Locations for environmental monitoring shall be chosen based on their likelihood of
indicating contamination or failure in contamination control systems.
Crucial to ensuring that critical areas are properly controlled for contamination risks.
๐๐๐๐ฝ๐ถ๐ฐ๐ฎ๐น๐น๐ ๐ต๐ถ๐ด๐ต
Focus on areas with high potential for microbial contamination, such as those near operators,
doors, and equipment.
Locations where atypically high or out-of-limits microbiological or particulate data were
collected in the validation of the area (during initial qualification).
The occurrence of microbiological contamination during “at rest” validation monitoring is
generally very low and therefore recourse should be made to data from particulate monitoring
done as part of validation according to ISO 14644-1.
๐๐๐๐ฎ๐ฆ๐ฎ๐ฅ๐๐ญ๐ข๐จ๐ง
Locations close to return air ducts where all microorganisms carried in the air stream may be
expected to pass before leaving the room
๐๐ฒ๐ฟ๐๐ผ๐ป๐ป๐ฒ๐น ๐ฎ๐ฐ๐๐ถ๐๐ถ๐๐
Locations where person are known to be required to work or intervene, Care should be taken
to ensure that the value of having data from monitoring these areas of personnel activity is
not outweighed by the risk of causing unnecessary contamination as a result of making the
work more difficult or by creating additional interventions.
๐๐ฒ๐ฟ๐๐ผ๐ป๐ป๐ฒ๐น ๐ญ๐ซ๐๐๐๐ข๐
Locations where personnel are known to be required frequently to pass through.typically
these include doorways
๐๐ถ๐ณ๐ณ๐ถ๐ฐ๐๐น๐ ๐๐ผ ๐ฐ๐น๐ฒ๐ฎ๐ป ๐น๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ป๐
- Locations which are known to be difficult to clean and/or disinfect properly.
- Typically these include gas off-take points, engineer’s tool boxes etc.
- List out the sample sites based on above rationale, where rationale list is not exhaustive and indicate the sites on the respective area layouts
- This rationale shall be made at the time of initial qualification for new or modified area to select the sampling sites.
- Environmental monitoring locations that help ensure product quality and safety in compliance with regulatory standards.
