Critical Parameters for Cleanroom Monitoring
How 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. 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.
An Overview of 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, leading to more consistent product quality.
Cleanroom Classifications Explained
The chart above outlines the ISO 14644-1 classification scale. Below, we outline the nine ISO cleanroom classifications. We’ve also included their FS 209 E equivalent. While this standard is no longer updated or applicable, many cleanrooms still use the standard to determine how sterile they need their cleanroom environment to be.
ISO 1
ISO 2
ISO 3 (FS 209 E class 1 equivalent)
ISO 4 (FS 209 E class 10 equivalent)
ISO 5 (FS 209 E class 100 equivalent)
ISO 6 (FS 209 E class 1,000 equivalent)
ISO 7 (FS 209 E class 10,000 equivalent)
ISO 8 (FS 209 E class 100,000 equivalent)
ISO 9 (room air)
According to the ISO classification scale, the cleanest cleanroom is considered an ISO 1 classification. To achieve this classification, cleanrooms must provide a known sample that has 10 or fewer particles measuring 0.1 microns and only two or fewer particles measuring 0.2 microns.
As the classification number increases, the ISO scale allows for more and larger particles to be present in samples. According to the chart above, all the way up to ISO 9, which is equivalent to normal room air quality. One change to note from the latest ISO 14644-1 (2015) update is that the ISO 5 classification no longer allows 29 particles of > 5 microns.
How To Certify Your Cleanroom Classification
Step #1: Assess Your Cleanroom Dimensions
First, identify the size of your cleanroom and the specific areas where particle measurement is required. The location and overall dimensions of the entry and exit points will dictate the zones for particle size and count assessment. Particle counters can assist during this step.
Step #2: 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.
Step #3: 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.
Step #4: Calculate Area for Number of Sample Locations
While the latest ISO 14644-1 (2015) update still requires calculation based on the square root of the cleanroom area, it also introduces a table based on the cleanroom size. When you have the area of your cleanroom, the minimum number of sample points needed can be determined from the table below.
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.
Step #5: 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.
Common Pitfalls of Traditional Cleanroom Testing
Airborne particle counts are conducted for classification and test measurement to certify the cleanliness classification of cleanrooms according to ISO 14644-1, or for periodic monitoring as specified in ISO 14644-2. Unfortunately, without the right monitoring system, these periodic particle count tests are not a sufficient cleanroom monitoring solution and can lead to the following pitfalls.
#1: A Lack of Real-Time Reporting
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 daily.
#2: Maintaining Multiple Monitoring Devices and Platforms
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.
#3: A Lack of Human Resources & Expertise Needed
Additionally, many laboratories lack the human resources and expertise needed to perform the detailed analyses necessary to derive valuable insights from environmental monitoring data. Successful cleanroom monitoring and quality control require expertise that many general lab manager teams may lack.#4: Relying on Building Management Systems for Cleanroom Monitoring
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 cleanroom air testing to support informed decisions.
Introducing The Cleanroom Monitoring Solution: 24/7 Live Agent Monitoring from XiltriX
XiltriX solutions are designed for reliable, comprehensive monitoring of numerous cleanroom (and laboratory) parameters in a single platform. 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, but it also provides real-time data for numerous parameters that affect research and product integrity.
In addition to particle counting, XiltriX solutions also monitor temperature, humidity, differential air pressure, VOCs (volatile organic compounds), chemicals, light intensity, vibration, and other key parameters, delivering insights that support the cleanroom environment and air testing.
A red or green LED light provides a quick visual indication that individual parameters are within specified ranges. 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. 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.
