Validations

The downloadable summary validation guide provides details of the product and material validations, along with instructions on accessing the available test reports. A summary of the validations included in more detail within the guide is noted below.

EN 16643:2016

Aflex Hose products fully comply with the European Norm EN16643 “Rubber and plastic hoses and hose assemblies – Non-Bonded fluoroplastic lined (e.g. PTFE) hoses and hose assemblies for liquid and gaseous chemicals – Specification”

USP Class VI <87> <88> & ISO 10993

Natural and Antistatic PTFE Hose Liners, Platinum Cured Silicone Rubber Covers (White and Clear) and EPDM Rubber Cover (Blue) have been tested in accordance with relevant USP VI, L929 MEM Elution Test and ISO 10993 protocols.

Extractable USP <661>

Draft USP <665> Physicochemical Test for Plastics

ICH-Q3D

BPOG

Natural and Antistatic (Carbon filled) Externally Convoluted Smoothbore PTFE hose has been tested in accordance with USP Physicochemical Test for Plastics, BPOG and ICH-Q3D and have met the relevant criteria.

FDA

The Materials used to manufacture the natural and AS (anti-static) PTFE Tube liner conforms to FDA 21 CFR 177.1550, and the antistatic PTFE liner conforms to FDA 21 CFR 178.3297.

Fire Resistance to BS5173 (Section 103.13 Part 6.2 and 6.3)

BK Grade Bioflex Ultra hose assemblies are "Fire Resistant". If DRC-300 is added at both ends, the assemblies are upgraded to "Fire Proof".

Other validations not currently summarised within available validation guides are:

Declaration of conformity, Plastic materials and articles intended to come in to contact with food

Aflex Hose Ltd declare that our PTFE flexible hose; Bioflex Ultra, Corroflon, Pharmaline N & X, Corroline+, Hyperline FX, Smoothbore and Bioflon in both natural (GP) and Anti-static (AS) forms are manufactured in compliance with the following laws, regulations and standards: Regulation (EC) No. 1935/2004; on materials and articles intended to come into contact with food, Commission regulation (EU) No.10/2011; relating to plastic materials and articles intended to come into contact with food and Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

3-A Sanitary Standards 62-02

Aflex Hose have 3-A Sanitary Standards approval for Bioflex Ultra, Pharmaline N and Pharmaline X product lines when assembled with appropriate end fittings. Assemblies are marked with the 3-A logo and product code to match the coding presented on the Aflex Hose 3-A certificate. Full details of 3-A assembly availability is included within the relevant full product brochure.

See the certification section for ISO 9001, IATF 16949, EHS, CE marking and other certifications.

Biotechnology/Pharmaceutical Validation Guide Rev 0

FDA compliance of PTFE - Material manufacturer declaration - AGC

FDA compliance of PTFE - Material manufacturer declaration - 3M

FDA compliance of Carbon Black (Anti-static PTFE liners) - Material manufacturer declaration - Cabot

REACH PAH compliance of Carbon Black - Material manufacturer declaration - JMB/Cabot