Simulated product for bioburden testing


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Hi all!

I'm looking for your help on defining a simulated product for bioburden testing of vd max 25 method as described in EN ISO 11137-2. Since the final product is very expensive consisting of several components, I'm trying to find a solution where the bioburden sample would be simpler, but still fulfill the criteria of the standard.

With the current proposed bioburden sample, all processes and materials and size are considered but the surface area is somewhat smaller. Do you think this would be an issue? Or, is there another suggestion for determining the bioburden for a complex device?

In a case, where a simulated product is used for initial bioburden determination, how is the biourden level tested later during production; with the actual product or with the simulated product?

Thank you already in advance for you input on this!


If the product has a claim of sterility for part of the product, you could perform bioburden testing on that portion of the product only.

If this route isn't feasible, I would recommend the Sample Item Portion (SIP) that is detailed in ISO 11137-2.

To answer your last question, Bioburden levels shall be tested on the actual product manufactured under similar conditions. From there you can determine whether the bioburden is evenly distributed on the item. If it is, you can establish your SIP from portions of the device that represent each of the materials from which the product is made.
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