Critical Parameters for Cleanroom Monitoring
Real-Time Cleanroom Monitoring Supports Validation and Compliance
Validation is crucial to ensure cleanrooms meet the specific standards set by the International Standards Organization (ISO). These ISO classifications, which regulate cleanroom cleanliness, are determined by factors like particle count and size, air change rates, and other parameters outlined in ISO 14644-1. Such classifications guarantee the integrity of products ranging from pharmaceuticals to semiconductors housed in cleanrooms. The validation process involves inspection and cleanroom air testing, and laboratory organizations must conduct ongoing monitoring to maintain compliance with these standards. A comprehensive cleanroom monitoring strategy, incorporating data acquisition, analysis, and reporting, supports both validation and continuous compliance efforts while protecting valuable scientific work.
ISO Cleanroom Standards
Cleanroom ISO Classes (1-9) are determined by air cleanliness based on particle concentration, with specific maximum allowable concentrations (particles/m³) for particles ranging from 0.1 to 5 µm. For a cleanroom to achieve ISO 14644-1 classification, particle counting is essential and must be performed periodically to ensure ongoing compliance.
While particle counting is mandatory, ISO standards also outline various optional tests and parameters. Depending on the specific applications within the cleanroom, additional tests for ultrafine airborne particles, macroparticles, airflow, air pressure difference, temperature, and humidity may be appropriate and should be integrated into a monitoring program. In fact, monitoring multiple parameters alongside particle counting can help maintain a more consistent cleanroom environment.
How To Certify Your Cleanroom Classification
Assess Your Cleanroom Dimensions
First, identify the size of your cleanroom and the specific areas where particle measurement is required. The entry and exit points' location and overall dimensions will dictate the zones for particle size and count assessment. Particle counters can assist during this step.
Establish the Required Cleanliness Level
Next, determine the cleanliness level for your classification. This will guide you in identifying the target particle size and concentration. Ensure your particle counter can accurately measure particles within the specified size and concentration ranges.
Conduct Area Measurements
During your annual or semi-annual cleanroom classification verification, perform four key tests to gather essential data for classification and maintenance:
Airflow Volume/Velocity Readings: Verify that the airflow quantity and direction are within specified limits.
HEPA Filter Testing: It ensures that there are no leaks in the HEPA filter. Though not mandated by ISO standards, this test is often required by regulatory bodies such as the FDA.
Non-Viable Particle Counting: This test will establish the cleanroom classification. This test measures the number and size of particles in a specific area.
Room Pressurization Testing: This confirms that the room maintains the correct pressure levels.
Calculate Averages
Compute the average particle size and count for each measurement location. Subsequently, derive an overall average by calculating the mean of these location-specific averages, resulting in a comprehensive particle profile for the cleanroom.
Determine Your Cleanroom Classification
A particle counter can help you determine the Upper Confidence Limit, identifying statistically significant particle sizes and counts. Based on these results, you may identify the ISO classification of your cleanroom.
Where Cleanroom Testing Falls Short
Airborne particle counts for classification and test measurement are conducted to certify the cleanliness classification of cleanrooms per ISO 14644-1, or for periodic monitoring according to ISO 14644-2. Although detailed test procedures specify the number of sample points, sampling locations, apparatuses, and data required for reporting, performing these tests at the minimum required frequency provides only a snapshot of the cleanroom environment. Without real-time data on particle counts and other critical parameters, it's impossible to detect abnormalities that can affect experiments and products on a daily basis.
Challenges also arise when laboratories rely on multiple monitoring devices and platforms to fully understand the cleanroom environment. Manually compiling data from individual platforms is extremely time-consuming, and makes it difficult to evaluate multiple parameters together to identify the root cause of abnormalities. For instance, correlating particle counts with occupancy states or other ambient parameters may yield more relevant, actionable data than a single elevated particle count. Additionally, many busy laboratories lack the human resources and expertise needed to perform the detailed analyses necessary to derive valuable insights from environmental monitoring data.
Relying on the building management system for cleanroom monitoring is not enough. These systems are designed to monitor and control power, lighting, and ventilation but are not equipped to acquire scientific data, create trend reports, or provide clean room air testing to support informed decisions.
A Comprehensive, Continuous Cleanroom Monitoring Solution
XiltriX solutions are designed for reliable, comprehensive monitoring of numerous cleanroom (and laboratory) parameters in a single software. XiltriX combines data acquisition from numerous sensors, assets, and equipment, with data analysis, reporting, and documentation. This powerful solution not only facilitates validation and supports ongoing compliance, it also provides real-time data for numerous parameters that affect research and product integrity.
In addition to particle counting, XiltriX monitoring solutions monitor temperature, 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 and aid cleanroom air testing. A red or green LED light provides a quick visual indication that individual parameters are within specified ranges. The system can also integrate information with badge reader access, to determine which staff were present while measurements were being taken. The system is designed with flexibility in mind, and XiltriX experts can assist in creating a perfectly tailored solution, with numerous options for expansion as required.
A comprehensive monitoring solution goes beyond alerts and notifications, and leverages monitoring data to provide predictive analytics and automated quality reports. The XiltriX SafetyNet team actively monitors deviations and alerts customers of potential problems before equipment failure occurs. The team also creates custom reports to meet specific quality and compliance requirements, and can assist in generating the necessary information in the event of an audit.
In the highly controlled cleanroom environment, fluctuations in critical parameters can have significant consequences for the experiments and samples contained within. XiltriX solutions provide data acquisition, analysis, and reporting on all equipment and environmental parameters to ensure an optimal cleanroom environment 24/7.
To learn more about how XiltriX can ensure your lab’s critical assets and equipment are protected, book a demo with one of our experts.