MET ONE 3400+ 系列空氣粒子計數器

我們新型的MET ONE 3400+系列手攜式粒子計數器，採用自動化的SOP控制和採樣圖層點位功能，可加載到計數器中標記採樣位置，並為每個位置定義SOP要求。通過10’’觸碰螢幕輕鬆獲取SOP和採樣點位置圖，採樣後位置圖標呈綠色，使進度一目瞭然，將操作誤差降至最低。

通過web瀏覽器可遠程監控計數器，諸如審核、批准、SOP版本控制和電子記錄導出等功能都可以直接在計數器中獲取，無需額外的軟體。內建安全的搜索/篩選審查追蹤功能可在審核過程中提供快速報告，MET ONE 3400+ 使用微軟活動目錄來控制登錄和電子簽名的用戶名和密碼，支持 21 CFR Part 11 合規性和 ALCOA原則。

*本產品僅供工業與科研使用，不用於臨床診斷

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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.

Quality Control Electronic Records for 21 CFR part 11 Compliance This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.

Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).