[COLOR=“#0000CD”]Dear forum members,
I need help on micronizer cleaning validation…[our facility is multi product facility]
1.How batch size has to be considered?
2.Which equipments surface area has to be considered for establishing the swab limits? Either total chain of equipments or only micronizer followed by shifter.
3.Is it correct for following two type of limits for the same product, i.e, for micronizer followed by shifter one specification limit and other chain of equipments another specification limit, because we did not require micronized material every time.
4.Concurrent validation is acceptable for micronization?[/color]