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Pharma-Silicone-Tubing


 

Pharma Grade Silicone Tubing (manufactured in a cleanromm ISO Class 7 )

Our platinum cured pharma grade silicone tubing is manufactured in a cleanroom ISO Class 7.

The manufacturing of the platinum cured tubing is separated from the manufacturing of peroxide cured tubing. No crosscontamination between both qualities.

The raw material has passed several biocompatibility tests:
  • FDA regulations CFR 177.260
  • European pharmacopoeia 5.3, 2006 Chapter 3.1.9
  • United states pharmacopoeia Class VI
  • USP Physicochemical Test for Plastics USP 29-NF 24, 2006 <661>
  • USP Physicochemical Test for Elastomeric Closures USP
  • 29-NF24, 2006 <381>
  • ISO 10993 requirements
  • In Vitro Hemocompatibility Assay ISO 10993-4
  • Systemic Injection Test ISO 10993-11
  • Kligman Maximisation Test ISO 10993-10
  • Intracutaneous Injection Test ISO 10993-10
  • Rabbit Pyrogen Test ISO 10993-11
  • Hemolysis Direct Contact ISO 10993-4
  • Elution Test ISO 10993-5
  • Agar Diffusion Test ISO 10993-5

Datasheet(non-braided tubing)
Datasheet (braided tubing)


Some pictures from the manufacturing:


www.acftec.de Applied Critical Fluids GmbH - Industriestrasse 53 - 68169 Mannheim - Tel.: +49 (0) 621 309 809 30 - Fax.: +49 (0) 621 309 809 399 - email: info(at)acftec.de