Particulate count

Production
1

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

2

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?

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