Carpinteria, California, USA
14 April 2010
API compounded into silicones
NuSil Technology opened a new clean room manufacturing facility on 14 April 2010. Located in Carpinteria, California, close to the company’s headquarters in the US, the facility will offer contract manufacturing and silicone compounding services to companies in the pharmaceutical and biotech industries. It has been certified by the FDA as well as the California State Health Department.
The facility was launched as a result of the industry’s burgeoning demand for a silicone manufacturer that can compound active pharmaceutical ingredients (APIs) into silicones. API compounding was earlier carried out at the Bakersfield facility of NuSil Technology. However in 2004, with the installation of an expanded simethicone line, the focus of the facility was diverted towards simethicone production. This created the need for a new clean room, the construction of which began in California in August 2009.
NuSil Technology operates three manufacturing sites in Bakersfield, California and Irving. Together the sites occupy more than 250,000ft² of research and manufacturing capabilities.
The California facility was expanded in 2003 with new offices, laboratories, mixing and packaging areas in addition to a white room to conduct clean room-type manufacturing. In Texas, NuSil Technology also operates a state-of-the-art manufacturing and warehousing facility that extends 90,000ft².
NuSil clean room manufacturing facility
The new facility spreads over 2,400ft² and accommodates multiple clean room suites. The clean room suites are environmentally controlled up to Class 10,000. Initially, until the end of March 2010, the clean rooms were classified up to Class 100,000. Slight modifications by the end of April 2010 gradually upgraded the clean rooms to Class 10,000 standards. The facility is fully installed with state-of-the-art equipment.
Clean room facility production
The new clean room facility will be allocated to produce active pharmaceutical ingredients (API), including silicones. A range of silicones will be compounded directly with the APIs at quantities ranging from 50ml kits to 55 gallon drums. Silicones, unlike element silicone, are inorganic polymer excipients. Silicone does not contain any carbon atoms in its backbone and can be combined with APIs to improve drug delivery.
NuSil’s line of drug delivery solutions includes fluids and greases, adhesives, gels, high-consistency elastomers and liquid silicone rubber (LSR) elastomers. Meant specifically for drug delivery and combination medical device products, the silicones are categorised into unrestricted and restricted drug delivery silicones. Unrestricted drug delivery silicones are meant specifically for long-term implant applications, usually more than 30 days. For short-term implant applications, which last less than 29 days, the restricted drug delivery silicones are considered.
Two new transdermal adhesives were added to NuSil’s range of drug delivery silicones (DDS) on 8 April 2010, a few days after the facility was completed. The first silicone, designated as DDR-1370, is a one-component pressure sensitive adhesive that forms a bond when pressure is put to stick the adhesive with the adherend. It is designed to offer greater cohesive strength and a better release force, which gives optimum temporary adhesive properties to the material.
The second adhesive, titled DDR-4355, is a see-through soft silicone gel. The gel has a high surface-track temporary silicone adhesive. Coating processes can be used for applying both the adhesives. However, when choosing a temporary, transdermal adhesive, these two adhesives represent two different alternatives.
Other silicone products within NuSil Technology’s portfolio include a transparent silicone fluid DDU-310 that has controlled volatility, low surface tension and lubricating characteristics. In addition, there is a pressure-sensitive adhesive, a pourable silicone gel, a soft, two-component silicone elastomer with a high tear strength, a pourable three-part silicone elastomer and a pourable two-part silicone elastomer.
All the drug delivery silicones of NuSil Technology can be customised to contain the release of a broad range of APIs during particular applications.