The growth of personalised medicines, such as cell and gene therapies, brings new challenges to the biopharmaceutical manufacturing sector. Watson-Marlow Fluid Technology Group (WMFTG) is introducing the ReNu SU cartridge assemblies with a 10-6 SAL claim to help satisfy this growing industry demand, providing a sterile single use pumping technology which is essential for the commercialisation of potentially life-changing medicines.
WMFTG has launched its new ReNu SU (single-use) Technology cartridge assemblies to aid the development and production of personalised medicines. The cartridge assemblies are for use with its Quantum peristaltic pump and offer a closed system for making sterile connections in non-sterile environments.
The ReNu SU Technology cartridge assemblies can be integrated directly into a customised fluid path, allowing for quick bioprocess integration whilst eliminating alignment errors. This reduces cost and lead time by simplifying the supply process. The closed system comprises an irradiated cartridge sealed at each end with a choice of three different types of aseptic connector, providing a simple, flexible assembly that can easily be installed into existing systems. With guaranteed sterility assurance, customers can use ReNu cartridges without needing to take further steps for any additional cleaning or validation. The ReNu SU Technology cartridge assemblies offer:
- Lot traceability on every component
- ISO Class 7 cleanroom manufactured and packaged assemblies
- Product Sterility of 10-6 SAL per ANSI/AAMI/ISO 11137 guidelines
- Range of standard aseptic connectors: CPC AseptiQuik, Pall Kleenpak Presto & GE Readymate.
The ReNu SU Technology cartridges are the heart of WMFTG’s Quantum pump, which offers a step change in pump technology by providing higher accuracy with flow linearity independent of back-pressure. This virtually pulse-free performance enables constant pressure, reducing possible damage to fragile media such as cells and enabling higher downstream process yields throughout the pressure range. The Quantum pump exceeds the performance of any other bioprocessing pump available.
Tony Barrass, Product Manager at WMFTG, commented, “Our sterile ReNu SU Technology cartridge assemblies guarantee quick and secure fluid path connections, allowing customers to reduce cost and shorten their supply chain while minimising risk. This new product reinforces WMFTG’s position as the leading provider of components for end-to-end fluid management in the biopharmaceutical industry.”
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