21 CFR 211.50 - Plumbing

What it says

Potable water must be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Drains must be of adequate size and, where connected directly to a sewer, must be provided with an air break or other mechanical device to prevent back-siphonage.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Backflow and back-siphonage are the main risks, since sewage or contaminated water could reach product or equipment.
• Drains in manufacturing areas need to be designed and maintained so they do not become a source of microbial contamination.
• Water quality also depends on the plumbing, so leaks, dead legs and loss of pressure matter.

What FDA inspectors look for

• Whether potable water is supplied under continuous positive pressure.
• Whether drains have air breaks or equivalent protection.
• Whether leaks or standing water are present near product or equipment.

Related regulations