Knapp test again

Hi all,

I have some question about semiautomatic inspection when you qualify the equipment, nor the inspection process: could you please answer me just with yes or no? Of course it would be fine your explanation after that ;), It is only because I’m trying to avoid misunderstandins due to the language.

  • Is it mandatory to do a knapp test during OQ to determine speed parameters? and once you have determine speed?
  • When you do knapp test and you talk about reject vials, are you talking about all type of defects (spots, cracks, etc) or only about suspended particle matter?
  • The number of rejected vials to do the kit is fixed? Have it to be 70 rejected vials of the same format and 280 good vials?

Thanks in advance!