Microbial Environmental Monitoring Software

Microbial Environmental Monitoring Software

It is imperative for Pharmaceutical Companies to have a well-defined Environmental Monitoring (EM) program, to ensure Product safety during the drug manufacturing process. A strong Environmental Procedure helps in identifying contamination sources, especially in the aseptic areas.

Pharmaceutical companies need to maintain Standard Operating Procedures (SOP’s) for environmental monitoring to comply with the guidelines given by the Regulatory Agencies like the US Food and Drug Administration (US FDA) and MHRA.

Following the manual procedure like sampling mechanism, frequency, and managing the locations is laborious, and any non-compliance issues lead to Audit Observations. An Automated Environment Monitoring Software helps to track the Process and Microbiological Evaluation of Controlled Environments like cleanrooms, etc. On the other hand, Microbial Monitoring Solutions helps to keep track of the Cleanroom Contamination.

The typical methods followed in the Environmental Monitoring in aseptic areas are:

  • Settle plate method
  • Settle plate Exposure for Yeast and Mold
  • Surface Sampling
  • Microbial Air Sampling
  • Personnel monitoring Grade A & Grade B
  • Particle Counter
  • Identification of Isolate and compressed Air Nitrogen Monitoring
  • Total Viable Aerobic Count Test

Key Features of AmpleLogic’s Environment Monitoring Software

  • Methods and Limits on Area helps in auto alerting in case of the results are deviating from the limits
  • Alert/Action/Guideline limits are mapped for selected areas and methods
  • Each module records the Type of Media used and Visual Inspection results
  • Incubation details like Incubation ID, Incubation condition, Start, and End dates
  • Allows capturing of observations like Finger Dab Left and Right, Aseptic Activity and the Acceptable Limits
  • Atypical and Fungal Colony Observations are also recorded with Observer and Checker Remarks
  • In case of Excursion, the details can be added. The excursion details include Date of Sampling Exposure, Area, and Remarks
  • The Calendar feature allows employees to track their day-to-day activities

Benefits of Automated Microbiological Environmental Monitoring Software

  • Ensures adherence to the Microbiological Sampling plan
  • Helps in microbial control of Cleanrooms with proper Recovery Efficiency tracking
  • Auto alert mechanism helps track and adhere to the sampling frequency, sampling locations, in compliance with the defined SOP
  • Excursion Report for Settle Plate helps in tracking day-wise excursions
  • Track contamination sources with ease and in right measures
  • Tracking observations date-wise and grade-wise along with filters like Room no., Plate no., Grade, Area, Quarter, and Month, helps closely monitor the Settle plate Exposure for Yeast and Mold, Microbial sampling, etc.
  • Auto alert mechanism helps to avoid the Schedule slippage, thus fewer observations during regulatory Audits
  • Usages of the Settle Plates like Shelf life etc., Equipment’s and Instruments
  • Helps maintain the right measures cleanroom wise, based on the large volumes of the data
  • Compliant with 21 CFR PART 11 and EU Annex 11

If you would like to discuss how the AmpleLogic Environmental Monitoring Software can help in your business, kindly contact AmpleLogic Team