The A6093 Product Family
The A6093 product family comprises different products, the core tubing consists of a platinum-cured extruded silicon:
- A6093 platinum-cured silicon tubing without reinforcement
- AE6093 platinum-cured silicon tubing with reinforcement (fabric)
- AES6093 platinum-cured silicon tubing with reinforcement (fabric) for RE-LINK SI
These especially – intended for pharmaceutical/biotechnological uses – developed products consist of a specific material (60 Shore base material) and are produced according to a special production process that is established upon detailed quality agreements with the manufacturer.
Standards – Regulations
Comprehensive testing have been performed using representative A6093 end product samples. All transparency silicon tubing of A6093 quality are compliant with the following (coloured translucent silicon tubes are excluded):
- European Pharmacopoeia 3.1.9.:
Silicone Elastomer for Closures and Tubing
- European Framework Regulation (EC) 1935/2004 and German Foods, Consumer Goods and Foodstuff Code (LFBG) as well as BfR recommendations, XV Silicone
- Biological Reactivity in vivo, USP General Chapter <88>, Class VI + 121 °C (Systemic Intravenious, Intracutaneous Irritation, Systemic Intraperitoneal, Intramuscular)
- Biological Reactivity in vitro,
- ISO 10993-5/USP General Chapter <87>:
Determination of Cytotoxicity, MEM Elution
- Bacterial Endotoxins (Limulus-Amebocyte-Lysate-Test),
USP General Chapter <85>
- Rabbit Pyrogen Test, USP General Chapter <151>
- Bioburden (Quantitative Detection, DIN EN ISO 11737, Part 1)
- Particles, International Pharmacopoeia (WHO) 5.7
Sample preparation corresponds to or exceed ISO 10993-12 recommendations, utilization of specific analytical methods (HS-GC/MS, GC/MS, LC-MS, ICP/MS
- Ongoing characterization (qualification/validation)
- Extractables - Identification (IR), European Pharmacopoeia 3.1.9., 2.2.24
- Acidicy/Alkalinity, European Pharmacopoeia 3.1.9.
- Reducing Substances, European Pharmacopoeia 3.1.9.
- Thermoanalysis (DSC), European Pharmacopoeia 2.2.34/ USP General Chapter <891>
- Elemental Impurities
- EMEA/CPMP/SWP/4446 – Guideline on the specification limits for residues of metal catalysts or metal reagents, ICH Q3D – Guideline for Elemental Impurities ICP/MS according to European Pharmacopoeia 5.20 / 2.4.20 / 2.2.58 and USP General Chapters <232> / <233> / <730> / <1730>
- Tests according to USP General Chapter <661.1> Plastic Materials of Construction
- Biological Reactivity in vitro and in vivo (see above)
- Physicochemical tests
- Compliance with food contact requirements (see above).
All detected extractable substances have been reviewed by toxicological experts (DGPT/Eurotox Registered Toxicologists (ERT)). They have been assessed to be of no toxicological concern and to do not present a health risk to the patients.
Regulatory Support File
As a special service, we have summarized all results in a very comprehensive “Regulatory Support File of the A6093 Silicon Tubing Product Family”. It is available upon request.
All silicon tubing from TECNO PLAST is also free from animal-derived materials and meet the requirements of the TSE Guideline EMA/410/01 of the European Union.
In conclusion, we can provide you specific customized solutions for all applications.
- Standard packaging of A6093 platinum-cured silicon tubing: Tubing coil fixture: A6093 silicon tubing
- Non-perforated PR bags (pharma quality – EP 3.1.3)
- Not imprinted or imprinted with white ink (standard) – ink is free from benzophenone! Laser-engraving is under devolpment.
All types correspond to DIN EN 16821:2017-10