Now ISO 13485:2003 Certified
Foamtec International LLC, WCC division announces that it has become certified to ISO 13485:2003, compliant with International FDA standards for the manufacture of medical devices. The scope of supply is sterile and non-sterile applicators, swabs, wipers, pads, foam and foam component assemblies, and plastics and plastic assemblies. Bureau Veritas issued the certificate on November 17, 2008.
“Foamtec International is the leading innovator in engineering tools to clean critical surfaces”, said Michael Strauss, Director of Business Development at Foamtec International WCC. “With our recent success in becoming certified to ISO 13485, we can bring our outstanding quality and engineering capabilities to the Medical, Pharmaceutical, Biotechnology and Medical Device industries. Our non-toxic, entotoxin-free foam products make a novel drug delivery system. Coupled with our state-of the-art cleanroom manufacturing facilities and the ability to provide gamma-irradiated sterile applicators, Foamtec International is well positioned to create differentiated drug delivery systems.”
Key customers recognize the value of having suppliers that dedicate the time and resources necessary to achieve ISO 13485 certification. "Having Foamtec International as a strategic partner that is ISO 13485 certified has an immense value,” said Susan Spillane, Director of Product Development for Sonic Packaging, a contract packaging company serving the Life Science industries. “Production under this globally recognized quality management system is required by all of our regulated industries customers. Items made by Foamtec International are manufactured under the same high quality standards that all regulated industries companies comply with. Working with Foamtec to provide unique, value-added drug delivery devices is critical in meeting Pharmaceutical, Bio-Tech and Medical Device customer needs.”
Foamtec International is the leading manufacturer of technical urethane foam products, serving the specialty foam needs of the consumer, clean room, microelectronic, and life science markets. Foamtec is fully integrated to fabricate critical sub-assemblies and finished tools. With almost 100 years expertise and experience in formulating unique technical foam products, Foamtec designs and engineers unique pharmaceutical product delivery systems and other tools to solve difficult cleaning problems in critical manufacturing environments.
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