Washing, Sterilizing, and Drying Machine for Stoppers

SUBJECT Washing, Sterilizing, and Drying Machine for Stoppers 

To provide the guideline for validation of the washing, sterilizing and drying machine for stoppers to meet the cGMP requirement 

It is the responsibility of the technical service and quality control managers to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

The number of stoppers should be chosen according to a total stopper-surface of 200 cm. Place the stoppers to be tested into a particle-fiee container with a pair of tweezers. Shake the stoppers for about 30 sec with a filtered and dilute detergent solution. Filter the obtained solution through a 0.45 rm filter, as reference. Repeat the same procedure without stoppers. 

Perform the test and reference test three times. Inspect the filter afterwards visually, using microscope using lateral incident light with an enlargement of 40x. 

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