Manufacture of sterile preparations
Control particulate during operation
Monitoring during operation
Alert and action limits for particulate and micro
Action taken when exceeded
Area grades should be proven (e.g. validation runs, media fills, environment, time limits - based on microbiological contamination/bioburden found)
The manufacturer should control particulate matter during operation to prevent contamination of the product. Therefore, to assist and ensure control, monitoring during operation is necessary. As there are alert and action limits for particulate and micro defined by the manufacturer, the operators have to stop working in case the condition is out of limits.
Action should be taken when the limits are exceeded, e.g. cleaning and/or sanitization.
Area grades should be proven through qualification and validation (e.g. validation runs, media fills, environment, time limits). Limits should be based on microbiological contamination/bioburden found.