Cleaning validation


(Trí Nguyễn) #1

Hello,
Is it obligatory to make 3 batches for cleaning validation?

  • Need to make consecutively 3 batches?
  • For the highest worst-case product, may I conduct cleaning validation for 4th, 5th and 6th batch but not the 1st, 2nd and 3rd batch? (For some reasons)
  • With microbial limits, normally we need 7 days for the result, should we wait for 1st batch done so conduct the next batch or just making 3 batches and wait for all microbial limits result of them?

(Trí Nguyễn) #2

Can anyone give me some instructions ?