Ampule and Vial Washing Machine

To describe the procedure for validation of an ampule and vial washing machine to maintain microbiological quality 

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

Wash ampule and vials using different available washing programs. Determine the efficiency of the process by comparing the quantity of present sticking particles (particle size classes 50 pm and 2 to 50 pm) prior to and after washing the glassware. 

Fill washed and dried glassware with sterile filtered water, sonicate for 5 minutes and test with a particle counter. 

Microbiological Quality of Water Used for Glassware Washing 4.1 Recirculating water 

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Test the water used for prewashing in ampule and vial washing machine for viable count. 

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