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.
𝐀𝘁𝘆𝗽𝗶𝗰𝗮𝗹𝗹𝘆 𝗵𝗶𝗴𝗵
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.
𝐀𝐜𝐜𝐮𝐦𝐮𝐥𝐚𝐭𝐢𝐨𝐧
Locations close to return air ducts where all microorganisms carried in the air stream may be
expected to pass before leaving the room
𝐏𝗲𝗿𝘀𝗼𝗻𝗻𝗲𝗹 𝗮𝗰𝘁𝗶𝘃𝗶𝘁𝘆
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.
𝐏𝗲𝗿𝘀𝗼𝗻𝗻𝗲𝗹 𝐭𝐫𝐚𝐟𝐟𝐢𝐜
Locations where personnel are known to be required frequently to pass through.typically
these include doorways
𝐃𝗶𝗳𝗳𝗶𝗰𝘂𝗹𝘁 𝘁𝗼 𝗰𝗹𝗲𝗮𝗻 𝗹𝗼𝗰𝗮𝘁𝗶𝗼𝗻𝘀
- 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.