watersystems水系統(tǒng)知識專題講座-資料下載頁
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【正文】 清潔和消毒? Describe cleaning and sanitization activities for each ponent:描述每個組件的清潔和消毒活動– Methods 方法– Chemicals used 使用的化學(xué)物質(zhì)– Frequency 頻次– Duration 持續(xù)時間– Chemical concentration/temperature 化學(xué)濃度 /溫度27 二月 2023 48華潤醫(yī)藥集團(tuán)有限公司Cleaning and sanitization 清潔和消毒? Describe cleaning and sanitization activities required after shutdown 描述系統(tǒng)停機(jī)后需要的清潔和消毒– Define maximum duration of shutdown permitted before sanitization is required 定義系統(tǒng)停機(jī)后最長多久需要消毒– Define other events that require sanitization prior to use of water (. opening loop, contamination etc)定義使用前，哪些情況需要消毒 （例如，敞開的循環(huán)，污染等）– Define duration of monitoring after shutdown or unusual events 定義關(guān)閉或非正常情況下需要監(jiān)控的時間27 二月 2023 49華潤醫(yī)藥集團(tuán)有限公司Validation 驗證? Describe pany policy and practices for validating water systems 描述公司方針和水系統(tǒng)驗證活動– Duration of monitoring 監(jiān)控時間– Sampling locations 取樣位置– Types of testing 監(jiān)測類型– Requirements for revalidation 再驗證要求? SOP will not describes specific system or activities, this will be in Project specific VMP and Protocols. SOP provides guidance to those writing the project specific documents SOP中不會描述具體的系統(tǒng)或活動，而應(yīng)是每個項目的驗證主計劃和方案中的內(nèi)容。 SOP為編寫具體項目驗證文件提供指導(dǎo)27 二月 2023 50華潤醫(yī)藥集團(tuán)有限公司Validation驗證? Initial phase 初始階段– During this phase the operational parameters and the cleaning/ sanitization procedures and frequencies will be developed. Sampling should be daily after each step in the purification process and at each point of use for two to four weeks. The sampling procedure for point of use sampling should reflect how the water is to be. At the end of the two to four week time period the firm should have developed its SOPs for operation of the water ,會制訂操作參數(shù)和清潔 /消毒規(guī)程和頻率。 24周內(nèi)，在純化過程的每一步，以及在每一個使用點(diǎn)，應(yīng)每日取樣。取樣點(diǎn)的取樣規(guī)程應(yīng)反映水的質(zhì)量。 24周結(jié)束時，公司應(yīng)制訂出水系統(tǒng)操作的 SOP。27 二月 202351華潤醫(yī)藥集團(tuán)有限公司Validation驗證? 第二階段 The second phase of the system validation is to demonstrate that the system will consistently produce the desired water quality when operated in conformance with the SOPs. The sampling is performed as in the initial phase and for the same time period. At the end of this phase the data should demonstrate that the system will consistently produce the desired quality of water.系統(tǒng)驗證的第二階段應(yīng)證明，在符合 SOP下運(yùn)行，能持續(xù)產(chǎn)生高品質(zhì)水。取樣的頻次（每日）和時間（ 24周）應(yīng)和初始階段相同。在此階段結(jié)束時，應(yīng)有數(shù)據(jù)顯示系統(tǒng)能持續(xù)產(chǎn)生高品質(zhì)水。52華潤醫(yī)藥集團(tuán)有限公司Validation驗證? 第三階段? The third phase of validation is designed to demonstrate that when the water system is operated in accordance with the SOPs over a long period of time it will consistently produce water of the desired quality. Any variations in the quality of the feed water that could affect the operation and ultimately the water quality will be picked up during this phase of the validation. Sampling is performed according to routine procedures and frequencies. 驗證的第三階段應(yīng)證明當(dāng)系統(tǒng)在符合 SOP下運(yùn)行較長時間，能持續(xù)產(chǎn)生高品質(zhì)水。任何會影響系統(tǒng)運(yùn)行并會影響最終水質(zhì)的進(jìn)水質(zhì)量的變異，都會在此驗證階段進(jìn)行考察。應(yīng)按照日常的規(guī)程和頻次進(jìn)取樣。53華潤醫(yī)藥集團(tuán)有限公司Validation驗證? For Water for Injection systems the samples should be taken daily from a minimum of one point of use, with all points of use tested weekly. The validation of the water system is pleted when the firm has a full years worth of 系統(tǒng)取樣應(yīng)每日至少一個使用點(diǎn)，所有點(diǎn)每周輪檢。當(dāng)公司收集一整年有效數(shù)據(jù)后，水系統(tǒng)驗證完成。54華潤醫(yī)藥集團(tuán)有限公司55Thank You謝謝Questions?問題？華潤醫(yī)藥集團(tuán)有限公司演講完畢，謝謝觀
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