Validation is an important process to ensure cleanrooms meet specific standards to be classified according to the International Standards Organization (ISO). ISO classifications regulate the degree 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 ensure the integrity of the products, ranging from pharmaceuticals to semiconductors, contained in the cleanroom. The validation process requires inspection and testing, and laboratory organizations must also perform ongoing monitoring to demonstrate continued compliance with standards. A comprehensive cleanroom monitoring strategy that combines data acquisition, analysis, and reporting supports validation and ongoing compliance efforts, and protects valuable scientific work.
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 for a cleanroom to be classified in accordance with ISO 14644-1, and must be repeated periodically to demonstrate ongoing compliance.
While particle counts are a requirement, there are a myriad of other optional tests and parameters outlined in the ISO standards. Depending on the applications carried out within the cleanroom, tests for ultrafine airborne particles, macroparticles, airflow, air pressure difference, temperature, humidity, and more may be appropriate, and can be incorporated into a monitoring program. In fact, monitoring multiple parameters in addition to particle count can help to ensure a more consistent cleanroom environment.
In fact, monitoring multiple parameters in addition to particle count can help to ensure a more consistent cleanroom environment.
The airborne particle count for classification and test measurement is made to certify the cleanliness classification of the cleanroom installation in accordance with ISO 14644-1, or for periodic monitoring according to ISO 14644-2. Despite detailed test procedures that specify the number of sample points, sampling locations, apparatuses, and data required for reporting, performing these tests at the minimum required frequency only provides a snapshot of the cleanroom environment. Without continuous data for particle count and several 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. 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 any abnormalities. For example, correlating particle counts with occupancy states or other ambient parameters may provide more relevant, actionable data than a single elevated particle count. Further, many busy laboratories simply lack the human resources and expertise required to perform the detailed analyses necessary to gain valuable insights from environmental monitoring data.
Relying on the building management system for cleanroom monitoring is also insufficient. These systems are designed to monitor and control power, lighting, and ventilation systems, but are not designed to acquire scientific data, create trend reports, or provide analyses to support informed decisions.
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 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. 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 any of a myriad of critical parameters can have significant consequences for the experiments and products contained within. XiltriX solutions provide data acquisition, analysis, and reporting on all equipment and environmental parameters, to ensure an optimal cleanroom environment every day.