What is the reason for commonly used sterilization temp. Between 300-350 degree celcius
Why not more than
400-500 ?
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Most glass vials used for sterile drugs must be depyrogenized to render them essentially free from endotoxins; while depyrogenation by dry heat can happen as low as 250°C, the higher the temperature the faster you get the level of apyrogenicity in the vials, which translates to a shorter tunnel or shorter oven cycles.
However, since the vials must be protected against further contamination by non-viable particles, these proceses are held under a unidirectional “first air” protection provided by HEPA filters. These HEPA filters are special because they have to be built of a material that can withstand the high temperatures needed for dry heat depyrogenation; and while these specific HEPA filters can tolerate high temperatures, most of them cannot withstand temperatures beyond 400°C.
In short, the limit on the high temperature is being set by the least heat resistant material in the process of depyrogenation. Sometimes HEPA filters, but other materilas can be affected as well, like materials for the tunnel, or any hardware that could be exposed to heat shock trasfered from the dry hot air.
Also, it would take a lot more time to reach high temperatures since these temperatres must be achieved by some level of ramping depending on the HEPA filters. This could take more time to set the line ready for production.
I hope this is useful.
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Thanku so much sir