Platinum-cured silicone braided hose

Product catalog summary

Introduction
Watson-Marlow Flow Smart, Inc. manufactures Platinum-cured silicone braided hoses for biotechnology and pharmaceutical industries. These hoses are produced in a GMP-compliant, ISO 9001 certified cleanroom in Seaford, Delaware, USA. They offer high pressure flexibility, sterilization capability, and full product traceability.

Sterilization and Conditions of Use
The hoses can be sterilized using autoclave and gamma irradiation up to 50 kGY and function effectively between –65C to 254C (–85F to 490F).

Chemical Compatibility
No specific chemical compatibility data is provided; testing under actual conditions is recommended.

Materials, Manufacturing, and Regulatory Compliance

Materials: Made from polydimethylsiloxane reinforced with polyester.
Manufacturing: Produced in an ISO 14644 class 7 cleanroom.
Origin: USA.
Compliance: Meets REACH and RoHS regulations.
Storage: Store between 5C to 30C, away from sunlight.

Compendial and Non-Compendial Testing
The hoses have passed tests including USP <87>, USP <88>, ISO 10993 series, and European Pharmacopeia 3.1.9, showing no cytotoxic potential, no toxicity, no haemolytic activity, and passing irritation and systemic toxicity tests.

Extractables Testing
Testing using chromatography and spectrometry methods shows extractables consistent with the materials of construction.

Conclusions
BioPure Platinum-cured silicone braided hoses meet multiple regulatory and safety standards, suitable for biopharmaceutical applications.

Specifications and Compliance
The document provides a compliance summary and validation guide for the hoses. Detailed compliance statements and test reports are available on the WMFTS website.

Testing and Evaluation
The hose has been evaluated using various compendia and ISO testing methods. Results are summarized in Table 3, listing test parameters and results for E.P. 3.1.9.

Conclusions
The evaluation confirms the suitability of the BioPure hose for specific applications. For more information, contact a WMFTS representative.

Company Information
Watson-Marlow Fluid Technology Solutions supports customers globally through a network of sales operations and distributors and is part of Spirax-Sarco Engineering plc.

Disclaimer
The document includes a disclaimer that while the information is believed to be correct, Watson-Marlow Limited accepts no liability for errors and reserves the right to alter specifications without notice. Users must ensure product suitability for their applications.

Catalog excerpts

r Fluid Technology Solutions Validation guide summary

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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....

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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,...

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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...

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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 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...

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