Ampule and Vial Filling Machine

To describe the validation guideline for the ampule and vial hlling machine to be free from contamination during the hlling cycle 

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. 

The particle load should be examined at the location near the filling points with a particle counter. 

Particle Contamination of Ampules and Vials during Filling Procedure 

Ampules and vials should be filled with water for injection and afterward be inspected on the contamination with particles (particle classes 10 pm and 25 pm). The inspection can be performed with a particle counter. 

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