1. Introduction
Container closure integrity (CCI) is the ability of acontainer closure system to maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life. It is a regulatory requirement that the design of a container closure system b qualified. There are multiple methods available to qualify the effectiveness of a selected container closure system as detailed in industry guidance and literature. Selection of an appropriate method is based on the container closure system to be qualified and its contents. The norma variation within the manufacturing process should be taken into consideration when qualifying the integrity
of the closure system.
1. Introduction
Container closure integrity (CCI) is the ability of a
container closure system to maintain the sterility and
product quality of sterile final pharmaceutical, biological,
and vaccine products throughout their shelf-life.
It is a regulatory requirement that the design of a
container closure system be qualified. There are multiple
methods available to qualify the effectiveness of
a selected container closure system as detailed in
industry guidance and literature. Selection of an appropriate
method is based on the container closure
system to be qualified and its contents. The normal
variation within the manufacturing process should be
taken into consideration when qualifying the integrity
of the closure system.
While the regulatory expectations and industry standard
practices for initial CCI qualification are well
defined, the regulatory requirements with respect to
in-process or routine manufacturing remain unclear
with the exception of fused containers.
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