Hi Anon.
Microbial issues are always a little difficult to comment on because the situation is routinely one where the actual answer is going to end up being "it depends". Let's look at this logically - without more information about your particular situation (especially product, intended use, type of body area involved [especially if there is any sort of damage to the body's barrier systems like skin], etc.) the answer you come to will likely be a lot different. For example, if this is an electrode for measuring electrical activity being used on intact skin and only on intact skin you probably could argue that the bioburden testing could be more "optional" in that you might be able to do "surveillance" monitoring of the bioburden once you have good understanding of the material and the manufacturing processes. On the other hand, if this is a syringe that is being filled with injectables, I would argue you will never be able to logically argue that the bioburden is unnecessary to test on a regular basis.
This typically all comes down to realistic risk assessments and the potential for a device to "transfer" or "transmit" the organisms from the device to the patient on whom the device is being used. It also may be a situational thing - e.g., a device that is ultimately sterilized as part of the final production process might be logically argued that bioburden again is less significant than something that is being used exactly as the device was produced with no extraneous steps to eliminate the organism load on the device.
My suggestion - get in contact with a qualified industrial microbiologist who will understand what you are trying to accomplish and what your likely rates of failure might be and let them help you determine what testing, what frequency of testing and how low a limit of detection is necessary to get there. My opinion, as someone who was in a microbiology lab for 10 years before I moved fully into regulatory, would be generally you should look to the guidance and understand why the guidance is pushing the testing. And also, understand when the guidance doesn't make sense in your particular situation. Unfortunately, without someone with some expertise in the science itself you are going to have a hard time doing that analysis. Also, you need to remember - unlike chemical assays and testing, microbiological contamination is typically a "point in time; point in space" test meaning that your results will be dictated by several outside factors including the distribution of the organisms on the materials which often will be anything but "normalized" so it is very possible to find a "slug" contaminant. This means that you find the problem in a specific segment or section of the material but find absolutely nothing in the rest of the shipment. This can be uncomfortable but you need to consider how you manage these situations - which again argues specifically for the use of a qualified consultant to assist you and your management in determining the best next steps in any action plans.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 01-May-2023 00:39
From: Anonymous Member
Subject: Bio burden on non sterile device constituent component of combination product
This message was posted by a user wishing to remain anonymous
USP 1115 and several recent FDA guidances such as MDI and DPI guidance and cGMP guidance for combination products along with ISO11737-1 indicate that a manufacturer should monitor bioburden for a device constituent component (co-packaged) that is provided nonsterile. Is there any scenario where bioburden at least a baseline measurement should NOT be performed?
thank you