Hello,
I am currently preparing for a Steam Quality Test for a high-pressure steam sterilizer.
When performing the Steam Quality Test using the actual load pattern cycle, it takes more than 1 to 2 hours per test. I am wondering if there are any pharmaceutical companies that create a separate sterilization cycle specifically for Steam Quality Testing.
In my opinion, since the measurement is taken during the pulse phase, it might be acceptable to use a cycle that matches the same number of pulses as the actual load pattern but includes only the sterilization phase (minimum 15 minutes).
EN 285 only specifies the minimum sterilization time, but there are no detailed guidelines regarding this matter.
I would greatly appreciate any advice or insights you could share.
Thank you in advance for your response.