Scope
This paper aims to highlight best practice for Container Closure Integrity (CCI) testing of medicinal
products for parenteral use in the pharmaceutical industry. It should be seen as addition and
complementary to the monographs of the different Pharmacopoeias. CCI testing of medicinal products for
parenteral use should be used in order to ensure consistent product quality with regards to closure
system integrity.
Modifications from the procedures and figures proposed in this paper are possible at any time. However,
following the proposed procedures and figures may lead to safer CCI processes and may avoid
discussions in GMP audits and inspections, as the described approach reflects current practice and has
previously demonstrated its suitability for purpose during many years of industrial operation which
includes referring GMP inspections.
