新聞部落格

As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).

Through continuous process and equipment advancements, semiconductor manufacturers are approaching 14 nm feature sizes and heading even smaller, while hard-disk drive fly heights are now less than 10 nm. This ever-reducing device feature size requires comparable cleanliness-level improvements in ultrapure water (UPW). UPW purity is especially important with its high use in direct contact with wafers as a final cleaning and rinsing agent in many production steps. Leveraging recent advances in laser optics and detector technology, UPW particle concentration ≥20 nm (≥9 nm for metallic particles) can be effectively monitored.

Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?

The recent revision of ISO 14644-1 and-2 has introduced several changes for cleanroom classification and monitoring guidelines. This paper highlights the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

Gilberto Dalmaso, Global Aseptic Process Development Manager at Particle Measuring Systems, has contributed to a newly released book with Rapid Microbial Methods (RMM), published by The Pharmaceutical and Healthcare Sciences Society. The book, titled PHSS Technical Mongraph No. 20 Bio-contamination, is a comprehensive review and best practice guide on bio-contamination characterization, risk profiling, control, monitoring and deviation management. It applies to controlled environments in GMP and non sterile applications where Bioburden control is required.