Application Notes Archive

Microbial Contamination Monitoring and cleanroom data management

Contamination Control Strategies for Innovation and Regulatory Compliance FAQ

Particle Measuring Systems (PMS) recently hosted a webinar titled Contamination Control Strategies for Innovation and Regulatory Compliance to explain how the implementation of a CCS attempts to address the varied causes of contamination and compromised sterility. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by Ugo Omeronye .

Airborne Nanoparticle Detection in Semiconductor Tools

The increasing attention on driving better product yield performance with advanced technology nodes has drawn reasonable discussion for in-tool monitoring to reduce nanoparticles that can have an impact on yield. With that in mind, Particle Measuring Systems (PMS) launched the new NanoAir™ 10 Condensation Particle Counter that measures particles down to 10 nm and the ParticleSeeker™ Smart Manifold system which is the first-ever manifold designed to handle nanoparticle transport. This product will unlock a new world of monitoring possibilities, providing a look into a current blind spot of the requirements and needs in the industry.

Isokinetic Particle Sampling in Unidirectional Flow

A cleanroom with unidirectional airflow utilizes a controlled, steady velocity of air in parallel streamlines that move in one direction to minimize the potential movement of contamination. Unidirectional cleanrooms are typically designed using laminar airflow hoods that direct the air, and the airflow is designed to wash particles from a potential contamination source away from the process risk before being exhausted from the process area.

Particle Contamination in High-Purity Process Chemicals

ISO/14644 -21:2023 Technical Report 21 / TR 21

The Technical Committee (ISO/TC209) responsible for ISO 14644, the set of Standards governing cleanrooms and associated controlled environments, looked at the need for a new document to aid users in the application of airborne particle counters; especially considering the new revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) describes the application of particle counters for classification and monitoring to provide sufficient proof that the cleanroom performance both meets the required standard and is demonstrated to be maintained within ‘normal’ operating conditions.