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!