Sinks and Sanitation - 21 CFR Part 111

Anonymous16-2

Starting to get Involved
#1
Hello!

My question is in regards to the sinks required to wash and sanitize COP equipment.

Is there a regulation that states what type/kind of sink is required for Sanitation Rooms/Wash Rooms? Drainage? If a triple compartment sink is used, is there a regulation for that? Can someone point me in the right direction of where I can find this? Are there any recommendations for sink to do COP?

We manufacture Dietary Supplements and follow 21 CFR 111.

TIA
 
Elsmar Forum Sponsor

blackholequasar

The Cheerful Diabetic
#4
Sec. 111.27 What requirements apply to the equipment and utensils that you use?

(a) You must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained.


I believe that you validate this yourself and prove efficacy that the sinks do not cause any reaction with supplements or contamination. Most of the time they are stainless steel, right? I think you can probably quote an industry standard. Though, it's been a while since I've dug around this part. Perhaps @Watchcat may have more light to shed since she's the most FDA-knowledgeable person I know haha
 
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