Hi,
I am enquiring for a procedure for spiking studies for Visual Inspection? Would i have to perform various spiking studies to establish the correct lighting, viewing angle & viewing distance from surface? I would appreaciate any feedback as i’m unclear to the approach to take in carrying out spiking studies
Regards
Sinead
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.
Hi Durga,
Sorry if my previous question wasnt clear but i was enquiring about spiking studies for visual inspection of equipment after cleaning.
Regards
Sinead
Actually, you needed to mimic the conditions of manufacturing environment for lighting, distance and angle. I would say 45 and 90 degree for viewing angle, calculate light intensity, viewing distance could be distance btw personnel and inspection surface (usually prefer 3m, 10m and largest equipment you have in train).