ETO Sterilisation of Single Use Part supplied in Non-Sterile State

[bio_subbu]

Sir

We have claimed that 7.5.1.2.1 is not applicable
a) product is NOT cleaned by the organization prior to sterilization and/or its use

Hi Priya

Since you are manufacturing non sterile accessory, it is subject meet the clause 7.5.1.2.1 b) of ISO 13485 “product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use”, As I said in my previous reply you need to have a minimum control in cleanliness of the product. You can use disinfectants to clean the accessory, prior to use check which type of disinfectants withstand your product (for eg. Iso prophyl alcohol). Also, do the validation study before and after cleaning with disinfectant. (This can be verify through bio-burden analysis and find out the percentage of microbial reduction level). Based on the result, you can have a control on the specific process.

Also, I suggesting that do the sterility validation in different ways that use cleaned material (packed condition), sterilize by ETO and do sterility test. (if don’t have in-house laboratory do the test in outside testing agencies)

If the test failed from the sterility, the one of the reason is high microbial load in your accessory/product.

Regards
S. Subramaniam

 

[priya]

subbu

thank you very very much.... although i was wondering "how to introduce cleaning at supplier's end" and was thinking in terms of clean room and everything, your simple idea seems to solve the problem immediately.. But please tell me, if I write in the user manual "Please clean with IP before sterilisation" will it still be acceptable to meet the 7.5.1.2.1? please answer this q and I will let this thread rest.

Priya

 

[Burgmeister]

How can you say that EtO sterilization will be effective if you haven't tested it? You need to supply the end user with validated procedures for sterilizing the device prior to use, yet you say that you haven't done any tests? If you state that the user has to 'clean with IP before sterilisation' you need to say how they should do it. A quick wipe? Full immersion for X minutes? etc etc.