ACF - Pharma Grade Silicone Tubing
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.
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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
- USP Physicochemical Test for Elastomeric Closures USP
- 29-NF24, 2006
- 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