The expanded product range offers tailor-made solutions for customers with specific bioprocessing requirements.
Watson-Marlow Fluid Technology Group (WMFTG) announces the expansion of its puresu® single-use range, providing a combination of components that are safe and easy-to-install. Puresu is ideal for the end-to-end manufacture of biopharmaceuticals and personalised medicines, such as gene therapies. The expanded range consists of three new product options: sterile claim, gamma irradiated and non-irradiated.
WMFTG’s puresu assemblies offer a unique solution to the challenges of bioprocessing, providing controlled, efficient and reliable single-use assemblies that simplify validation processes. Offering open architecture design, by using the single-use components customers can quickly create a sterile fluid path that meets their specific bioprocessing needs.
With the addition of sterile puresu WMFTG now offers three product variants which each offer distinct benefits. Sterile puresu is an optimal solution for critical fluid path bioprocesses and customers who require contamination risk mitigation. Gamma irradiated puresu is suitable for customers who manage microbial control through bioburden reduction. Non-irradiated puresu is ideal for process development activities. WMFTG offers support on the products supplied to ensure a safe, flexible and quick delivery.
The puresu® single-use assemblies offer:
- Three product options: non-gamma irradiated, gamma irradiated (25kGy – 45kGy) or sterile claim (10-6 SAL)
- Assemblies are available with a sterility assurance level (SAL) claim of 10-6 SAL with a two-year shelf life, validated in compliance with ANSI/ AAMI/ ISO 11137 VD max 25 methodology
- A range of fluid path components including Watson-Marlow Tubing products (Pumpsil®, PureWeld® XL BioPure Tubing, BioPure tubing fittings, Sanitary hose barbs, Bio-Clamps, valves and adaptors)
- USP 87 In Vitro (cytotoxity), USP 88 Class VI, ADCF, and complete product traceability
- Documented quality systems compliant with ISO 9001
Jim Sanford, Senior Product Manager, commented, “Our puresu customised assemblies offer a unique range of benefits to customers with different bioprocessing needs. We work with the customer to deliver a final design that is tailored to their individual requirements and specific applications. These new assemblies reinforce WMFTG’s reputation as a leading supplier of reliable and sterile tubing products for use in biopharmaceutical manufacturing.”