Vials must be spiked with 70μm, 100μm and 400μm particles and to be tested.
Minimum 30 to 32 times each vial must be tested to have accuracy.
The parameters to control on an automated system is :
[COLOR=“blue”]Spin Speed: The speed at which vial is spin before inspection
Sensitivity of electric signal that differentiates signal from Noise
Light intensity that illuminates the container.
Inspection view hieght : The hieght of inspection window starting from base of the vial over which the data is collected by sensors.[/color]
In addition to machine settings and formulation properties, fill configuration of the final drug product presentation (i.e., size and shape of container and liquid fill volume) plays a significant role in determining the performance of an inspection system.