(a) If the cooling water flow rate in your heat exchange system is equal to or greater than 8,000 gal/min and is not meeting one or more of the conditions in § 63.104(a), then you must comply with one of the requirements specified in Table 8 to this subpart.

(b) For equipment that meets Current Good Manufacturing Practice (CGMP) requirements of 21 CFR part 211, you may use the physical integrity of the reactor as the surrogate indicator of heat exchanger system leaks when complying with Item 1.a in Table 8 to this subpart.

(c) Any reference to SSM provisions in other subparts that are referenced in paragraphs (a) and (b) of this section or Table 8 to this subpart do not apply.