Environmental Monitoring
Aseptic processing and controlled environment are used in many applications in the Biopharmaceutical, Food and Beverages industries, as well as in Hospital/Pharmacy.
Because aseptic processing relies on the exclusion of microorganism from the performed operation and the prevention of exogenous microbial contamination, a good environmental monitoring program is one of the most important laboratory controls. This program provides meaningful information on the environmental trends of clean areas allowing the implementation of corrective actions before contamination occurs. Environmental monitoring programs, when appropriate, should include quantification of microbial content of room air, compressed gases, and surfaces (equipments, floors, walls, protective garments, etc.).
Written procedures should be clearly defined including a list of critical locations to be sampled as well as sufficient details to allow reproducible sampling such as sample timing, sampling duration, sample sizes and frequency. Alert and action levels should be established and trend analysis for test result interpretation should be performed over an extended period by trained personnel.
Low level contamination can be particularly difficult to detect. Sample sizes should be sufficient to optimize detection of environmental contaminants at levels that might be expected in a given clean area.
As microbial environmental monitoring is also used to assess the effectiveness of cleaning and sanitization procedures, sanitizing agents may remain in the test system, therefore media with additives (neutralizing agents) may be used.
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