Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello fellow RAPs members,

My company is performing a sterilization validation to ensure that our device can be processed safely in accordance with the UK requirements (Sterilization temperature 134 ºC (Maximum Temperature 137 ºC) for a minimum holding time of 3 minutes). 

If I am understanding correctly, the maximum temperature is specified because most autoclaves set for a 134ºC  sterilization cycle actually get hotter than the set temp, but are we actually required to reach the max temp as part of the validation?  For example, the cycle log for our autoclave has shown the temp to reach 135.6 ºC, but has not gone as high as 137ºC; does this mean our validation data is not sufficient, or is it enough that the temperature was within the specified range for sterilization?

Thanks!

Hello Anon,

From my understanding there are different temperatures which can be used for dry heat and moist heat sterilisation, depending on the country or region.  As an example, the time and temperature can vary between countries in Europe from 3 minutes up to 18 minutes.  The idea with stating the maximum temperature is preventing thought process that if I increase the temperature then I should be able to reduce the dwell time.  So it is not so much about showing the cycle has reached maxed temperature, but important to monitor the temperature profile during the validation supporting the "set point" of 134C.  Without seeing the actual protocol or results of the report, I would probably say the validation is sufficient as long as the temperature was in the range specified in the protocol (and meeting the local requirements).

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 14-Apr-2022 10:22
From: Anonymous Member
Subject: Sterilization Validation - UK Requirements

This message was posted by a user wishing to remain anonymous

Hello fellow RAPs members,

My company is performing a sterilization validation to ensure that our device can be processed safely in accordance with the UK requirements (Sterilization temperature 134 ºC (Maximum Temperature 137 ºC) for a minimum holding time of 3 minutes).

If I am understanding correctly, the maximum temperature is specified because most autoclaves set for a 134ºC  sterilization cycle actually get hotter than the set temp, but are we actually required to reach the max temp as part of the validation?  For example, the cycle log for our autoclave has shown the temp to reach 135.6 ºC, but has not gone as high as 137ºC; does this mean our validation data is not sufficient, or is it enough that the temperature was within the specified range for sterilization?

Thanks!