Environmental Monitoring

Environmental Monitoring (E/M) program is designed for demonstration of the control of viable (living microorganisms) and non-viable particles in critical areas including  clean-rooms, isolators, biological safety hoods, laminar flow hoods, molding machines, glove boxes, and kit assembly lines. The environmental monitoring program is one of the most important laboratory controls in aseptic processing and a requirement of all Good Manufacturing Practices. Environmental monitoring can provide useful information on the quality of the aseptic processing environment and the trends of ancillary clean areas.

Our Environmental Monitoring Service

• Develop Environmental Monitoring Protocol

  The protocol includes frequency of sampling, when the samples are taken (ie, during or at the conclusion of operations), duration of sampling, sample size (eg, surface area, air volume), specific sampling equipment and techniques, alert and action levels, and appropriate response to deviations from alert or action levels.

• Sampling for Environmental Monitoring

  Surface sampling, for example, should be done by agar transfer, if possible, while air sampling can be performed in a variety of ways.

• Viable Environmental Monitoring
  • Monitoring of personnel, air and area surfaces for microbial contamination caused by bacteria, yeast and mold, including four tests: volumetric sampling, settle plates, contact plates, and finger dabs;
  • Identification of genus and species with gram staining and MALDI-TOF;
  • Establishment of action and alert limits with analysis of microbial trends.

  Once the samples arrive at our lab, they are incubated and enumerated. The total count may be expressed in several different ways depending on the type of sample and sponsor preference. Examples include: colony-forming units (CFU)/plate, CFU/filter, CFU/m3, or CFU/cm2.

Fig. 1 WHO recommended limits for microorganisms in clean room. (World Health Organization, 2012)

• Non-viable Environmental Monitoring with Active Methods
  • Measurement of particulate with laser counter

Fig. 2  Maximum permitted airborne particulate concentration per air grade in clean room. (Good Manufacturing Practice, 2009)

• Gowning Qualification
• Disinfectant Qualification
• Glove Fingertip Testing
• Compressed Gas/Air System Testing
• Microbiological and Chemical Testing for Water
• Temperature and Relative Humidity Testing and Mapping
• Lighting Level
• Trend Analysis of Environmental Monitoring Data

The Benefit of Environmental Monitoring

The environmental monitoring service offered by STEMart can

• Identify potential routes of contamination promptly;
• Provide a measure of the state of control underpinning the pharmacy’s operations;
• Reduce the risk to products and possible sterilization failures;
• Allow the implementation of corrections before the product contamination occurrence.

STEMart uses various industry-leading collection methods to meet customer sampling needs, and conducts environmental monitoring through methods that comply with ISO, USP and ASTM specifications. If you have additional questions about Environmental Monitoring Tests or would like to find out more about our services, please feel free to contact us.

References

• World Health Organization. "Environmental monitoring of clean rooms in vaccine manufacturing facilities." Switzerland 201.1: 27 (2012).
• Good Manufacturing Practice, Annex 1: Manufacture of Sterile Medicinal Products.  Bruxelles, Commission Européenne (2009).