We have eye drop line.
Process flow are Manufacturing tank -> pipe -> buffer tank with mixer(service tank) -> filling Machine.
We have plan change of buffer tank(30L -> 100L),we don`t have change pipe, only replace beffer tank.
we will qualification(includ CIP/SIP) and medis fill test…
I have a question. Should we do Process Validaion of all eye drop procuct?
May I have your opinion ?
Yes. By increasing the size of the buffer tank you are increasing the lot size not to mention the head pressure to the mixer.
In addition the tank should be commissioned and qualified. The lot of drug product manufactured using this tank should be put on stability and cleaning validation confirmed.
Sounds like somebody (a genius) in engineering instituted this ‘notifiilable change’ without thinking about the implications!
Also, be sure the stir shaft intrudes into the new larger tank at the same ratio as before.