Bioburden requirements for Procedure Packs under Article 22?

Jonathanlai928

Starting to get Involved
Hi all,

We are procedure pack manufacturers where we assemble CE marked devices and package then sterilise. What are the requirements for Bioburden Testing? Is it enough to collate data from suppliers or is it required we have an in-house method?
 

planB

Super Moderator
You may want to work through ISO 11737-1:2018/Amd1:2021 for requirements that potentially apply to you.

Microbial data from suppliers might represent your final product in case you do not alter its microbiological characteristics during assembly. Bioburden-testing requirements are also driven by the method of terminal sterilisation you are going to apply, as well as risk assessment activities.

HTH,
 

Jonathanlai928

Starting to get Involved
Thank you kindly for your reply. I will reread 11737. We use the over kill method w/ethylene oxide. Perhaps a risk assessment can suffice, not sure. Still trying to understand what we are required to do with bioburden as we have thousands of components which are selected and then go into our packs.
 

planB

Super Moderator
You may want to account in your risk assessment for
- potential bioburden variations introduced by your suppliers (over different seasons),
- potential bioburden variations introduced by your manufactring steps,
- potential bioburden variations introduced by the sheer number of components and potentially differing procedure pack configurations,

to determine sample size and test frequency.

Presuming that you are following ISO 11135:2015, Annex B, half-cycle overkill approach employing a reference microorganism, this (conservate) sterilization valdation will offer you some flexibility in setting bioburden limits.

You may also want to consider grouping your components into families according to ISO 11135, section D.12.5.11.1, that are represented by worst-case members in terms of bioburden, thus reducing the numbers of components you want to have tested.

In case your components contact blood, you may also want to assess/test the levels of bacterial endotoxins.

HTH,
 
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