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.

Microbial Environmental Monitoring Software

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

Features of AmpleLogic Environment Monitoring Software

  • Methods and Area Limits provide automatic alerts if the outcomes exceed the limits
  • Limits for alert, action, and guideline are defined for certain areas and techniques
  • Each module keeps track of the type of media used and the results of visual inspections
  • It stores information about incubations such as the incubation ID, the incubation condition, the start, and end dates
  • It enables the recording of observations such as left and right finger dabs, aseptic activity, and acceptable limits
  • Observations of atypical and fungal colonies are documented with observer and checker remarks
  • Details about the excursion, such as the date of sampling exposure, the area, and any other comments, can be included
  • Users may keep track of their daily operations using the calendar function

Benefits of the Automated Microbiological Environmental Monitoring Software 

  • AmpleLogic Environmental Monitoring Module ensures that the Microbiological Sampling Plan is followed
  • It aids in the microbiological management of cleanrooms through appropriate recovery efficiency tracking
  • The auto alert system assists in tracking and adhering to the sampling frequency and locations specified in the standard operating procedures
  • The Settle Plate Excursion Report assists in tracking daily excursion
  • Contamination sources may be tracked easily appropriately
  • Keeping track of observations by date and grade, as well as using filters such as room number, plate number, grade, area, quarter, and month enables careful monitoring of settle plate exposure to yeast and mold, as well as microbial sample
  • The auto warning method aids in avoiding schedule slippage, resulting in fewer negative remarks during regulatory audits
  • The EMS Software uses the Settle Plates equipment such as shelf life
  • It assists in ensuring that the appropriate cleanroom measures are maintained, depending on the enormous number of data
  • The Automated Microbiological Environmental Monitoring Software complies with 21 CFR PART 11 and EU Annex 11 requirements

Please contact the AmpleLogic Team if you would like to explore how the AmpleLogic Environmental Monitoring Software can benefit your organization.

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