Environmental monitoring lies at the heart of regulatory compliance for cleanrooms used in pharmaceutical, bio-pharmaceutical, and healthcare facilities. Facility managers need to understand what components are needed for a monitoring program, but they must also ensure the data they produce is complete, consistent, and accurate.
Environmental monitoring components
The four components of a larger environmental monitoring program include a non-viable particle air monitor; viable particle monitors for air, surface, and personnel; a monitor for pressure differential; and environmental monitors for temperature and relative humidity. Together, these tools determine air quality for compliance purposes, but they also confirm air cleanliness in areas of high-risk operations.
What is a non-viable particle monitor?
The non-viable particle monitor helps track the contamination of air in a cleanroom. They work with laser diode technology to monitor for particles as small as 0.1 μM. The scattering of the laser light is sensed when particles enter the “view volume” chamber of the monitor. Particle size detection relies upon an accurate flow rate of air pumped
through the monitor. Laser integrity, laser alignment, photodetector health, and sensor contamination are also vital to accurate operation of the instrument.
Particle monitor data integrity
Regulatory compliance or voluntary compliance standards exist to ensure the highest quality and safety of products being manufactured. These standards require that environmental monitoring systems produce data by validated instruments. When considering which particle monitor will work best to meet with your standards, some of these features are vital:
Location of your particle monitor
Cleanrooms used for manufacturing need to be assessed for risk to determine where particle monitors need to be located. This also means that every facility will have multiple non-viable particle monitors. One of the largest risks to data integrity happens when monitors are replaced after servicing them. It is easy to misplace monitors if the location information is not encoded properly. This means that the subsequent data will be tagged for the wrong location. Secure your data integrity by making sure there is a location-tagged docking station that stays in place when the monitor needs to be moved.
To make sure that your environmental monitoring equipment is providing the most accurate information, the monitor should offer extensive self-diagnostics. Data Integrity in Environmental Monitoring Features to look for in your particle monitor to ensure
compliance of your cleanroom. Sensor health can be monitored constantly and anything that compromises integrity will trigger and alarm. Make sure the alarm is easy to recognize by users in and outside of the working environment.