How are ranges of tablet press speeds handled in validation?

2 posts / 0 new
Last post
tbc
tbc's picture
How are ranges of tablet press speeds handled in validation?

How are ranges of operating parameters such as compressing forces and tablet press speeds handled in process validation? Are separate runs at high and low parameter extremes conducted to validate ranges of parameters? Or are multiple runs at the same parameter settings conducted to demonstrate repeatability? Any other options?

albridgeuk
albridgeuk's picture
hI

hI

You are required by the regulators to validate the speeds you intend to use.  The dynamics of these machines varies considerably with their operating speeds, so there is no way round the need to validate all the critical parameters for the chosen speeds.

regards
Bridge W