Container/Closure Integrity of Parenteral Vials

Parenteral products are frequently packaged in a system composed of a serum finish glass vial, an elastomeric closure, and an aluminum crimp seal. Factors which are critical to such a package’s integrity are described including package specifications, the absence of critical defects, the physical location at which the seal must occur, and the impact of environmental forces exerted on the assembled package. Leakage theory is discussed along with leak detection methodologies common to the pharmaceutical industry as well as to other disciplines. The legal implications of a nonintegral parenteral package are proposed in light of reported incidences of leakage in the healthcare and food industries.