Fluid Tech nology Group Validation guide and performance testing summary

4 Materials, manufacturing and regulatory compliance statements d. Compliance declaration summary 5 Compendial and non compendial testing BioPure based in Horndean, Hampshire produces a range of components for use in biotechnology and pharmaceutical manufacturing. BioPure’s Q-Clamp has a number of key features and benefits which makes it unique for clamping technologies. These include • Sleek lightweight design • Quick, single-handed and tool free clamping system • Compatibility with a wide range of connector geometries • Unique tamper evident identification technology The revolutionary Q-Clamp...

Table 1 details the different substances that are not present in the raw material, manufacturing processes or final composition of Q-Clamp. For full compliance statements please refer to the compliance summary sheet available on request from the website. Table 1: List of compliance statements for Q-Clamp and substances not found in the processing of or raw materials for Q-Clamp Q-Clamp has passed a number of compendial and ISO testing, a summary of the results are disclosed within.

5d ISO 10993-6 Biological evaluation of medical devices, implantation The purpose of this test is to evaluate the solid material in direct contact with living tissue. Strips of Q-Clamp (1mm x 1mm x 10mm) and the negative control plastics were tested. The test sites were examined for inflammation, encapsulation, necrosis, haemorrhage and discolouration macroscopically. Results: Q-Clamp did not demonstrate any remarkable difference as compared to the control implant sites when in contact with tissue for 2 weeks. Therefore Q-Clamp passed the requirements of ISO 10993-6. 5e ISO 10993-5 Biological...

Fluid Technology Group BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS MARLOW MARLOW FleXIC&n Pumps Tubing ASERCO Watson-Marlow Fluid Technology Group Watson-Marlow Fluid Technology Group 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 BioPure Technology Limited accepts no liability for any errors it contains and reserves the right to alter specifications without notice. Tri-Clamp is a registered trademark of Alfa Laval Corporate AB. Q-Clamp is used under...