Material Guide

CerCell products are based on

The Material Guide is constantly undergoing improvement and dated August 2016. Remember not all materials are in media contact! Be surprised that some materials even complying with the requirements of FDA, modified ISO 10993-1 and USP Class VI are not cell friendly! CerCell offer and recommend that user test a range of material samples on users specific media and cell line.

3D printed components:

  • Polyamide PA2201 in compliance with FDA, CFR 21 §177.1500 9 (b) based on Vestamid-L P12 resin manufactured by Evonik, bio compatible according to EN ISO 10993-1 and USP VI/121 °C , approved for food contact in compliance with the EU Plastics Directive 2002/72/EC (exception: high alcoholic foodstuff).

Sheet used for vacuum forming, such as head plate, bottom, baffels and containers:

  • PETG, Polyethylene Terepthalate Glycol, IPB B.V., Veralite 200, FDA food grade compliant.
  • Thermoplastic co-polyester, Bayer, Germany, Vivak, suitable for food contact applications.
  • Thermoplastic PC, polycarbonate, Bayer, Germany Bayblend FR 3030, medical systems.
  • Thermoplastic PC, polycarbonate, Bayer, Germany, Makrolon.

Tubes, external as well as internal tubes:

  • PC, polycarbonate tubes manufactured by Cevacril, Italy based Bayer Makrolon ET3313 standard resin.
  • PC, polycarbonate tubes manufactured by Cevacril, Italy based on Bayer Makrolon 3208, complies with FDA regulation CFR 21- § 177.1580 “Polycarbonate resins” for food contact applications up to 100 °C.
  • PC, polycarbonate tubes manufactured by K-Mac Plastics based on GE Lexan 124 or 104 resin, FDA food contact compliant.
  • PC, polycarbonate tubes manufactured by AP-extrusion based on AP5001-03 resin.
  • PMMA, acrylic tubes Esacril manufactured by Cevacril, Italy comply with FDA CFR 21 §177.1010.

Injection moulded components, such as PG13,5 plug, container, head plate, tubes:

  • Polycarbonate Bayer, Germany, Makrolon 2858, medical grade, complies with the requirements of FDA, modified ISO 10993-1 and USP Class VI

Porous bodies:

  • PE, polyethylene Hoechst, Germany, Hostalen-G.

Griffin beakers:

  • PMP, polymethylpentene from VitLab, Germany.

Adapters, structural parts, special made:

  • Polyamide, from Ensinger, Germany.
  • Polyamide, Ertacetal-C from Quadrant, USA, FDA food grade compliant.
  • Polyamide, POM natur from Quadrant, USA, FDA food grade compliant.
  • Polycarbonate TECADUR from Ensinger, Germany, resin Eastman Tritan copolyester MX710, medical grade, complies with the requirements of FDA, modified ISO 10993-1 and USP Class VI.

Rubber seals:

  • Red silicone compound WMQ #714177 comply with FDA regulations CFR 21 §177.2600 and European legislation EC 1935/2004.

Barb fittings, valves, fittings, Luer-Tapers, Luer-Lok:

  • Manufactured by Colder Product Company (CPC), USA.
  • Manufactured by Value Plastics, USA.
  • Sterile gas filters manufactured by ZenPure. USA.

Silicone hoses:

  • Various silicone hose qualities manufactured by Saint-Gobain, France.
  • C-Flex thermoplastic silicone hoses manufactured by Saint-Gobain, France.
  • Standard compound SL601 manufactured by Lindemann, Germany, FDA food grade compliant.

Adhesives:

  • Silicone adhesive DOW Corning 732, food grade, transparent.
  • Silicone adhesive DOW Corning Silastic A, medical grade, transparent.
  • UV curing transparent acrylic adhesive, Cyperbond 305, medical grade, ISO 10993-5.
  • Cyanoacrylate transparent adhesive, Cyberbond 2003, medical grade, ISO 10993-5.

Structural materials inside SUB / SUF:

  • Alumina ceramics as bearing material, when MST driven.
  • Parylene coated rare earth metal magnets, the biocompatible coating comply with FDA regulations and USP class VI, when MST driven.
  • AISI316L, DIN 1.4404 structural Stainless Steel material.

Irradiation performed by and certified by www.sterigenics.com

END