Overview
Platinum-cured silicone braided hose
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High pressure flexible braided hose with continuously extruded Platinum-cured silicone core ensures product integrity while delivering increased pressure capability.
BioPure’s Platinum-cured silicone braided hose is supported by an industry leading validation package, meeting current industry requirements including ISO 10993: Parts 5, 6, 10, and 11, USP <88> and USP <87>.
The braided hose has also been evaluated for extractables using a multi solvent approach to BPOG guidelines. Quality management systems of the production facilities are certified to ISO9001.
- Manufactured and packed within an ISO 14644 Class 7 cleanroom
- Post sterilised validation to current USP, EU and FDA standards
- Withstands sterilisation and repeat autoclave
- Available in either 7.6m (25ft) and 15.2m (50ft) coils
Validation
BioPure high pressure braided hose and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:
- USP Biocompatibility in vivo and in vitro
- European Pharmacopoeia, 3.1.9
- ISO 10993
Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on BioPure high pressure braided hose, please download the high pressure braided hose validation summary guide
The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form
BioPure high pressure braided hose, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the compliance guide and is available on request by filling in the form found here.