Sealing materials utilized in pharmaceutical joint connectors must be resistant to acids and alkalis during Cleaning In Place (CIP) and Sterilization in Place (SIP) cleaning processes, as well as withstand demanding temperatures and pressures. Elastomers typically fail to meet at least one of these requirements, and conventional PTFE proves unsuitable due to cold flow. The modified and restructured PTFE of the GYLON BIO-LINE® and BIO-LINE® PLUS series meet all of the above criteria and are performing well in service.
Below are two brief examples showing how GYLON BIO-PRO® and GYLON BIO-PRO® PLUS solved critical problems inherent in the process:
First, a manufacturer of Cytostatics for the treatment of oncological diseases have used these innovative solutions. Given the short service life of the seals used in the manufacturer’s tri-clamp connections, lasting about two weeks, and included conventional PTFE and PTFE-coated FKM seals. Due to the high creep and cold flow behavior of these materials, especially during the SIP cleaning process, the required service life was not met. Also, all connections had to be retightened after each cleaning process.
The aseptic production process for cytostatic injectables is subject to strict guidelines regarding the hygienic design of the systems. Good cleanability and sterilizability of all system components is essential. Garlock recommended the use of GYLON BIO-PRO® PLUS, made of the material GYLON® 3522. Due to its material properties, such as stopped cold flow and excellent dimensional stability, as well as having the full range of approvals for use in the pharmaceutical industry, GYLON BIO-PRO® PLUS exceeded the cytostatic manufacturer’s requirements. Retightening of the connections was no longer necessary. The GYLON BIO-PRO® PLUS seals only had to be replaced twice a year. The productivity of the plant was significantly increased.
The second study involves a sophisticated contract manufacturer of pharmaceuticals in glass ampoules and vials. The manufacturer’s process involved the sterile filling of water for injection, electrolyte solutions, vitamin preparations, analgesics, herbal and homeopathic preparations, narcotics and more. For a manufacturer of pharmaceuticals, it is critical to achieve the highest productivity of the equipment without compromising on safety, service life and conformities (FDA, EC1935/2004 and USP).
Through investigations and joint discussions with Garlock, GYLON BIO-PRO® to DIN 11850 and DIN EN 10357 and GYLON BIO-ASEPT® to DIN 11864 and DIN 11853 were found to be the best solutions – both made from GYLON® 3504. Due to the better properties of GYLON BIO-PRO® in terms of its behavior in relation to load and temperature changes, the customer was able to extend the service life of its product by up to four times. GYLON BIO-PRO® also ensures compliance with FDA (Food and Drug Administration), EC1935 (Regulation of the European Parliament on materials and articles intended to come into contact with foodstuffs) and USP (United States Pharmacopeia).