Microbiological Environmental Monitoring
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 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
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.