Dear Rishabh,
What sizes of bottles do you have for filling? What is your maximum bottle capacity and what is the minimum bottle capacity?
I would suggest you to carry out the PQ of bottle filling machine using the maximum and minimum filling bottle. You can also do one intermediate filling bottle for your records.
Regards,
Abhishek
Rishabh from a practical stand point things to consider.
If the machine can adjust to variable size containers and regulate the feed and fill rates 'preferably automatically' then you may get away with it, but remember Murphy is your 'best friend' in quality.
Variables that you might want to take into consideration might be:
- The shape of the new bottle (height and diameter)
- The bottle feeder (size, speed, line up)
- The bottle filler (the movement tolerance, the filling speed, method of 'full' detection)
- Will the line switch between 50ml and 100ml containers? Switching time.
When in doubt about doing PQA or not, "Are you prepared to risk putting your neck, by clearing something that has not been verified to work?" (Old mentor passed this concept down.)
not necessary, higher capacity is required to plan for future expansion only.
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