Performance Qualification On A Glass Vials Washer

GOOD VALIDATION PRACTICE (cGVP)
1

Dear all, we are in the process of issuing a Performance Qualification Protocol on a glass vials washing machine.

The tests decided to be included are the following:

  • Particles counting on 5 glass vials before entering the washing machine (i.e. the washing cycle)
  • Particles counting on 10 vials (beginning), 10 vials (middle) and 10 vials (end of the washing cycle)
  • Inocculation of 10 test vials with KCL as for a challenge test so that to pove abcense of Cl- at the end of the washing process.

We were considering to add also a fluorescence test by microspheres into 10 test vials for this reason.

However, do you know where we can purchase a relevant package. I think they are sold in the market in powder form (micro spheres). Do you know the concentration per vial? Do you know what ammount (i suppose in solution - ml) each vial shoud be added with? Should this ammount vary depending on each vial’s capacity?

We shall be using vials of 50, 100 and 250 ml capacity.

Thank you all.

Best regards,

2

One thing to be aware of is that with the cleanliness of current glassware, it is possible to have a higher particle count after washing than before washing. This doesn’t mean you shouldn’t do particle counts. It does mean that you need to be cautious in writing your acceptance criteria. Don’t use acceptance criteria around percent reduction in particulate unless you deliberately introduce particulate into the vials.