services to offer one-of-a-kind support for our silicone materials," said Brian Nash, NuSil Technology's vice president of Marketing and Sales. "We are pleased to introduce this extended line of thoroughly tested medical materials and specialized services."
NuSil is well recognized for an unsurpassed level of regulatory support for its products, which includes extensive physical, chemical and biological testing in the form of Master Access Files (MAFs) submitted to the U.S. Food and Drug Administration (USFDA) for silicone materials intended for both short- and long-term implantable applications. NuSil has extended its level of regulatory support for the DDS materials by offering Drug Master Files (DMFs) that consist of extensive physical, chemical and biological testing - as well as testing guided by applicable European Pharmacopeia Monographs. 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.
Also, DDS materials can be customized for specific applications and uniquely tailored to influence the release of a wide range of Active Pharmaceutical Ingredients (APIs). On a large or small scale, NuSil has the manufacturing capacity and capability to incorporate APIs directly into silicones in its production-scale manufacturing site that has been registered with US FDA and ISO 9001:2000-certified since 1994.
For more information, visit www.nusil.com/drugdelivery.
About NuSil Technology
NuSil is a cutting-edge manufacturer of silicone compounds for healthcare, aerospace, electronics, photonics and other applications that require precise, predictable, cost-effective materials performance. NuSil has been providing silicone materials for long-term implantable applications for more than two decades. Many of NuSil's products meet Class VI and most ISO 10993 biological testing requirements, and many are supported by a comprehensive Master Access File (MAF) submitted to the FDA. NuSil operates ISO 9001:2000-certified state-of-the-art laboratories and processing facilities in North America and Europe and provides on-site, in-person application engineering support worldwide.
SOURCE: NuSil Technology