The sterilisation of devices and components made of plastic is designed to destroy as many living microorganisms such as bacteria, viruses, algae and their spores as possible. There are several methods for sterilisation of plastics. Depending on the sterilisation process used, some materials are more suitable than others.
In accordance with DIN EN 285, all surfaces of the objects being sterilised must be exposed to pure saturated water vapour at 134 °C for at least three minutes. Steam sterilisation or autoclaving is regarded as the safest and cheapest of all the sterilisation methods. However, the high process temperatures involved makes it less suitable for materials sensitive to heat and hydrolysis.
TECAPEEK MT shows no significant loss of mechanical properties, even at more than 1,500 sterilisation cycles. Also, further negative influences like discolouration or colour change (yellowing), or even calcification are not seen above 1,500 cycles.
TECASON P MT shows no significant loss of mechanical properties until 800 sterilisation cycles. Also, significant discolouration is not seen below 1,000 sterilisation cycles.
TECAPRO MT shows no significant loss of mechanical properties until 800 sterilisation cycles. However, discolouration and colour change (yellowing) is seen at 200 sterilisation cycles (does not apply to TECAPRO MT black).
Sterilisation tests were performed using plastic test specimens without cleaning cycles. The sterilisation temperature was 134 °C with a sterilisation time of 10 min. and a drying time of 20 min. The chamber pressure was 3 bar. Other effects influencing the cleaning process (with Ecolab, Borer etc.) were not investigated. Due to the chemical resistance of the individual materials and practical experience it must be assumed that the cleaning cycles have a significant influence on the sterilisation resistance. The sterilisation resistance, in particular of PP-HT, is significantly impaired by this. It must therefore be assumed that the sterilisation resistance will be significantly lower than described. We typically define PP-HT with approx. 200 sterilisation cycles.
Sterilisation using a microbiocidal gas such as formaldehyde or ethylene oxide is always carried out at temperatures between 48 °C and 60 °C. Due to the low temperatures, this process is suitable for temperature sensitive materials. The efficiency of formaldehyde is comparable to that of ethylene oxide, but its lower toxicity permits shorter degassing times. Both are mainly used for disposable articles.
With hot air sterilisation, germs are killed off by dry heat under high thermal load (180 °C) over a period of at least 30 minutes. This process is no longer permitted due to a large number of uncertain factors and has therefore now been replaced by other methods in most cases.
In particular for medical technology, we offer a comprehensive range of processing methods as well as customised profiles and tubes to meet your individual requirements for your finished or semi-finished part.
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