Fluid Technology Solutions SUMMARY VALIDATION GUIDE Food and Beverage hose products Bioflex Ultra, Pharmaline N, Pharmaline X, FaBLINE

This is a validation guide for Aflex Hose products suitable for the Food and Beverage industry. 4 Materials, manufacturing and regulatory compliance statements d. Compliance declaration summary 5 Food testing compliance a. Taint and odour testing b. Overall migration testing c. Specific migration testing d. Annex 1 - Union list substances e Chinese food testing 6 Hose specification for non-adhesive bonded PTFE hose Aflex Hose is based in West Yorkshire, UK, and manufactures PTFE lined hose products. The facility manufactures from raw materials (e.g. PTFE granulated powder, braid wire, stock bar)...

4. Materials, manufacturing and regulatory compliance statements All raw materials, compounds used in the manufacturing process and the final Aflex Hose products comply with the REACH regulations. None of the chemicals used in the manufacture of Aflex Hose products are on the candidate list or the list of substances of very high concern (SVHC). 4a Materials of construction 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...

5f EU 2016/1416 amending regulation EU 10/2011 Aflex Hose products and testing meet the requirements of the amendment EU 2016/1416 that applies to EU 10/2011. 5g 3-A sanitary standard The Bioflex Ultra rubber covered, Pharmaline N, Pharmaline X and FaBLINE products, with particular end fitting configurations and appropriate ferrule seals comply with the 3-A 62-02 (hose assemblies) sanitary standard. Contact Aflex Hose for further details on the specific configurations that are covered by the 3-A certification. 5h Declaration of compliance to EU 10/2011 as required by article 15 and annex IV Aflex...

WATSONMARLOW Solutions FOOD AND BEVERAGE SOLUTIONS Liquid Filling SSmcisosine Process Pumps 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 wmfts.com/global WM Disclaimer: The information contained in this document is believed to be correct but Aflex Hose Ltd accepts no liability for any errors it contains and reserves the right to alter specifications without notice. It is the users responsibility to ensure product suitability for use within their application....