Aseptic process simulation( from China)

GOOD VALIDATION PRACTICE (cGVP)
1

Hi everyone
i am encountering a problem on media fill. i have read two article with regard to it. there are seveal difference and puzzle on them. could somebody help me kindly?

  1. how many vials shall we fill? my batch size is 80,000 vials, do we need to do the full batch size for 3 times?
  2. we have 4 freeze dryer following the filling line, once we get 80,000 vilas filled, we fill them into one freeze dryer as one batch, for sure, freeze dryers are included in media fill, do we need to fill 80,000 vials for each freeze dryer, that is nightmare for every company. could some body give some comments on alternatives.
  3. i found two different acceptance criteria from European GMP and PIC/S, the former is 10 times more rigorous. we are confused about which way we should follow.

i am working for a company which is engaging the first international vaccine project in China, pleae give me your answer, thank you all.

2

Hi, the ISO 13408-1 can help you. We have a similar process and I take yhe AC from this St

Best regards

javier

3

Perform the media fill validation with minimum of 5000 vials and simulate the filling period with 80000 vials(i.e fill 5000 vials in a time required to fill 80000 vials). performs the all interventions in filling period such as machine parts changing, environmental monitoring and power breakdown as worst case condition during media fill.
Lyophilization process can be simulated only for time at ambient temp.
contamination rate should not be more that 0.1% calculated with upper 95% confidence limit

Rate = Upper 95% confidence limit * 100/ no. of filled vials