Automatic visual inspection - Bracketing

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hi there,

I’m currently trying to validate an automated inspection machine for small volume parenteral (SVP).

As far as I have read bracketing is possible but I can’t figure out the best way to do it.

We will have products that differ in the following parameters:
• Presentation (1mL, 5mL, etc)
• Color of the ampoules (transparent and amber)
• Marks on the ampoules;
• Descriptions (product color and turbidity);
• Viscosity (maybe);
• Conductivity (maybe)

Since I’ll have a different equipment recipe for each condition, is it necessary to validate every single one or which is the best approach to define a “worst-case”?

Thanks in advance!

2

Anyone with experience in automated visual inspection?

3

Dear concern.

First have you qualified automatic inspection machine by which method ?
I think best method for knapp test for 1 ml to 10 ml amps. Size.
First prepared challenge kit for individual size of ampls