Case Study: Pharmaceutical Gel Capsules GYLON BIO-PRO®

The customer’s USA facility was using both EPDM and PTFE sanitary gaskets throughout their process, but they had encountered issues over the years with both materials. The EPDM gaskets were typically over-tightened which created gasket intrusion and physical degradation, and upon replacement they were also found to be stuck to the ferrules, creating further problems when maintenance technicians had to use hard tools to scrape away any residue. The PTFE gaskets were easier to remove, but showed considerable evidence of creep and cold flow which created process leaks, resulting in build-up of crystallised gelatin around the tri-clamp connections. Worryingly, in both cases, there was evidence of downstream contamination from gasket fragments which frequently led to un-scheduled downtime, additional cleaning, as well as batch quarantine and disposal.