Particulate count

Hello Sir,
what main Root Causes for particulate count raising out of limit under LAF filling machine in sterile Area out

Question is what is happening in your filling machine/under LAF at the time the out of spec occurs? Operator intervention? Malfunctioning equipment generating particles?

  1. Any intervention near machine.
  2. Check LAF performance.
  3. Contamination by machine or man or product