Sterilization of rubber stoper

Why we sterilized rubber stopers at 121 degree.
Why not exceed temperature.


If you sterilize rubber stoppers at a high temperature (e.g. >125°C), you could promote the generation of extractables and leechables from the stopper and impact product stability. Most suppliers specify the maximum temperature at which the stoppers can be sterilized without compromising its integrity.

Most rubber and plastic materials contain additives that contribute beneficial properties but can also be sources of organic extractables and leachables, substances that may migrate into pharmaceutical formulations. The choice of 121 degrees Celsius allows microbial contamination while minimizing the risk of adverse effects on material composition. Exceeding the tempertures recommended by the suppliers during sterilization could compromise the integrity of rubber stoppers, inducing undesirable changes in their properties.

Having said this… the difference in time/effectiveness of the sterilization cycle between 121 and higher temperatures, is not seignificant, since you at 121° you already achieve process lethality (F0) at a reate of 1:1.

I hope this helps. :slight_smile:

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Thanku so much

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