Sir,
I am associated with environmental control of Pharma Industry. Our Drug authority did not mention the Class of cleanliness of proceess rooms for Oral Solid Dosage. Only they have asked for supply of 5 micron filtered air with 20 air changes per hour.
Now, they are asking integrity test of...
Sir,
Our drug authority have advised to put 5 micron filter in supply line of AHU of process rooms. Now they are asking for integrity test of 5 micron filters & particle count of the rooms.
What standard or process should I follow?
Please clarify & oblige