Bioburden testing is performed on In-Process pharmaceutical products (or any non-sterile product) to quantify and identify micro contamination. The test is performed on a product sample prior to filtration, filling, and any final sterilization cycles. The test lets manufacturers know what types of organisms, and how many, are getting into the product before they’re physically removed or killed off. If they’re physically moved or killed off, why do we need to know if they’re in the product at that stage? Great question!
Bioburden testing is pretty straight forward:
There are other methods, but this was used for the product I talk about in the unfiltered story. It was the preferred method in the lab at the time. We could test large volumes, as opposed to the pour plate where we could only do 1mL a plate.
But how do we know microbes in the product will show up during this test? The drug may prevent the organism from growing or could even kill the microbes we’re looking for. That may not seem like a big deal – “the drug kills organisms, so we don’t have to worry so much about removing them!”. But re-read the bullet points and you’ll remember why we need to know if organisms were ever there. Back to the question- we know the test works because we validate it. We inoculate a sample with target organisms, test it, then confirm recovering those organisms after incubation. If we do this over multiple lots and recover about as many organisms as we inoculated, we consider the method validated. Other testing kinks get worked out during the validation too. What type of rinse too use, how much rinse, the material in the filter, etc… Hopefully this background helps you understand the test so you can relate to the problem we had. Let’s get you back to the investigation story!
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