NuSil Technology opened a clean room manufacturing facility in Carpinteria, California on April 14, 2010. The facility is located in Carpinteria in California, near the company’s headquarters. It will provide contract manufacturing and silicone compounding services for companies in the biotech and pharmaceutical industries. It has been approved by both the FDA and the California State Health Department.
This facility was created in response to the growing demand from the industry for silicone manufacturers that can make active pharmaceutical ingredients (APIs). API compounding was previously done at NuSil Technology’s Bakersfield facility. In 2004, however, simethicone production was the main focus of the facility. The need for a clean room was created. Construction began in California in August 2009.
NuSil Clean-Room Manufacturing Facility
The facility covers 2,400 ft2 and has multiple clean-room suites technology diffusion. Clean room suites can be controlled to an environmental Class 10,000. The clean rooms were initially classified as Class 100,000 until March 2010. The clean rooms were gradually elevated to Class 10,000 standards with minor modifications at the end of April 2010. This facility has been fully equipped with the most modern equipment.
In 2003, the California facility was expanded with new offices and laboratories. There are also mixing and packaging areas. A white room is available for clean-room manufacturing. NuSil Technology in Texas also has a state of the art manufacturing and warehousing plant that spans 90,000.ft2.
Production of Clean Room Facilities
The clean room will be used to make active pharmaceutical ingredients (API), such as silicones. The APIs can be combined with a variety of silicones in quantities from 50ml bottles to 55-gallon drums. Inorganic polymer excipients are available for silicones. Silicone is free of carbon atoms and can be mixed with APIs for improved drug delivery.
NuSil’s drug delivery solutions include fluids and greases as well as adhesives, gels and high-consistency silicone elastomers. The silicones are designed for drug delivery and combination products and can be classified into restricted and unrestricted drug delivery silicones. The unrestricted drug-delivery silicones are intended for long-term implants applications that last more than 30 days. The restricted drug delivery silicones can be used for short-term implant applications that last less than 29 day.
NuSil Technology also offers DDU-310, a transparent silicone liquid with low surface tension, controlled volatility and lubricating properties. There is also a pressure sensitive adhesive, a pourable silicone gel, and a soft, two component silicone elastomer that has a high tear strength.
NuSil Technology’s drug delivery silicones can be customized to allow for the release of specific APIs.
