In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. We’ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.
Global company expands environmental commitment with multiple programs at Boulder Headquarters.
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.