制藥企業(yè)生產(chǎn)環(huán)境在線監(jiān)測(cè)系統(tǒng)簡(jiǎn)介(編輯修改稿)
2025-01-19 03:31 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 d to obtain a meaningful sample. Regular monitoring should be performed during each production shift. We remend conducting nonviable particle monitoring with a remote counting system. These systems are capable of collecting more prehensive data and are generally less invasive than portable particle counters. From Section IV. Buildings and Facilities, Subpart A, Critical Area – Class 100 (ISO 5) “ Nonviable particle monitoring with a remote counting system is generally less invasive than the use of portable counting units and provides the most prehensive data.” 通常使用遠(yuǎn)地安裝計(jì)數(shù)系統(tǒng)監(jiān)測(cè)顆粒通常比使用便攜式顆粒計(jì)數(shù)器少侵入流程 ,且提供最全面的數(shù)據(jù) FDA的工業(yè)指導(dǎo)意見 EU GMP Annex I ? 優(yōu)質(zhì)生產(chǎn)的指導(dǎo) – 無菌產(chǎn)品的生產(chǎn) ? 2023年 9月生效 ? 關(guān)注無菌區(qū)域的顆粒測(cè)試 – 干涉性 – 過濾器的有效性 – 這是個(gè)診斷工具 ? 5微米的采樣 – 5微米可以被看作一個(gè)對(duì)于有機(jī)生命體和規(guī)范的指導(dǎo)性問題 – 理論上，在合適的過程環(huán)境中應(yīng)該不會(huì)出現(xiàn) 5微米的顆粒 – 會(huì)被偶然性的監(jiān)測(cè)到 – 趨勢(shì)需要被調(diào)查 ?修正了 A區(qū)和 B區(qū)的 5微米限制 ?提到了在 A區(qū)和 B區(qū)的連續(xù)監(jiān)測(cè) ?介紹了日常測(cè)試必須采滿 1個(gè)立方米 From EU Annex 1 “The guidance has been reviewed in the light of the international standard EN/ISO 146441 and amended in the interests of harmonisation but taking into account specific concerns unique to the production of sterile medicinal products.”指導(dǎo)意見參考了 ISO14644，規(guī)定了無菌產(chǎn)品的關(guān)注點(diǎn) 2023年 9月 EU附錄 1的改動(dòng) EU GMP附錄 1中對(duì)于連續(xù)監(jiān)測(cè)的描述 “ A continuous measurement system should be used for monitoring the concentration of particles in the grade A zone, and is remended for the surrounding grade B areas.” 在 A區(qū)監(jiān)測(cè)顆粒濃度應(yīng)當(dāng)使用一個(gè)連續(xù)測(cè)量的系統(tǒng) ,而且建議包圍 A區(qū)的 B區(qū)也是這樣做 . EUGMP 2023年的修改 Limits at 5 microns for Class A and B A區(qū) B區(qū)的 5微米限制 0 per cubic meter ? 1 per cubic meter允許 1個(gè) /立方米 G r a d e M a x i m u m p e r m i t t e d n u m b e r o f p a r t i c l e s / m3 e q u a l t o o r a b o v e0 . 5 181。 m 5 181。 m 0 . 5 181。 m 5 181。 mA 3 5 0 0 1 3 5 0 0 1B 3 5 0 0 1 3 5 0 0 0 0 2 0 0 0C 3 5 0 0 0 0 2 0 0 0 3 5 0 0 0 0 0 2 0 0 0 0D 3 5 0 0 0 0 0 0 2 0 0 0 0 n o t d e f i n e d n o t d e f i n e dA t R e s t I n O p e r a t i o nEU附錄 1摘要 Note: Revision of EU Annex 1 is in process。 final draft not until late 20
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