Reusable Instrument Sterilization Method Validations

C

cjr978

#1
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
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I assume the differences in your marketing groups' suggestions have to do with different normal clinical practices (for the sterilization process) in the different countries.

If that's the case, I would assume that you would want to offer your customers an option to use one of three sterilization cycles (time, temperature, control parameters) that they each regard as "correct".

If that's the case, I don't see how you can avoid a multi-process validation.
 

pkost

Trusted Information Resource
#3
The sterilisation parameters differ between countries. Although hospitals/clinics are supposed to follow the instructions provided by the manufacturer they generally won't - it is too much hassle for them to change the parameters for every little device they process. consequently there are two approaches used by hospitals (at least in the uk)

1. Ignore the manufacturer and use their standard cycle
2. Demand the manufacturer provide validated instructions that use their standard parameters.

Option 1 is becoming less prevelent especially as hospitals now contract out the sterilisation and the service companies are not willing to take the risk/liability.



You would have to read the standard to verify that this is acceptable, but there should be some justification for worse case. In which case ask all the countries for their desired parameters, then validate at the lowest temperature for the shortest time.
 
#4
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

In a regulatory point of view, you have to provide (at least) one validated method to your customer. I forget were I see a table of equivalency of sterilization method (Temperature + time + pression). Maybe someone can help?

Ranab
 
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