BioClamp WATSON MARLOW T Fluid Technology Solutions

Executive Summary This is the summary validation guide for BioClamps. Full test methods and results are available in the full validation guide, by filling in a request form on the website: https://www.wmfts.com/en/validation/request/

BioPure, Havant, UK produces BioClamps used in biotechnology and pharmaceutical manufacturing. BioClamps have the following features: • Lot numbers moulded in for full traceability BioClamps are suitable for use according to the conditions in Table 1. Table 1. Conditions for manufacturing, sterilisation, working and storage.

4b. USP <87> Biological reactivity tests, in vitro USP <87> determines the biological reactivity of cell cultures in response to samples. Test, positive and negative control samples were prepared at 37°C (98.6°F) for 24 hours. Biological reactivity was rated on a scale from Grade 0 (no reactivity) to Grade 4 (severe reactivity). Results: Grade 0 - No reactivity or cytotoxicity, passing USP <87> requirements. 4c. USP <88> Biological reactivity tests, in vivo USP Class VI Plastics Test assesses the toxicity of test articles systemically, intracutaneously and through implantation. Samples were immerged...

• Headspace Gas Chromatography-Mass Spectrometry (HS-GC/MS) to detect volatile compounds • Inductively Coupled Plasma-Mass Spectrometry (ICP/MS) to identify elemental impurities Results: Extractables were indicative of materials of construction. Validation testing services can provide further information in the evaluation of extractable data for risk assessment purposes. Please see section 5. There is a foreseeable shortage of gamma irradiation capacity. BioPhorum and Bio Process Systems Alliance (BPSA) committees have steered supply chain representatives to adopt X-ray irradiation to mitigate...

WATSON MARLOW f Fluid Technology Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS Liquid Filling Process Pumps ivAiarchitect single-use 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 Disclaimer: The information contained in this document is believed to be correct but Watson-Marlow Limited accepts no liability for any errors it contains and reserves the right to alter specifications without notice. It is the users responsibility to ensure...