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Specialty Silicone Fabricators Adds Analytical Laboratory to Bolster Combination Product Services
Date:8/24/2011

TUSTIN, Calif., Aug. 24, 2011 /PRNewswire/ -- Specialty Silicone Fabricators (SSF) – Advanced Technologies announced today it has completed installation of various analytical equipment in support of its drug-device manufacturing services. The new equipment includes a Distek 2100C Dissolution System, Nicolet Thermo Scientific FTIR and an Agilent 1100 Series HPLC.  The lab, located at SSF – Advanced Technologies manufacturing plant in Tustin, Calif., will perform qualitative analysis such as identification of Active Pharmaceutical Ingredients (API) as well as quantitative analysis including purity determination, assay, content uniformity, elution rate profiling and stability testing.

"Adding analytical capabilities to our existing suite of manufacturing services makes us more dynamic and cost-effective," said Don Borje, president of SSF – Advanced Technologies. "We realize that drug homogeneity within a matrix is mission critical to our clients and we've invested heavily in mixing technologies to ensure that drug content is consistent component-to-component and batch-to-batch.  In-house analytical testing now allows us evaluate process capabilities and confirm API content within hours rather than weeks. This shortens the development cycle, saves times and reduces costs."

Since the launch of its combination product manufacturing services in 2009, SSF – Advanced Technologies has worked with both medical device and pharmaceutical companies in developing drug-device solutions for numerous healthcare disciplines including cardiology, ophthalmology, urology, women's health, wound management and orthopedics. Additionally the company is pursuing API-based antimicrobial platforms with broad utility across several sectors.

"The new equipment is already supporting client research and development projects and the goal is to be Current Good Manufacturing Practice (cGMP) compliant by the end of 2011," said Jaime Varela, QC laboratory manager, SSF – Advanced Technologies. "The test equipment will be used for analysis of API as well as matrix materials including silicone and bioresorbable thermoplastics."

About Specialty Silicone Fabricators

For over 25 years Specialty Silicone Fabricators (SSF) – Advanced Technologies has provided customized manufacturing solutions to the medical device industry. The company maintains three manufacturing sites in California and Michigan and currently employs nearly 250 dedicated individuals. SSF – Advanced Technologies is a recognized leader in all facets of silicone fabrication and medical device assembly. The company has been awarded six patents for its novel developments in silicone extrusion and thin film processing. Additional services include micromolding, coating expertise and device assembly as well as final package design and validation. The company also provides high tolerance thermoplastic extrusions. In 2009, SSF – Advanced Technologies received appropriate federal registration and state licensing to begin work with active pharmaceutical ingredients and today is at the forefront of the important drug-device combination product sector.


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