BS EN ISO 9001:2008

Aflex products are all manufactured in accordance with BS EN ISO 9001: 2008 Quality Management Systems independently assessed and registered by National Quality Assurance Limited (NQA).

USP Class VI and ISO 10993-5, 6, 10 & 11 Guidelines

Natural and Antistatic PTFE Hose Liners, Platinum Cured Silicone Rubber Covers (White and Clear) and EPDM Rubber Cover (Blue) have been independently tested in accordance with USP protocols and are found to conform to the requirements of USP Class VI Chapter <88>.

Natural and Antistatic PTFE Hose Liners, Platinum Cured Silicone Rubber Covers (White and Clear) have also been tested in accordance with USP protocols and are found to conform to the requirements of USP Class VI Chapter <87>, the L929 MEM Elution Test and are considered non-cytotoxic.

FDA

The Materials used to manufacture the natural PTFE Tube liner conforms to FDA 21 CFR 177.1550, and the antistatic PTFE liner conforms to FDA 21 CFR 178.3297.

3-A Sanitary Standards

The PTFE used in the liner is manufactured solely from materials which meet the requirements of the 3-A Sanitary Standards

Pharmaceutical Manufacturers Approvals

Most of the major pharmaceutical manufacturing companies in the world have audited and/or approved Aflex Hose as a Hose Supplier.

BPSA Leachables and Extractables Testing

Aflex Hose Natural and Antistatic PTFE Hose Liner Tube has been independently tested in accordance with BPSA recommendations, and found to be satisfactory.

Copies of the Test Report are available for specific assessments to be made.

CE Marking (Europe only)

Aflex has been assessed by Zurich Engineering and found to comply with the Pressure Equipment Directive 97/23/EC (European Community) Conformity Assessment Module D1, approved to CE Mark applicable hose products, accompanied by a Hose Usage Data Sheet, and a Declaration of Conformity.

Attestations of Conformity to ATEX Directive 94/9/EC (Potentially Explosive Atmospheres)

Available for hose and assemblies for components used in Gas Zones 1 & 2 and Dust Zones 21 & 22, when applicable.

Material Certification to EN10204

Available for all the hose or hose assembly components.

Certificates of Conformity to EN45014

Are available for all products.

Hose Testing

Each assembly is pressure tested to 1.5 times maximum working pressure before despatch, and pressure test certificates can be supplied.