In food/medical service

In food/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 that is a safety hazard;
(3) The intended reaction to be slowed down or stopped; or
(4) An undesired side reaction to occur.

Source

40 CFR § 65.2


Scoping language

All terms used in this part shall have the meaning given them in the Act and in this section. If a term is defined both in this section and in other parts that reference the use of this part, the term shall have the meaning given in this section for purposes of this part. If a term is not defined in the Act or in this section, the term shall have the meaning given in the referencing subpart for purposes of this part. The terms follow:

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