The container closure system for pharmaceutical
products intended to be sterile is critical and this criticality relates to the
physical properties of the container closure system in that a poorly designed
or manufactured system will result in microbiological penetration. Factors to
take into account with, for example, rubber-stoppered glass vials include
having the correct dimensional specifications for the internal diameter of the
neck opening and its depth, the internal and external diameters of the flange.
Other factors are the concentricity of the flange, the neck and the body of the
vial. Any angularity of the flange versus the vertical center line of the vial
must be specified; so must the physical finish of the surface of the flange and
internal neck bore to ensure satisfactory mating with the closure. Closures
must be specified in terms of diameters, depth, thickness and elasticity.
This is the basis of a new article by Tim Sandle.
Tests to verify the container-closure can be grouped
as microbial tests or non-microbial (physical) tests. Physical tests include
the dye test; vacuum testing (typically leak testing with sensitivity to detect
leaks down to approximately 5-10 microns); gas leakage determined using a
bubble test; liquid leakage detected by atomic absorption of a copper ion
tracer solution; laser-based gas headspace analysis using a frequency
modulation spectroscopy; high voltage leak detection (which detects package
defects using an electrical current); or a helium leak rate test (which
quantitates the flow rate of helium from leaks in packaging after having been
flooded with helium as a tracer gas).
Where microbial tests are required, there are various
factors to consider. These form the basis of the paper.
Then reference is:
Posted by Dr. Tim Sandle
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