Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series will go into depth on both topics.
최신 부록1의 초안은 세척, 오염 제거 그리고 소독에 대한 몇가지 업데이트를 포함하고 있습니다. 정의 제품 및 소독제 잔류물과 같은 오염 제거를 위한 새로운 세척 프로세스 오염 제거 란 지역, 물체 또는 사람으로부터의 오염 물질 (화학 물질, 폐기물, 잔류 물 또는 미생물)을 제거하거나 줄이는 전체 과정을 말한다. 오염 제거 방법 (예: 세척, 소독, 멸균)은 오염 […]
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
PMS는 지속적이고 신뢰할 수 있는 사후 서비스의 중요성을 잘 알고 있습니다.
Kim Jong-choul, country manager of American semiconductor systems provider, Particle Measuring System, says all his life as an engineer and CEO of a research center has been about problem-solving.
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.
전통적인 세계적인 세미콘 흐름에 맞춰, PMS는 1월 세미콘 코리아에서 주목할 만한 부스 프레젠테이션을 선보였습니다. 부스의 전체 테마는 “1972년부터 시작된 오염물질 모니터링의 세계적인 전문가” 였습니다. PMS는 광범위한 범위의 반도체 회사들로부터 나온 220여 명의 방문객을 만났습니다. 대부분의 방문객들은 한국인들이었지만 중국, 대만, 일본, 말레이시아, 미국, 그리고 유럽 방문객도 상당 수 있었습니다.
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.