A cleanroom or a clean zone is a critical application area in pharmaceutical industries, healthcare, microelectronic companies, among many other industries. Clean zones allow for the aseptic manufacture or processing in a microbe-free environment. Cleanroom monitoring, therefore, becomes essential since maintaining the environment sterile is key to all production undertaken in a cleanroom.
Clean Room Monitoring
All environmental conditions within a cleanroom can easily compromise the production quality of sensitive materials. Clean zones have restricted airflow since air contamination is a considerable risk. However, human contamination is by far the most critical source of contamination in a cleanroom. To effectively monitor a clean room, risk assessment is performed to review the effect all parameters introduced into the cleanroom would have on the final product or process. Clean rooms are classified periodically based on the risk assessment of each application.
Microbiological Tests Employed in Clean Room Monitoring
As mentioned earlier, humans are the main source of contamination in all clean zones. Humans would contaminate this area through endogenous emissions or errors following poor hygiene.
Microbiological tests that may be utilized in cleanroom monitoring include microbiological air purity tests on the human personnel, the interior of the labs, and all surfaces within the lab. Such tests control the viable bio-burden and thus provide data necessary for establishing the air system’s efficiency in the undertaken operational procedures. For effective Clean room monitoring, environmental monitoring programs aid in establishing a normal range that is then used to monitor deviations and provide remedy interventions.
Molecular Biology Laboratories as Clean Rooms
Molecular biology laboratories work with cells and cellular structures to understand the basis of biological activity. Due to the sensitive nature of work performed in molecular labs, these areas are clean rooms and thus clean room monitoring is essential to ensure the integrity of all work performed in the labs. Molecular labs offer services including;
- Gene editing and synthesis services
- DNA purification services
- PCR/qPCR analysis
- Sequencing services