Airborne particles in a controlled environment can have a significant negative impact on the integrity of the work performed and could even pose health risks. Airborne particle counting (AKA nonviable particle counting) is performed by pulling a predetermined volume of air into a device such as a discrete laser particle counter where any measured particles are both counted and sized. This testing is commonly referred to as “Non-Viable Particle Counting” but the reality is that the particle counter only counts and sizes each particle, it doesn’t determine if the particle is living or not.
Cleanroom Testing for Nonviable Particles
Cleanroom classification based on airborne particle concentration is a critical step toward protecting your product from unwanted contamination. Since it is very difficult to have a cleanroom totally void of any airborne particles, ISO 14644-1 defines multiple different room classifications based on the allowable number of designated particles in each cubic meter of air. The appropriate cleanliness level (ISO Class) is dictated by the specific product and the manufacturing process. Verification that the required cleanliness level is always maintained, helps to prevent loss time and revenue.
Why Is Particle Counting Important?
Airborne particle counting is important for numerous reasons: worker safety, product quality and integrity, testing and research integrity, end user safety, certification, compliance and more. Since airborne particles are so easily introduced into the cleanroom environment and because gowning and other cleanroom procedures can be particle generators themselves, it is critical to perform frequent airborne particle testing to ensure that the cleanroom or controlled environment is operating within spec.
Testing From Technical Safety Services
Technical Safety Services offers a broad range of testing services, including nonviable particle counting to ISO 14644 standards for labs, medical device manufacturers and more. In addition, we provide full testing documentation and can work with you to develop processes to stay in compliance with the latest safety protocols and cleanroom best practices. To learn more about our services, contact us today.