Microbiology laboratory commissioned
Ergopharm has commissioned its microbiology laboratory, bringing sterility, bioburden, endotoxin and environmental monitoring testing in-house under its own quality system.
Microbiological testing has a property chemical testing does not: the laboratory itself is a contamination risk to its own results. A false positive from laboratory contamination is as damaging as a missed true positive, because it triggers an investigation, a possible batch rejection and a supply consequence, all from an error in the room where the test was done.
“In microbiology, the laboratory can create the very result it is there to detect.”
The laboratory is therefore laid out with the same logic as a production cleanroom — separated flows, controlled entry, a dedicated area for sterility testing under unidirectional airflow, and negative-pressure handling for anything grown. Media is growth-promotion tested before use, and every incubator is mapped and monitored.
Environmental monitoring of the production areas is run from here, which puts the people who read the plates in the same organisation as the people who set the limits — and keeps both independent of production.
Key facts
- Scope
- Sterility, bioburden, endotoxin, environmental monitoring
- Layout
- Separated flows; sterility testing under unidirectional airflow
- Media
- Growth-promotion tested before use
- Incubators
- Temperature mapped and continuously monitored