- Perspectiva
Saint-Gobain statement of change notification (29th May 2018)
Removal of FDA compliance for Versilon TLCT/SFTL, WTLCT, CTL, PSTLCT (PharmaSmooth), TLCTO, WSIB
- Four (4) CMR (Carcinogenic, Mutagenic and toxic to reproduction) substances identified
- Inner fluid contact layer does not act as a functional barrier to external layers that contain adhesives for bonding hose construction
Aflex Hose are keen to emphasise the significant differences in construction between adhesive bonded constructions (e.g TLCT) and the Aflex non-adhesive construction ( Bioflex Ultra, Pharmaline N, Corroflon, Pharmaline X, Corroline+, Hyperline Range, Smoothbore and Visiflon)
Adhesive bonded constructions (e.g TLCT)
- Inner core layer (FEP)
- External layer bonded to the inner core with adhesive
- Strengthening layers 9e.g0 braid, material, wrap) embedded within rubber layers and bonded
- Manufacturers often only claim validation compliance for the liner material
This type of construction is prevalent within the hose industry and products will comply with technical standards. A common standard for an adhesive bonded construction is EN 12115, which requires a minimum adhesive strength between the layers of the construction.
Adhesive bonded construction from Saint-Gobain TLCT
Non-adhesive bonded construction - Aflex Hose
Aflex Hose Ltd manufacture to the European technical standard EN16643
''EN 16643: Rubber and plastics hoses and hose assemblies - Non-Bonded fluoroplastic lined (e.g PTFE) hoses and hose assemblies for liquid and gaseous chemicals - Specification''
Bioflex Ultra with EPDM / Silicone cover
Aflex hose products do not utilise an adhesive bonded construction. Aflex Hose have full FDA and USP validations for all materials of construction.
PTFE liner SS316 helix and SS 316 braid
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