pdatr13環(huán)境監(jiān)控-資料下載頁(yè)
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【正文】 o select a site at the most critical location. Oneshould consider whether critical site monitoring would actually increaseprobability of product contami nation. Additionally, critical sites may not bemonitored if there is a low probability of contamination during processing(., sterilized ponents which are not manipulated). 然而，必須承認(rèn)在最關(guān)鍵的位置選擇取樣點(diǎn)并不實(shí)際。應(yīng)該考慮到關(guān)鍵位置監(jiān)測(cè)是否實(shí)際上增加了產(chǎn)品污染的可能性。此外，如果加工過(guò)程中污染的可能性低，則不能監(jiān)測(cè)關(guān)鍵取樣點(diǎn)（如未操控已消毒組件）。As pointed out in other sections of thisdocument, there are many considerations in establishing an appropriate site forsampling (., facility design, line configura tions, validation data,process, historical data, test meth odology, etc.). The sites listed in thissection may or may not be applicable to a particular manufacturing process。factors pertaining to site selection are likely to be unique to ，建立相關(guān)取樣位置需考慮到很多方面（例如，設(shè)施設(shè)計(jì)，線路配置，驗(yàn)證數(shù)據(jù)，工藝，歷史數(shù)據(jù)，測(cè)試方法等）。本節(jié)中列出的取樣點(diǎn)不一定適用于一個(gè)特定的生產(chǎn)工藝，位置選擇的相關(guān)因素對(duì)每個(gè)設(shè)施可能都是獨(dú)一無(wú)二的。 Sampling Frequency取樣頻率Monitoring requirements may vary widely inthe indus try depending on several factors including, but not lim ited to, typeof manufacturing process or product, fa cility/process design, amount of humanintervention, use of subsequent terminal sterilization (including ste rilitytest release versus parametric release), and his torical profiles of themicrobiological environmental data. No single sampling scheme is appropriatefor all environments. In addition, changes in sampling fre quency, whethertemporary or permanent, may be re quired based on changes in practices,pendial require ments, development of significant microbiological trends,acquisition of new equipment, or nearby construction of rooms or utilities. Thekey is to select monitoring frequen cies that can identify potential systemdeficiencies. 監(jiān)測(cè)要求根據(jù)若干因素可能會(huì)有很大區(qū)別，包括但不限于，制造工藝或產(chǎn)品類型，設(shè)施/工藝設(shè)計(jì)，人員干擾數(shù)量，隨后最終滅菌的使用（包括無(wú)菌測(cè)試放行與參數(shù)發(fā)布的對(duì)比），微生物環(huán)境數(shù)據(jù)的歷史概況。沒(méi)有任何單一的取樣計(jì)劃適用于所有環(huán)境。此外，根據(jù)規(guī)范，藥典要求，重要微生物的趨勢(shì)發(fā)展，新設(shè)備的購(gòu)置或附近房間或公用事業(yè)建設(shè)，可能要求取樣頻率的變化，不論是暫時(shí)的或永久的。關(guān)鍵是要選擇可以發(fā)現(xiàn)潛在系統(tǒng)缺陷的監(jiān)測(cè)頻率。Examples of sampling sites. 取樣點(diǎn)舉例System系統(tǒng)Site位置? Environmental air (filling line) 環(huán)境空氣（灌裝線）? Near open and/or filled containers靠近打開(kāi)和/灌裝的容器? Room air房間空氣? Proximal to work area接近工作區(qū)? Water水? Point of use使用點(diǎn)? Surface (facility)表面（設(shè)施）? Floor, door handles, walls, curtains地面，門(mén)把手，墻，窗簾? Surface (equipment)表面（設(shè)備）? Filling line, control panels, stopper bowl灌裝線，控制面板，瓶塞料斗? Compressed air壓縮空氣? Site farthest from pressor離壓縮機(jī)最遠(yuǎn)的位置? Sterility test manifold曲菌測(cè)試支管? Port closest to vacuum source最接近真空源的口? Operator on filling line灌裝線操作員? Finger impressions, at a minimum至少是手指印痕? Laminar air flow (., hood)空氣層流（如層流罩）? Near high activity areas靠近高活動(dòng)區(qū)The test frequency per site may be lessfrequent than the system or area frequency (., one may choose to rotatesample sites). Test frequencies for batchrelated, inprocess monitoring maydiffer from those for rou tine area monitoring. In many cases, monitoring per formedin conjunction with batch production may ful fill the requirements for routinearea monitoring. 每個(gè)位置的測(cè)試頻率可能低于系統(tǒng)或區(qū)域頻率的頻繁（例如，可以選擇輪換取樣點(diǎn)）。批相關(guān)的處理中監(jiān)測(cè)的測(cè)試頻率可能不同于常規(guī)區(qū)域監(jiān)測(cè)。在許多情況下，與批生產(chǎn)相關(guān)的監(jiān)測(cè)可能滿足日常區(qū)域監(jiān)測(cè)的要求。Prior to implementing any reduction infrequency, a summary of historical data, along with current and pro posedsampling frequencies, should be reviewed and approved by the appropriateQuality Assurance person nel. After reduction, data should be reviewed periodi callyto determine if the reduced sampling frequency is still appropriate. 減少任何頻率前，歷史數(shù)據(jù)總結(jié)以及現(xiàn)有和擬議取樣頻率，應(yīng)由相關(guān)質(zhì)量保證人員進(jìn)行審查并批準(zhǔn)。減少后，數(shù)據(jù)應(yīng)定期審查，以決定減少后的取樣頻率是否仍適合。歡迎您的光臨，！希望您提出您寶貴的意見(jiàn)，你的意見(jiàn)是我進(jìn)步的動(dòng)力。贈(zèng)語(yǔ)； 如果我們做與不做都會(huì)有人笑，如果做不好與做得好還會(huì)有人笑，那么我們索性就做得更好，來(lái)給人笑吧！ 現(xiàn)在你不玩命的學(xué)，以后命玩你。我不知道年少輕狂，我只知道勝者為王。不要做金錢(qián)、權(quán)利的奴隸；應(yīng)學(xué)會(huì)做“金錢(qián)、權(quán)利”的主人。什么時(shí)候離光明最近？那就是你覺(jué)得黑暗太黑的時(shí)候。最值得欣賞的風(fēng)景，是自己奮斗的足跡。壓力不是有人比你努力，而是那些比你牛幾倍的人依然比你努力。學(xué)習(xí)
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