r Fluid Technology Solutions Validation guide summary

1. Introduction Watson-Marlow Flow Smart, Inc., based in Seaford, Delaware, USA produces a range of Platinum-cured silicone braided hose for use in biotechnology and pharmaceutical manufacturing. The facility contains 3,000 square feet of cleanroom manufacturing. 1 Introduction 2 Sterilisation 3 Chemical compatibility 4 Materials, manufacturing and regulatory compliance statements a. b. c. d. e. f. g. Materials of construction Manufacturing environment Country of origin Compliance declaration summary REACH legislation RoHS Storage conditions 5 Compendial and non compendial testing a. b. c. d....

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 braided hose. 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 braided hose were tested in accordance with USP39,...

Results: BioPure Platinum-cured silicone braided hose meet the requirements of ISO 10993-10 guidelines for incutaneous injection. Results: BioPure Platinum-cured silicone braided hose meets the requirements of ISO 10993-11 guidelines for systemic toxicity. Results: The skin sites that were exposed to the test articles and negative control showed no signs of erythema or edema. Therefore, BioPure Platinum-cured silicone braided hose is deemed not to contain any allergic potential. Results: BioPure Platinum-cured silicone braided hose had an EU/mL value of 0.005 which is less than the value of 0.25...

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 braided hose HB0619 Issue 2 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...