Счетчик аэрозольных частиц серии. MET ONE 3400+ для чистых помещений

Наш новый портативный счетчик аэрозольных частиц серии MET ONE 3400+ позволяет загружать карту и параметры измерений частиц в чистых помещениях прямо в прибор. Таким образом СОП превращается в интерактивную карту на экране счетчика, помогающую пользователям проводить ежедневные измерения. Это снижает требования к обучению персонала и предотвращает ошибки и пропуски при измерениях.

Функции счетчика, такие как утверждение СОП, контроль версий процедуры, экспорт электронных записей, доступны через веб браузер. Не требуется установка дополнительного ПО. Безопасный, сохраняемый на борту счетчика, журнал измерений с функциями поиска и фильтрации записей удобен при аудите. .

Explore MET ONE 3400 Plus Models

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Conducting the ISO 14644-3 Cleanroom Recovery Test with the MET ONE 3400+ This application note reviews the test method and provides guidance on selecting both the “Challenge” and the “Target Cleanliness Limit”. Attention is given to the requirement that the test concentration should not be so high that “residue contamination” becomes a risk.
GMP Cleanrooms Classification and Routine Environmental Monitoring The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.
Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Changes to GMP Force Cleanroom Re-Classifications This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.

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