Fluid Technology Solutions Validation guide summary BioBarb, FlatBioEndCap and BioEndCap

Contents 1 Introduction2 Conditions of use 1. Introduction BioPure based in Hampshire, UK manufactures a range of components for use in biotechnology and pharmaceutical manufacturing. In particular, it is well known for its singleuse fluid path components. These include: • BioBarb™ - Hose tail to Tri-Clamp adaptors • FlatBioEndCap™ - End caps for connectors • BioEndCap™ - End caps with pull tab • Full traceability as the LOT number and size identification are permanently molded • Very low extractable, non-toxic and animal derived content free • Comprehensive stock of a wide range of sizes • Excellent...

BioPure fluid path components are suitable for sterilisation using either gamma irradiation or autoclave. BioPure fluid path components are suitable for gamma irradiaton to 50 kGy, and autoclaved to 135C (275F) for up to 30 minutes. 2a Working temperature range and pressure rating The working temperature range of BioPure fluid path components is between -4C to 40C (24.8 F to 104F). BioPure fluid path components can be used up to 4 bar (58 psi). Based on the material of construction, BioPure fluid path components should be compatible with a variety of fluids including weak and strong acids and...

5e ISO 10993–5 Biological evaluation of medical devices - part 5: tests for In Vitro cytotoxicity The biological reactivity of a cell culture, in response to extracts from BioBarb was determined. The maintenance medium on the cell cultures was replaced by extracts of BioBarb or control article. The cell cultures were incubated for 48 hours at 37±1C (98.6F±33.8F). Biological reactivity was evaluated by a photo spectrometer at 450 nm wavelength. Results: BioPure fluid path components showed no signs of cytotoxic potential. Therefore they passed the requirements of ISO 10993–5. 5f ISO 10993–6 Biological...

Fluid Technology Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS Watson-Marlow Fluid Technology Solutions Watson-Marlow Fluid Technology Solutions supports its customers locally through an extensive global network of direct sales operations and distributors Copyright © 2022 Watson-Marlow Fluid Technology Solutions Validation guide summary: BioPure BioBarb, FlatBioEndCap, BioEndCap HB0670 Issue 3 Disclaimer: The information contained in this document is believed to be correct but BioPure accepts no liability for any errors it contains and reserves the right to alter specifications without...