Environmental Monitoring –
All environmental parameters listed under para 3.1 to 3.10 shall be verified and established at the time of installation and thereafter monitored at periodic intervals.
The recommended frequencies of periodic monitoring shall be as follows:
( a ) Particulate monitoring in air – 6 Monthly
(b) HEPA filter integrity testing (smoke testing) – Yearly
(c) Air change rates – 6 monthly
(d) Air pressure differentials – Daily
(e) Temperature and humidity – Daily
(f) Microbiological monitoring by settle plates and/or swabs in aseptic areas – Daily, and at decreased frequency in other areas
Note: The above frequencies of monitoring shall be changed as per the requirements and load in individual cases.
