Fluid Technology Solutions Validation guide summary

Contents statements 1 Introduction2 Conditions of use3 Chemical compatibility 4 Materials, manufacturing and regulatory compliance d. Compliance declaration summary 5 Compendial and non compendial testing Watson-Marlow’s PureWeld XL (942.) TPE tubing is USP 88 Class VI and ISO 10993 compliant, and produced from a USP 88 Class VI raw material. It is manufactured in an ISO 14644-1 class 7 cleanroom. The cleanroom is temperature and humidity controlled, thereby providing a stable extrusion environment. PureWeld XL TPE tubing exhibits a number of key features: • Low particulate generation in peristaltic...

Table 1: List of compliance statements for Pureweld XL tubing and substances not present in the manufacture of Pureweld XL Animal Derived Content - - Presence of heavy materials - - '-' denotes not present or not added For a complete range of compliance statements relating to PureWeld XL please refer to the compliance guide 4e REACH legislation 4g Storage conditions Named substance/compliance statement Raw material Manufacturing process Final product Table 2: List of compendial and non compendial testing performed Test reference Test Description Result USP <87> Biological Reactivity tests, In...

5e ISO 10993-5 Biological evaluation of medical devices - part 5: tests for In Vitro cytotoxicity The biological reactivity of a cell culture, in response to extracts from PureWeld XL tubing was determined. The maintenance medium on the cell cultures was replaced by extracts of PureWeld XL tubing or control article. The cell cultures were incubated for 48 hours at 37±1C (98.6F±33.8F). Biological reactivity was evaluated by a photo spectrometer at 450 nm wavelength. Results: PureWeld XL tubing showed no signs of cytotoxic potential. Therefore they passed the requirements of ISO 10993-5. 5f ISO...

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