Currently I am qualifying a syringe filling application for a pilot plant.
The part within the qualification which I am not familiar with, is the visual inspection.
All inspections (vials) within the pilot plant are executed manually.
I know that we need an inspection procedure, test kit and a training.
But where can I find a set/overview of defects on which I can base the procedure and the test kit? Does anyone know if these test kits are available in the market?
Thank you for the interesting replies!
During Vial inspections you can perform following things and reject vials based on:
-Vial non comformances
-Capping non conformances
-Volume Non-Conformaces/ Dry solid non conformances
-Particulates- White, Glass pieces, Black, Fibres etc
You can actually get your folks trained by introducing 40,70 & 100 MICRON particulate beads into the Glass vials and get them regularly tested by mixing randomly in good lot of vials.
In one of the blogs here we have written about KNAPP TEST for visible inspection of Vials. Please train all your operators with this methods manually using Black and white boards.
Every day you must train atleast 5 people each shift for 4 hours. That means at the end of month you will have 10 trained staff. The training must be atleast for 90 hours normally to get a grip on Inspection procedures, speeds and removal methods and quantification of the same.
You can remove non conformacies of vials based up on Technical report given by PDA:
Technical Report No 43: Identification and classification of Non conformancies in Molded Tubular Glass containers for Pharmaceutical Manufacturing.
You can get various details regarding Vial visual inspections in PDA book store. This is so far the best place for the purpose you are looking.
Regards