Oversight of the aseptic operations, environmental monitoring activity – for viable particle count (VPC) and Non-Viable particle count (NVPC). 

Sampling, testing, evaluation and interpretation of environmental monitoring VPC, NVPC, PEP and utility monitoring (nitrogen gas, compressed air, CO2 gas) results. 

To review trend for viable and non-viable monitoring data and suggest action if any. 

To review trend of microbiological monitoring of personnel of aseptic area. 

To train the personnel entering the aseptic area, qualify, disqualify the personnel for aseptic area entry.