Medical Device Manufacturing Environmental Requirements

M

medguy123

#1
I am part of a med device startup company which is producing a new class 2 product. We are in the process of mfg devices to be used for biocompatibility and animal testing. We are temporarily manufacturing these in a garage, literally, until we find a permanent location. We have a quality system in place, and outsource sterilization and packaging. Provided we pass our sterilization validation, what concerns would you have and what precautions you would recommend?

Thank you.
 
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Ajit Basrur

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#2
I am part of a med device startup company which is producing a new class 2 product. We are in the process of mfg devices to be used for biocompatibility and animal testing. We are temporarily manufacturing these in a garage, literally, until we find a permanent location. We have a quality system in place, and outsource sterilization and packaging. Provided we pass our sterilization validation, what concerns would you have and what precautions you would recommend?

Thank you.
Welcome to the Cove, medguy123 :bigwave:

21 CFR Part 820.140 on Handling states -

Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.

In accordance with above, your manufacturing environment must be controlled to be prevent microbial population as it contributes to the overall microbial load and thus impacts the sterilization cycle.

Since you have mentioned that your manufacturing environment is like a garage, there could be lot of challenges meeting this requirement. All medical devices that are sterilized need to have environmental monitoring program of the manufacturing environments.
 
M

medguy123

#3
Thank you for the quick reply. I do not believe it would be difficult for us to establish an environmental monitoring program. However, like the rest of 21CFR, it is left to the manufacturer to determine what is appropriate. I have come across a number of bioburden testing programs. It seems the standard methods involve air, surface sampling, or both and the monitoring can be qualitative or quantitative. I would be interested in hearing what methods people have used and how "acceptable" levels were established at their company.

Thanks!
 
M

MIREGMGR

#4
Most FDA regulations are written in outcome format, i.e. if you can make devices in a garage that are suitable for their intended use, that's OK.

Obviously you can't finally validate production processes in a totally different environment than where they eventually will be conducted. You probably can't establish that the environment in the garage is stable, therefore you probably will have to verify bioburden on every manufacturing batch, or every production unit depending on product type, so as to establish that it is low enough to be within the validated capability of the sterilization facility and cycle that your contractor will use; and, that sterilization cycle may need to be rigorous in an overkill direction to suitably assure that the imperfectly managed bioburden is adequately dealt with.
 
M

MIREGMGR

#5
I have come across a number of bioburden testing programs. It seems the standard methods involve air, surface sampling, or both and the monitoring can be qualitative or quantitative. I would be interested in hearing what methods people have used and how "acceptable" levels were established at their company.
All of the bioburden management programs with which I'm familiar, are based on preparatory work to make the managed environment stable and consistent, and unaffected by the activities taking place in it and at its defined boundaries, i.e. goods and people moving in and out. A normal garage is a long, long way from a stable, consistent bioburden environment. I think instead you're going to have to verify bioburden on your actual devices after they leave the uncontrolled manufacturing environment.

Of course, I don't know what your devices are, so the above is a generalization.
 
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