Fluid Technology Solutions SUMMARY VALIDATION GUIDE Biotechnology and pharmaceutical products. Bioflex Ultra, Pharmaline N and Pharmaline X

This is a validation guide for Aflex Hose products suitable for the pharmaceutical and biotech industries. The guide contains instruction in section 8 on how to obtain the detailed test procedures and supporting test reports. Contents 1. Introduction 2. Conditions of use 1 Introduction 2 Conditions of use 3 Chemical compatibility 4 Materials, manufacturing and regulatory compliance statements d. Compliance declaration summary 5 Compendial and non compendial testing 6 Extractables on natural and anti-static PTFE hose liner 7 Hose Specification for non-adhesive bonded PTFE hose 8 Links to test...

4. Materials, manufacturing and regulatory compliance statements Hose liners are smooth bore and externally convoluted to provide flexibility. The liner is manufactured from PTFE in compliance with FDA CFR 21 177.1550. Anti-static PTFE liners contain high purity furnace black in compliance with FDA CFR 21 178.3297 and 3A 62-02 requirements. The liner has an outer stainless steel 316 helix wire wound into the external convolutions to provide additional hoop strength and kink resistance. Metallic support braid is stainless steel 316. A polypropylene braid is available for the Bioflex Ultra product,...

Results: No effects observed. Results: No effects observed. Results: No signs of toxicity. Results: No volatile, semi-volatile or non-volatile were observed in any extract solutions. No PFOA or PFOS were detected as expected. No PPVE was detected as expected. TOC results were below LOD or USP<661.1> limits. Elemental impurities are significantly below ICH-Q3D inhalation concentration limits and results are available for end user toxicological assessment. (For PTFE Natural and AS the ISO 10993-6, -10, -11 -12 are confirmed in the certificate attached to the main report) PTFE tube Natural 18-04239-G4...

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