Bioburden numbers and ECA gloves



In a December Warning Letter published today, Customed (a Puerto Rico kit packer and sterilizer) was gigged for not requiring gloves as part of their ECA garb, even though apparently they were consistently achieving their bioburden numbers.

21CFR 820.70(d) requires controls if their lack could "reasonably be expected to have an adverse effect on product quality". My previous understanding has been that bioburden data are the proof of effect, and if one's bioburden numbers from all causes are consistent and good, then it is proven that whatever you're doing is sufficient and effective, and whatever you're not doing cannot be reasonably concluded to be having an adverse effect.

Apparently that's changed...?
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TWA - not the airline

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Interesting find. :applause:
The warning letter states "For example, your firm did not establish gowning requirements for the manufacture of finished product to minimize bioburden or particulate contamination of the device. Employees were observed assembling sterile and non-sterile convenience kits without gloves." That does not exactly mean that FDA now thinks that gloves are required. Maybe Customed did not have a gowning procedure or some employees did wear gloves while others did not and no one could explain why both would be acceptable. Also in the warning letter I do not find any reference to the fact that they did make their bioburden numbers (their response talks about a CAPA and unspecified additional controls they wanted to implement), so maybe their monitoring was too weak and they tried to argue that their gowning procedure prevents contamination but then this also was not sound enough.

My take still is, that you just need to have adequate controls, so I would still guess that if you have detailed requirements that were developed with a sound scientific rationale (e.g. consistent experience regarding bioburden) then you should be fine as long as your bioburden monitoring is stable. I would also guess that if you do not have such data, then using disposable gloves and ECA garb that is typically used for your clean room class would be considered acceptable controls based on the rationale that this prevents contamination.

I personally have mixed feelings about gloves compared to periodic hand disinfection as in the gloves there are perfect conditions for germs to proliferate. So maybe though you do not contaminate your product, there is a certain risk that you may contaminate your clean room. But then you also need to consider that small particles of dead skin are pyrogenic, so it is not only the bioburden you might need to control depending on the product.
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