Integrity Testing of Vial Closure Systems Used for Parenteral Products

Abstract

Vial closure systems for sterile parenteral products must provide adequate protection against external contamination during the lifetime of products on the market. Two approaches are suggested for evaluating the adequacy of vial closure systems: (a) physical testing of the closure seal by use of a leak test, and (b) monitoring the ability of the container closure system to prevent microbial contamination. Leak testing of products helps to establish the integrity of the systems at the time of sealing. It also provides information concerning adverse product/closure interactions and continued integrity of the packages throughout the assigned shelf lives. Monitoring vial contents for sterility is accomplished by filling vials with a microbiological growth medium and inspecting them for microbial growth at intervals throughout the assigned shelf lives. At periodic intervals the container closure systems are challenged with an aqueous suspension of microorganisms.