ABSTRACT
Package integrity, also called container-closure integrity, is the measure of a primary package’s ability to keep the product in (including vacuum or inert gas headspace, if present) and to keep potential microbial, particulate, and chemical contaminants out. Package integrity is a requirement that must be met throughout the product’s life cycle, beginning from early development phases. A variety of tests are available for use by the pharmaceutical industry to measure parenteral product-package integrity, although no one test can be recommended for all parenteral package integrity testing. Historically, microbial ingress tests were considered the definitive standard, although regulatory agencies increasingly prefer validated physical test methods less subject to variability. Container-closure integrity verification of all units in marketed product lots has become a reality for many dosage form packaging types.
