Microbial Environmental Monitoring Software
An Environmental Monitoring (EM) program that ensures product safety during the drug production process is essential for pharmaceutical companies. A robust Environmental Procedure assists in identifying sources of contamination, particularly in aseptic environments.
Pharmaceutical firms have to observe Standard Operating Procedures (SOP’s) for environmental monitoring compliance with the regulatory standards of organizations such as the US Food and Drug Administration (US FDA) and MHRA.
Adopting manual procedures such as sampling mechanism, frequency, and location management is time-consuming, and any non-compliance challenges may result in audit observations. Process and microbiological evaluation in controlled environments like cleanrooms may be tracked with automated environment monitoring solution. Microbial Monitoring Solutions, on the other hand, aid in the monitoring of cleanroom contamination.
Environmental Monitoring in aseptic environments is often conducted using the following methods
- Settle Plate Method
- Settle Plate exposure for yeast and mold
- Surface Sampling
- Microbial Air Sampling
- Personnel Monitoring (Grade A and Grade B)
- Particle Counter
- Isolate identification, and nitrogen monitoring in compressed air
- Test for Total Viable Aerobic Count