FDA Compliant Seals for Sterile Filling of Pharmaceuticals

A German-based contract manufacturer uses GYLON BIO-PRO® and GYLON BIO-ASEPT® for aseptic and sterile production in glass ampoules from 1 to 30 ml and glass vials from 5 ml to 500 ml.

As a contract manufacturer of pharmaceuticals, the highest productivity of the equipment is always in the foreground, while at the same time placing high demands on safety, durability and conformity (FDA, EC1935/2004 and USP). A company with more than 40 years of experience in the industry sought to significantly increase the service life of its equipment seals. The manufacturer’s core competence is the sterile filling of water for injection, electrolyte solutions, vitamin solutions, painkillers, herbal medicines and homeopathic preparations, sterile drugs and other pharmaceuticals in glass ampoules and vials. Investigations and joint discussions with Garlock revealed that GYLON BIO-PRO® (Style 3504) according to DIN 11850 and DIN EN 10357 and additionally GYLON BIO-ASEPT® (Style 3504) according to DIN 11864 and DIN 11853 were the best solutions. Due to the better properties of GYLON BIO-PRO® in its behaviour to load and temperature changes, the customer was able to extend the lifetime up to four times. GYLON BIO-PRO® also ensures conformity to FDA, EC1935 and USP. In addition the effectiveness of the Garlock solutions also convinced the OEM manufacturer to use other products from the GYLON BIO-LINE®.

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Garlock is a multinational manufacturer of high-performance fluid sealing and pipeline solutions with an emphasis on safety, longevity, and productivity. We work in partnership with our customers, industry associations, and governmental entities to understand their unique sealing challenges and respond with innovative solutions that keep people safe ...