C
I was hoping someone might be able to help. We are looking at doing some reusable instrument sterilization validations and have some conflicting requirements:
Our US team wants to validate to 4 mins at 132 celsius using the partial cycle BI approach in ISO17665
Our UK team wants to validate to 3 mins at 134 celsius they dont care which approach but a local company believes that the BI full cycle approach in ISO17665 is most appropriate. This i believe is as the partial cycle approach wont provide a suitable sterility assurancy level and the 3 mintue requirement is set down in the MHRA's HTMs
Our German team wants to validate to 5 mins at 134 celsius but says that we should be using physical measurements of pressure and temperature during the process to validate (which I assume to be the approach of ISO17665 saying that you can follow standard settings in a local pharmacopoeia - this case being EU). They say that although the BI method is valida the german market wont accept it.
Can anyone tell me definatively what the requirements are in each market and is it possible to do one validation that covers all eventualities?
thanks
Chris
Our US team wants to validate to 4 mins at 132 celsius using the partial cycle BI approach in ISO17665
Our UK team wants to validate to 3 mins at 134 celsius they dont care which approach but a local company believes that the BI full cycle approach in ISO17665 is most appropriate. This i believe is as the partial cycle approach wont provide a suitable sterility assurancy level and the 3 mintue requirement is set down in the MHRA's HTMs
Our German team wants to validate to 5 mins at 134 celsius but says that we should be using physical measurements of pressure and temperature during the process to validate (which I assume to be the approach of ISO17665 saying that you can follow standard settings in a local pharmacopoeia - this case being EU). They say that although the BI method is valida the german market wont accept it.
Can anyone tell me definatively what the requirements are in each market and is it possible to do one validation that covers all eventualities?
thanks
Chris