Environmental Monitoring (EM) plates are released after ensuring that the results are valid and comply with regulatory requirements.
*Fungal plates are incubated at 20–25°C for 72 hours, and bacterial transfer plates are incubated at 30–35°C for 48 hours.
*Examine the plates for microbial growth after the incubation period.
*Count and record the colony-forming units (CFU) present on each plate using a colony counter.
*For air sampler plate counting, count the colonies after incubation.
*The Feller correction is applied when counting microbial colonies on air sampler plates.
*Calculate CFU/m³ by dividing the number of colonies by the volume of air sampled.
*Differentiate between bacterial and fungal colonies, if applicable.
*Compare the CFU counts with the established alert and action limits for the monitored area.
*If the CFU counts exceed the action limits, identification of microorganisms may be required using biochemical or molecular methods.
*Document the types of organisms identified and ensure proper identification.
*Alert levels indicate potential issues, whereas action levels indicate a failure requiring investigation.
*If the counts exceed the action limits, initiate an investigation to identify the root cause and assess the impact on the environment or product.
*Document all deviations and investigations according to Good Documentation Practices (GDP).
*Ensure that all recorded data is accurate, complete, and verified.
*Conduct trend analysis, if required, to monitor environmental conditions over time.
*If all counts are within acceptable limits, the plates can be released, and the area or process can be cleared for continued use.
*If counts exceed the specified limits, additional measures such as cleaning, disinfection, fogging, and re-monitoring may be required before the area is cleared.
*Complete all relevant documentation, including logs, reports, and trending data.
*Submit the results for approval by Quality Assurance (QA) or other responsible personnel.
Once QA reviews and approves the results, the plates are officially released, and the area is
confirmed as being within control.