MARLOW r Fluid Technology Solutions Validation guide summary

4. Materials, manufacturing and regulatory compliance statements 1 Introduction2 Sterilisation a. Materials of construction d. Compliance declaration summary Watson-Marlow Flow Smart, Inc., based in Seaford, Delaware, USA produces a range of Platinum-cured silicone gaskets for use in biotechnology and pharmaceutical manufacturing. The facility contains 3,000 square feet of cleanroom manufacturing. Watson-Marlow Fluid Technology Solutions (WMFTS) manufactures its BioPure branded Platinum-cured silicone gaskets in its FlowSmart ISO 14644 class 7 cleanroom according to GMP principles within a facility...

4d Compliance declaration summary Table 1 details the different substances that are not present in the raw material, manufacturing process or final composition of BioPure Platinum-cured silicone gaskets. For full compliance statements please refer to the compliance summary sheet available from the website on request. 5b USP <87> Biological reactivity tests, 5d In Vitro, post sterilisation samples USP <87> determines the biological reactivity of a cell culture in response to a given test article. Samples of BioPure Platinum-cured silicone gaskets were tested in accordance with USP39, NF 34, <87>,...

Results: BioPure Platinum-cured silicone gaskets meet the requirements of ISO 1099310 guidelines for incutaneous injection. Results: BioPure Platinum-cured silicone gaskets meet the requirements of ISO 10993-11 guidelines for systemic toxicity. Results: BioPure Platinum-cured silicone gaskets had an EU/mL value of 0.005 which is less than the value of 0.25 EU/mL stated for water for injection. Results: Extracts from BioPure Platinum-cured silicone gaskets contained one particulate less than 10 microns or smaller and one particulate less than 25 microns or smaller. Table 3: List of test parameters...

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 Platinum-cured silicone gaskets HB0620 Issue 3 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...