RT Journal Article
SR Electronic
T1 Container/Closure Integrity of Parenteral Vials
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 145
OP 158
VO 41
IS 5
A1 Dana K. Morton
YR 1987
UL http://journal.pda.org/content/41/5/145.abstract
AB 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.