In food and medical service

In food and medical service means that a piece of equipment in regulated material service contacts a process stream used to manufacture a Food and Drug Administration regulated product where leakage of a barrier fluid into the process stream would cause any of the following:
(1) A dilution of product quality so that the product would not meet written specifications,
(2) An exothermic reaction which is a safety hazard,
(3) The intended reaction to be slowed down or stopped, or
(4) An undesired side reaction to occur.


40 CFR § 63.1020

Scoping language

All terms used in this part shall have the meaning given them in the Act and in this section.

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