
APST-Siliconschlauch
Description
The APST hose from AdvantaPure® is an extremely flexible, particularly high-purity, platinum-cured and high-quality silicone hose. It is manufactured and packaged in a certified clean room in accordance with ISO 14644 class 7. BSE/TSE-free production and packaging are guaranteed. Due to this production method, it is predestined for sterile applications and is therefore the basic product for all silicone tubing systems manufactured for SINGLE USE applications.
The APST hose has been subjected to an extensive programme of physical, chemical and biological tests. A detailed description can be found in the specification section.
The APST hose is resistant to ozone and UV radiation and is characterised by good chemical resistance.
The hose is also suitable for sterilisation by autoclaving, radiation sterilisation (gamma radiation) and SIP/CIP cleaning.
The product is not suitable for continuous vapour application, as steam accelerates the natural ageing process of the silicone. Furthermore, the APST hose should not be used as an implant.
Due to its material advantages, the main areas of application are the pharmaceutical industry, medical technology and biotechnology.
Technical data
Due to the large number of possible internal diameters in combination with the wall thickness, you will find a list of the standard dimensions in the APST hose table, which you can request from TECNO PLAST.
50 +/- 5° Shore A quality (according to ASTM D 2240)
The APST hose can be used in a temperature range from -73.3 °C to +204.4 °C (depending on the medium).
Specification
The APST hose is manufactured from a specified raw material in 50 +/- 5 Shore A quality (designation NI 201). This quality fulfils the following guidelines, among others:
- FDA 21 CFR 177.2600
- USP <85> Bacterical Endotoxin Test
- USP <87> In Vitro, L929 MEM Elution Test
- USP <88> In Vivo, USP Class VI
- USP <381> Elastomeric Closures for Injection Test
- USP <661> Physicochemical Test for plastics
- USP <788> Microscopic Particle Count Test
- ISO 10993-3, -4, -10 und -11
- Europäische Pharmakopöe 3.1.9.
- 3A Sanitary Standard
The product was also subjected to an extensive extractables study.
All tests have been carried out on the end product at accredited laboratories. The comprehensive validation programme is available on request.
