BioBarb, FlatBioEndCap and BioEndCap

Product catalog summary

Introduction
BioPure, based in Hampshire, UK, manufactures components for biotechnology and pharmaceutical manufacturing, known for single-use fluid path components like BioBarb™, FlatBioEndCap™, and BioEndCap™. These are made from USP <88> Class VI material in ISO 14644-1 class 7 cleanrooms and comply with ISO 9001 quality management standards. They are suitable for sterilization by autoclave and gamma irradiation, offering features like full traceability, low extractables, and excellent chemical resistance.

Conditions of Use
BioPure components can be sterilized using gamma irradiation up to 50 kGy or autoclaved at 135°C for up to 30 minutes. They operate within a temperature range of -4°C to 40°C and can withstand pressures up to 4 bar.

Chemical Compatibility
These components are compatible with various fluids, including acids and bases, but should be tested under actual process conditions for specific applications.

Materials, Manufacturing, and Regulatory Compliance
Made from polypropylene, BioPure components are manufactured in ISO 14644-1 class 7 cleanrooms in the UK, complying with REACH and RoHS regulations. They should be stored in cool, dry conditions, maintaining original packaging where possible.

Compendial and Non-Compendial Testing
BioPure components have passed several tests, including USP <87> and <88> biological reactivity tests, ISO 10993 series tests for cytotoxicity, hemolysis, irritation, and systemic toxicity, and the Kligman maximization test for allergenic potential. They also comply with USP <85> endotoxin assay standards.

Extractables Testing
BioBarb connectors were tested for extractables using various chromatography and spectrometry methods. Results indicated the presence of extractables consistent with the materials of construction.

Conclusions
BioPure fluid path components have successfully passed numerous compendial and ISO tests. For detailed compliance statements and test reports, contact WMFTS representatives or visit their website.

Catalog excerpts

Fluid Technology Solutions Validation guide summary BioBarb, FlatBioEndCap and BioEndCap

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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...

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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...

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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...

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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...

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