Environmental monitoring, especially particle counting, in cleanrooms is used to show that said cleanroom operates within its set parameters before and during manufacturing processes. The safety and quality of products can be affected if too many particles enter the manufacturing space or process. However, this monitoring is commonly still a manual process in many cleanrooms instead of routine or continuous particle counting. Cleanrooms are highly regulated environments that require the utmost attention to air quality and cleanliness.
Difference Between Cleanroom Classification and Monitoring
Cleanroom classification and monitoring are related, but they are not the same. Classification is determined by ISO 14644 and focuses on if the air quality of the room performs better than the target class limits. Classification is essential for continued compliance to applicable cleanroom standards. On the other hand, monitoring is focused more on risk assessment. With cleanroom monitoring, areas within the space where product is at risk of contamination are observed to ensure the air quality is within the limits specified by the cleanroom classification.
What can continuous particle counter tell you?
While many facilities measure particle counts on a schedule (quarterly or bi-annually), continuous non-viable particle counting is not yet common practice in the majority of cleanrooms. Non-viable particles often act as vehicles for airborne bacteria, viruses, and other contaminants while also aiding in their propagation.
Continuous particle counting, with properly set alarms, can indicate potential issues within an otherwise sterile processing environment. A measurable spike in particle counts can lead to the discovery issues such as a gap in a door seal or a malfunctioning piece of air handling equipment. Additionally, the continuous logging of particle counting data can help exonerate a compliant cleanroom in the case of an incident investigation, ensuring yet another level of confidence about the air quality in your facility.
How Setra Can Help
The goal of cleanroom monitoring is to assess the potential contamination risk of the product. Setra’s SPC5000 or SPC7000 series particle counters are well suited to provide real-time monitoring of particulate counts in a cleanroom. Ideal for monitoring potential contamination in cleanrooms and ensuring adherence to ISO standards, Setra’s particle counters seamlessly integrate to monitoring software for data retention and reporting.
Setra’s Continuous Environmental Monitoring Solution (CEMS) and accompanying software continuously monitors environments to minimize the risk of contamination, provide data visibility and production oversight, simplify operations, and improve the quality of products. CEMS software provides alarming, real-time trend data, and reports for compliance with the FDA (ISO & 21 CFR Part 11) and GxP regulations.