BioPure has developed a range of high-purity, platinum-cured silicone gaskets and braided hoses, adding to its extensive range of fluid path components.
This technology is designed to meet the requirements of biotechnology and pharmaceutical single-use applications, enabling users to simplify and expedite validation procedures.
Silicone gaskets
BioPure high-purity, platinum-cured silicone gaskets are designed for bioprocessing applications where fluid path connections are needed. Each is precision engineered to achieve a smooth bore, contamination-free fluid path under clamping compression. They are designed in accordance with American Society of Mechanical Engineers: Bioprocessing Equipment (ASME-BPE) standards and are ISO14644 Class 7 cleanroom manufactured and packed.
Senior product manager for fluid paths at Watson-Marlow Fluid Technology Group (WMFTG) Zoë Craik says: "This range of gaskets is a perfect example of our commitment to delivering complete fluid path technologies.
"When we engaged with customers at the design stage, they emphasised the need for solutions that simplify production operations, lower current good manufacturing practice (cGMP) manufacturing costs and reduce process validation. This is precisely what we have delivered. With laser-etched lot numbering on every part, these gaskets include post-sterilised validation to current United States Pharmacopeia (USP), European Patent (EP), and US Food and Drug Administration (FDA) standards, as well as extractable data is documented in line with BPOG guidelines."
The gaskets are available in ten size options from 0.5in to 8in unflanged, and in eight flanged size options from 1in to 8in. A perfect match with BioPure’s existing range of connectors and clamps, BioPure Platinum-cured silicone gaskets allow end users and original equipment manufacturers (OEM) to connect their single-use fluid paths with confidence.
Silicone braided hose
Also available is BioPure platinum-cured silicone braided hose. This is another precision-engineered product that further aligns the company’s biotechnology and pharmaceutical fluid path offer.
These single and double braided flexible hoses are designed for high-pressure applications. The hoses offer excellent bend radius, while a continuously extruded silicone bore assures the integrity of the contacting fluid. The new hoses are also able to withstand repeated autoclave and sterilisation processes.
BioPure platinum-cured silicone braided hose is manufactured and packed within an ISO14644 Class 7 cleanroom environment that gives users full batch traceability to raw material.
Similarly, hose is supported by industry leading validation and extractable data. A total of ten inner diameter sizes for single braided hose are available from 0.125in to 1in, while double braided hose comes in 0.5in, 0.75in and 1in internal diameters.