Leaks

Section 218 Section 218.485  Leaks The owner or operator of a pharmaceutical manufacturing source shall repair any component from which a leak of VOL can be observed.  The repair shall be completed as soon as practicable but no later than 15 days after the leak is found.  If the leaking component cannot be repaired until the process unit is shut down, the leaking component must then be repaired before the unit is restarted.