부유 미립자 계수기 - 환경 모니터링, 클린룸 밸리데이션
무균 의약품 관리 시설, 의약품/식음료 제조 시설 및 병원 실험실 등에서는 환경 모니터링을 통해 공기 중 부유 입자 농도를 제어하는 클린룸 밸리데이션이 필수입니다. 이는 클린룸 상태에서의 청정도가 이루어졌음을 입증할 수 있습니다.
벡크만쿨터는 환경 모니터링 및 클린룸 밸리데이션을 진행하기 위한 다양한 부유 미립자 계수기를 제공합니다. MET ONE 부유 미립자 계수기는 ISO 14644, FDA cGMP 및 EU GMP Annex 1에 따라 공기 청정도를 모니터링할 수 있는 솔루션을 제공하는 업계의 대표적인 제품입니다. 이동형, 원격 및 휴대형 부유 미립자 계수기는 무균 작업 중 환경 모니터링, 비작업 중 환경모니터링, 클린룸 및 Flow Bench 밸리데이션, 일탈에 따른 추적/조치등을 위해 청결 상태를 모니터링할 수 있도록 표준 작업 절차(SOP)에 통합이 용이하게 설계되었습니다. ISO 21501-4를 준수하는 MET ONE 부유 미립자 계수기는 신뢰할 수 있고 내구성이 뛰어나며 21 CFR Part 11 규정을 준수하는 워크플로우에 쉽게 통합됩니다.
필요한 부유 입자 측정 기준 및 청정도 검사에 적합한 벡크만쿨터의 부유 미립자 계수기 제품을 살펴보세요.
FAQ on Air Particle Counters
What is the difference between portable, handheld, and remote particle counters?
Portable particle counters are designed for routine monitoring and cleanroom certification activities. Handheld particle counters provide convenient spot-checking and troubleshooting in small or difficult-to-access areas. Remote particle counters are permanently installed for continuous monitoring and integration with facility monitoring systems.
What standards are commonly associated with air particle counting?
Air particle counting is often associated with ISO 21501-4, which outlines performance and calibration requirements, and the ISO 14644 series, which defines cleanroom classification standards, monitoring and testing. Other standards related to airborne particle monitoring include EU GMP Annex 1 and FDA cGMP for pharmaceutical environments, as well as standards that are related to particle counting electronic data records like 21 CFR Part 11.
Why are air particle counters important for cleanroom monitoring?
Air particle counters provide organizations with important information used to assess cleanroom performance and monitor airborne particle contamination levels. Particle contamination can affect product quality and safety as well as process consistency within cleanrooms and other controlled environments. Particle count data also supports cleanroom classification, environmental monitoring programs, contamination investigations and compliance activities associated with ISO 14644, FDA cGMP requirements and EU GMP Annex 1 guidance.
What is an air particle counter?
An air particle counter measures and counts airborne particles within a defined volume of air. These systems are commonly used in cleanrooms, pharmaceutical manufacturing facilities, medical device production environments, and laboratories to monitor contamination levels and verify air cleanliness.
What particles can an airborne particle counter detect?
Airborne particle counters detect and count particles suspended in the air, within the size range supported by the counter. Depending on the model and configuration, MET ONE airborne particle counters can measure particles from 0.3 to 10.0 µm. Individual counters report particles at defined size thresholds, such as 0.3, 0.5, 1.0, 2.0, 3.0, 5.0 or 10.0 µm. Available size channels vary by model. For example, some counters are configured to monitor the 0.5 µm and 5.0 µm particle sizes commonly used in pharmaceutical cleanroom monitoring.
How does continuous particle monitoring support GMP compliance?
Continuous particle monitoring provides real-time cleanroom data throughout manufacturing operations. Organizations use this data to identify excursions, investigate contamination events, document environmental conditions and support contamination control strategies. Continuous monitoring systems may also simplify long-term data retention, trend analysis and review activities when used within an organization's quality management framework. Automated air particle monitoring systems can also support audit trails and electronic record requirements.
