Lighthouse: Data Integrity in Environmental Monitoring

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 the 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.

Monitor self-diagnostics

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 with your cleanroom. Sensor health can be monitored constantly and anything that compromises integrity will trigger an alarm. Make sure the alarm is easy to recognize by users in and outside of the working environment.

Figure 1 Factory acceptance testing setup of a monitoring system

Connectivity

Keeping your monitors connected ensures not only the fastest way to catch alarms, but systems such as CIFS file sharing provide a secure network to collect data. Furthermore, API connectivity allows monitor data to connect to third-party software, such as a LIMS system.

Validation

Validation of data is needed for compliance to trace the records to their location and the quality of their accuracy. Look for a counter that has built-in protocols for performance quality before building out your cleanroom.

Figure 2 Validation of remote particle sensor in cleanroom

User permissions

Another key element of data integrity is the level of security the device has for individual users. For the highest quality data integrity, your tools need to meet guidelines that enforce different levels of permissions, from operator to manager or administrator, as well as password protocols.

Apex Z monitors check all the conformity boxes

All of the above features are just the beginning when considering the data integrity of your environmental monitoring system. Apex Z monitors check all these boxes for conformity and more. Furthermore, Lighthouse Worldwide Solutions prides itself on being an industry leader in compliance. Contact them to learn from their vast knowledge base and trust them to guide you through every step of cleanroom set-up and monitoring, ensuring the best quality for your manufacturing needs.

 

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