【正文】 Electronics Serial Data Out Sensor Sample inlet Flow Monitor Pump Filter Sample exhaust ? Sensor傳感器 Counter計數(shù)器 Pump泵 Output輸出 光散射計數(shù)儀典型構成 光散射計數(shù)儀工作原理 Laser 激光 Detector 光感器 Mirror Particle 顆粒 Light Trap 光阻器 Detector Output – No Particle Mirror 反光鏡 Detector Output with Particle ? 高能量的激光二極管 ? 穩(wěn)定的光學系統(tǒng) ? 經(jīng)過了耐久性測試 ? 確認了激光的使用壽命 ? 經(jīng)過加速老化試驗表明，儀器至少可以使用 10年以上 Accelerated Tests at 75 Degrees Celsius and Full Power 顆粒大小 顆粒越大，輸出脈沖就越大 目錄 ?公司簡介 ?顆粒的定義及危害 ?激光粒子計數(shù)器 ?潔凈室顆粒檢測法規(guī) ?日常檢測方式 ?連續(xù)監(jiān)測系統(tǒng)布點及配件 ?系統(tǒng)監(jiān)控軟件 LMS Pharma Edition ?公司業(yè)績 潔凈室空氣顆粒監(jiān)測的標準 ?制藥廠的藥品無菌化生產(chǎn) – FDA Guidance for Industry ? Sterile Drug Products Produced by Aseptic Processing 無菌藥品生產(chǎn)的無菌處理 – EU GMP Annex I ? Manufacture of Sterile Medicinal Products 無菌藥品的生產(chǎn) – 中國 2023GMP征求意見稿 ?首次公布時間 1987年 6月 ?新版本公布： 2023年 9月 ?公布的數(shù)據(jù)要求公制化 – 立方英尺 〉立方米 – 1個立方米 = ?涉及 ISO 146441 – FED209E百級 ?ISO 5級 – 針對 3520個 /立方米 FDA工業(yè)指導意見 ?主要關注潛在的產(chǎn)品暴露區(qū)，定義 2個區(qū)域 – Critical (similar to Grade A) 關鍵區(qū) – Controlled (similar to Grade C or D support areas)受控區(qū) ?監(jiān)控 ?采樣點位置 – “Not more than 1 foot away from the work site, within the airflow, and during filling/closing operations” 在氣流中和罐裝區(qū)離工作區(qū)域不能大于 1英尺 FDA的工業(yè)指導意見 Contains Nonbinding Remendations Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when it has a percubicmeter particle count of no more than 3520 in a size range of μm and larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations. This level of air cleanliness is also known as Class 100 (ISO 5). We remend that measurements to confirm air cleanliness in critical areas be taken at sites where there is most potential risk to the exposed sterilized product, containers, and closures. The particle counting probe should be placed in an orie