Ampule Crack Detection Machine

To describe the procedure for validation of the ampule crack detection machine to meet the specification other machines available shall be validated accordingly. 

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

MiK 50 ampules rejected by the dye vacuum with 50 accepted ampules to produce a calibration set. Each calibration set should contain a representative sample of ampules with different sizes of holes and cracks as shown by the intensity of the dye in the ampule. Number the bad ampules on the base depending on the intensity of the dye, from 1 to 50. 

Pass the ampule sets through the machine at the manufacturer-recommended setting. 

All ampules rejected by the dye-vacuum method must also be rejected on the ampule crack detection machine. 

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The crack detection machine shall recognize more bad ampules than the dye-vacuum method and shall reject an equivalent number of good ampules as the dye-vacuum method. 

To determine the effect of wet or dry product on the outside of the ampule, select 100 good ampules and pass through the machine. The ampules are then wetted (with water) and passed through the machine again. Rewet the ampules (with product solution) allow solution to dry on the outside of the ampules. Pass the ampules again through the crack detection machine. 

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