Filling Machine Speed and Fill Volume Validation


I am working in the sterile industry for parenteral injectables. Has anyone had any experience with the validation of fill volumes on filling machines ? Many parameters are to be considered (such as piston size, media, volume targets). We have also considered machine speed as a parameters and are hence validating the fill volume for maximum and minimum speed for a specific piston set.

But preliminary data analysis shows that the speed doesn’t seem to have any effect on the fill volume. We are considering to remove this parameter in our validation methodology because is takes twice the time to validate maximum and minimum speed.

Does anyone have any insight on the subject ? Have you had any experience of speed influencing the fill volume for vial fillers ?

Tanks for the input :slight_smile:

Usually the manufacturer should provide technical report regarding the filling specifications. In this report you may have also the optimal filling curve considering the physical properties of your liquid such as viscosity and density.
I have qualified the dosing function of a filling machine but I did it at 100% of the nominal production speed. We made some trials at lower speed for certain samples but no qualification. I remember in some cases we had out of spec at the lower speed, but we did not investigate further.

Thank you for the insight ! I will contact the manufacturer and see if he can provide such technical reports.

According to annex 15 of EU GMP you have to test to confirm upper and lower operating limits, and/or worst case conditions.

ALso remember you are not only qualifying the ability of the machine to maintain correct fill volume/weights. For aseptic operations you are also qualifying the ability of the process to maintain sterility. A slow speed means that each unit is being filled longer and has longer “time/opportunity” to become contaminated. Also a slow speed likely means that the entire fill time is longer for the whole run, which also adds to contamination possibility.

Alternatively, a fast speed can also be causes for contamination, because more spills are often present when you run faster, and possibly more air particulates can be generated.

So for many reasons you will need to run the filler at a range of speeds (and fill times).