Performance Qualification of a Vial Washer

A vial washer is a relatively simple machine commonly used to clean containers during the manufacture of dosage form drugs. Some drug manufacturers o­nly perform Installation Qualification (IQ) and Operational Qualification (OQ) of the machine as no regulatory requirements clearly state that the performance of the vial washer should be qualified. Although depyrogenation may be achieved using a heating tunnel or oven, if the washing process cannot remove chemical contaminants or particles, they will produce a pyretic response in humans or animals, although there are no pyrogens present. Some drug manufacturers may perform a qualitative trace study for coloring matter in washed vials using a white wiper to verify the performance of the washer, but it is not a quantitative method to reflect the actual performance of the washer for particles, endotoxin, and chemical contaminants.

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Author(s):

Lu Liqiang.

Journal:

Journal of Validation Technology Volume 8 Number 2 February 2002 .