A comprehensive cleanroom environmental monitoring strategy combines real-time data acquisition, analysis, and reporting to support validation and ongoing compliance efforts, all while protecting your valuable scientific work.
Keeping Your Cleanrooms Clean: Effective Monitoring Practices and Parameters
As every lab professional knows, keeping a cleanroom clean takes far more than a broom and a spray bottle of Lysol.
In each industry, cleanrooms are designed and built to the unique specifications of that industry: the cleanroom for a biotech focused on genetic testing will have very different parameters than that of, say, a pharmaceutical or semiconductor company.
The good news is that, for most industries, the standards — such as the International Standards Organization (ISO) — are established and need only be adhered to. The challenge is staying on top of adherence:
How do you consistently, completely, and constantly ensure your cleanrooms are in compliance?
How do you adapt to changing standards on-the-fly?
How do you move your business forward when, in so many cases, you have to keep looking over your shoulder to ensure compliance?
The answer is most often automation. By using automated monitoring systems and services, you need not worry about the “cleanliness” of your cleanrooms. Combinations of hardware and software exist that have standards built-in, reporting mechanisms in place, and a full suite of compliance features.
Before digging into tools and tactics to further monitoring automation, let’s explore some specific classifications, and parameters for validation.
Validation helps ensure cleanrooms meet specific standards classified according to ISO. Such standards help regulate degrees of cleanliness, and are defined by factors such as particle count and size, and air changes rates, among others (outlined in ISO 14644-1). These classifications also help ensure the integrity of products (pharmaceuticals, semiconductors, etc.) that may be contained in a cleanroom.
The validation process naturally requires inspection and testing, but also means labs must perform ongoing monitoring to demonstrate continued compliance (as these standards are never “one and done”; it’s more like “all day, every day”).
Having a comprehensive cleanroom environmental monitoring strategy that combines data acquisition, analysis and reporting is evermore critical as it can support validation, ongoing compliance efforts, and protect valuable scientific work.
Cleanroom Validation Parameters
For the purposes of the modern laboratory, cleanroom ISO Classes (1-9) are based on air cleanliness by particle concentration, with specific maximum allowable concentrations (particles/m3) for particles from 0.1 to 5 µm. Particle counts must be performed in accordance with ISO 14644-1, and must be repeated periodically to demonstrate ongoing compliance.
If you’ve ever worked in a lab, though, you likely know that “periodically” isn’t a remotely scientific milestone. A lot can happen during the time gaps built-in to “periodically.” For a multitude of reasons, air cleanliness can shift moments after a count, and specimens can go bad, tests can fail, etc. Which is why, when it comes to testing for particle counts, most labs lean on 24/7 monitoring, rather than periodic “check ins.”
And particle counts are really only the start: there are myriad tests and parameters outlined in ISO standards that could impact daily compliance in your cleanroom(s). E.g., tests for ultrafine airborne particles, macroparticles, airflow, air pressure difference, temperature, humidity, and more may be appropriate.
The good news is that most every parameter can be incorporated into a monitoring program that can help automatically ensure a more consistent cleanroom environment.
The Case for Proactive Cleanroom Environmental Monitoring
Let’s stick with the airborne particle count and related ISO standards. (And something to consider for most labs: is ISO alone enough?)
Despite detailed test procedures that specify the number of sample points, sampling locations, apparatuses, and data required for reporting according to ISO 14644-1, you’re still only getting a snapshot of the cleanroom environment. Without continuous data for particle count and other critical parameters, it is impossible to identify abnormalities that can impact experiments and products on a daily basis.
Challenges also arise when laboratories rely on multiple, discrete, monitoring devices and platforms to obtain a complete understanding of the cleanroom environment. Not only might these devices be “speaking different languages” (making it difficult to evaluate multiple parameters concurrently) but manually compiling data from different platforms is time-consuming, costly, and prone to error. On top of that, most laboratories simply lack the human resources and expertise required to perform detailed analyses.
The most effective and affordable means of cleanroom environmental monitoring comes down to software, hardware, and a service. And that’s where XiltriX comes in.
The Solution for Proactive Laboratory Cleanroom Monitoring
XiltriX solutions are designed for reliable, comprehensive monitoring of numerous parameters in a single solution.
XiltriX combines data acquisition from numerous sensors, assets, and equipment, with data analysis, reporting and documentation, and provides real-time data for numerous parameters that affect research and product integrity.
In addition to the type of particle counting detailed in this blog, XiltriX monitoring solutions track temperature, relative humidity, differential air pressure, VOCs (volatile organic compounds), various chemicals, light intensity, vibration, and numerous other parameters that provide valuable insight into the cleanroom environment.
In the highly controlled cleanroom environment, fluctuations in any critical parameters can have significant consequences for the experiments and products contained within. XiltriX provides data acquisition, analysis, and reporting on all equipment and environmental parameters, to ensure an optimal cleanroom environment every day. Knowing your cleanroom is clean is as simple as logging in to XiltriX.
Interested in learning more about cleanroom environmental monitoring and how XiltriX can help? Download our white paper "Critical Parameters for Cleanroom Monitoring":