Gore PharmBIO: New Gaskets Can Reduce Risk of Contamination

Related tags Food and drug administration

Two new nonreactive product contact components can control contamination and meet regulatory requirements according to their makers, Gore PharmBIO.

Gore BioPharma (a wing of technology solutions company W.L. Gore), a company which manufactures a range of cleanroom products has launched two new gaskets - the Gore STA-PURE pipe gasket and the STA-PURE sheet gasket – which it claims can benefit pharmaceutical and biotechnology manufacturers.

Speaking with in-Pharmatechnologist.com, Liz Guiney, a spokeswoman from Gore PharmBIO, said “these gasketing products are developed for pharmaceutical and biopharmaceutical process piping applications that require reliable sealing products and compliance with specific regulatory criteria.”

The gaskets are made of ePTF (expanded polytetrafluoroethylene) which Guiney said is “a material that is recognized as chemically and mechanically resistant to highly aggressive process media” and are, to Gore’s knowledge, completely unique:

“No other company offers a 100-percent ePTFE gasket that meets the stringent requirements for lot traceability, sealing, and regulatory compliance for bolted metal and glass-lined flanges.”

Reliable long-term sealing in the cleanroom environment can be affected by factors including stress and creep and cold flow which can cause contamination and lead to manufacturers falling foul of regulatory requirements. Issues relating from disintegrated gasket material led to Genentech – now owned by Roche – receiving a 483 warning letter from the US FDA in 2011 at its Californian Avastin production plant.

“Pharmaceutical processing facilities often need to meet specific regulatory requirements,” said Guiney. “The new Gore STA-PURE gasketing products are manufactured and tested under stringent quality systems and relevant GMPs to meet those requirements.”

The STA-PURE pipe gasket is aimed at standardizing gasket materials across steel, glass-lined steel and Fiberglass Reinforced Plastic (FRP) systems whilst the STA-PURE sheet gasketing system is chemically inert and stable at high temperatures and pressures, and is made as a sealant for irregular and coarse flanges.

Guiney also added that “these products also include documented lot traceability, which is important for managing the supply chain.”