FDA compliance and USP VI approval

Material no. Polymer type Color Temp. (min) Temp. (max) Temp. °F (min) Temp. °F (max) Approval by
Certification   Attestation
FDA 21CFR 177.2400 (d1)+(d2) FDA 21CFR 177.2600 (e)+(f) USP VI 120° 3A-Sanitary Standard   (EG) Nr. 1935/2004 EHEDG ADI free
FDA-261 FFKM white –20°C +260°C -4°F +500°F  
FDA-260 FFKM black -20°C +260°C -4°F +500°F  
FDA-231 FEPM white -15°C +230°C +5°F +446°F  
FDA-230 FEPM black -15°C +230°C +5°F +446°F  
FDA-201 FKM white -20°C +200°C -4°F +392°F  
FDA-200 FKM black -20°C +200°C -4°F +392°F  
FDA-181 EPDM white -50°C +180°C -58°F +356°F  
FDA-180 EPDM black -50°C +180°C -58°F +356°F  
FDA-151 HNBR white -40°C +150°C -40°F +302°F  
FDA-150 HNBR black -40°C +150°C -40°F +302°F  

Excellent purity in the food and pharmaceutical areas!

Elastomers, which are used in the food and pharmaceutical industries, are subject as a rule to the strict regulations of the FDA and USP approvals. Createc possesses FDA compliance for all its elastomer materials, i.e. FFKM, FEPM, FKM, EPDM as well as HNBR and will even supply seals in a white or black design upon request.

Furthermore CREAFLEX® FFKM extraction data satisfies the strict FDA requirements for perfluor elastomers according to 21 CFR177.2400 (d1) and (d2) and in certain cases, clearly surpassed (change from beat) the required limits established by the FDA guidelines.

Material properties:

  • FDA compliance for all CREAFLEX® elastomers FFKM, FEPM, FKM, EPDM and HNBR
  • USP VI approval for all CREAFLEX® materials
  • CREAFLEX® FDA elastomers undermatch the requested FDA and USP VI guidelines
  • Excellent purity, safety and environmental compatibility
  • Very long service life


CREAFLEX® food grade elastomers with FDA compliance for 100% purity and safety in the production process

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