In the context of microbiology, environmental monitoring involves collecting data regarding the identification and enumeration of microorganisms present in the air, on surfaces — and on personnel — in facilities engaged in activities that rely on the maintenance of sterility in clean rooms and other controlled environments. Monitoring enables facilities to identify and track trends related to sterility assurance.
EOC1 can manage your microbiological monitoring environmental program, from taking samples to reporting. This is an important distinction, which separates us from most other vendors of monitoring services. While our competitors may handle disparate segments of the overall process, we offer a comprehensive program of microbiological environmental monitoring services. A complete environmental monitoring program is comprised of numerous components, and includes sampling plans, active and passive sampling, microbiological monitoring of clean rooms, lab analysis, and reporting of data including trending.
In addition to non-viable particle testing in primary and secondary engineering controls, USP <797> mandates viable air and surface sampling for bacterial and fungal contamination in facilities compounding sterile preparations. Of course, this includes microbial monitoring of clean rooms. A successful USP <797> environmental monitoring (EM) program would include both air and surface sampling.
Viable air monitoring is used to measure the level of control a facility has over the airborne microbial load of that facility. Viable surface sampling is used to assess the ability of the facility’s cleaning processes to keep surfaces free from microbial contamination. Typically, microbial contamination is primarily due to human activities, so each of these environmental monitoring microbiology sampling programs will measure proper techniques and processes related to eliminating microbial load in the air and on surfaces.
Viable Air Sampling
Viable air sampling is an active sampling method using impaction that requires a high-volume air sampler at a sampling rate of at least 400L-1000L of air. USP <797> dictates the frequency of sampling as semi-annual. Environmental monitoring is non-specific so general growth media is used for bacteria and fungus. Air samples specific for bacterial will use a general media such as TSA (Tryptic Soy Agar) or soybean casein digest, while air samples specific to fungus will use media such as MEA (Maltose Extract Agar) or Sabouraud Dextrose Agar.
Viable Surface Sampling
EOC1 can manage your environmental program from taking samples to reporting. This is important as most other vendors only handle parts of the process. An environmental monitoring program requires many parts and includes sampling plans, active and passive sampling, lab analysis and reporting of data including trending.
In addition to non-viable particle testing in primary and secondary engineering controls, viable air and surface sampling for bacterial and fungal contamination is required by USP <797> in facilities compounding sterile preparations. A successful environmental monitoring (EM) program would include both air and surface sampling. Viable air monitoring is used to measure the level of control a facility has on the airborne microbial load of a facility. Viable surface sampling is used to assess the facilities cleaning processes ability to keep surface free of microbial contamination. Since much of microbial contamination is due to human operations both sampling programs will measure proper technique and processes related to eliminating microbial load in the air and on surfaces.
Viable Air Sampling
Viable surface sampling is not an active method of sampling and uses special raised plates to take direct samples of a surface. Because surfaces can contain residue from cleaners, viable surface sampling plates must contain neutralizers, which are capable of neutralizing the cleaning chemicals used. A typical neutralizer would include lecithin and polysorbate 80, since it counteracts a wide range of cleaning agents.
EOC1 is an industry leader in controlled environments testing and certification services. Our extensive experience in microbiological monitoring helps ensure your ongoing regulatory compliance, while contributing significantly to reassurances regarding employees’ on-the-job safety.
In addition to these capabilities, EOC1 offers a wide range of other services to help customers meet pharmaceutical clean room qualification standards. As a leading provider of controlled environmental testing and certification for more than 14 years, we bring significant expertise to the table. We hold all the necessary credentials, and our extensive in-house resources make us the single source for any of your needs. Learn more about our other pharmacy compliance services here.