【正文】 mental monitoring programs should befamiliar with a variety of regulatory schemes if they are to be successful inserving the United States and International product markets. Efforts atharmonization are underway, and it is possible that many of the differences inthe requirements for monitoring programs may disappear as the countries andorganizations involved e to some agreement on the overall approach to betaken. Therefore, it is importantto keep up to date onthe requirements for the different countries in which the product will be sold. 環(huán)境監(jiān)測程序應(yīng)根據(jù)合理的科學(xué)原則，收集到的數(shù)據(jù)的需求和使用進(jìn)行設(shè)計和執(zhí)行，符合政府機(jī)構(gòu)監(jiān)管生產(chǎn)現(xiàn)場的要求。This will ensure that the established program meets the monitoringrequirements of each country. If the intent is toserve both the United States and the International markets, the most stringentrequirements should be evaluated as the basis of an environmental monitoringprogram. 這將確保既定的程序符合每個國家的監(jiān)測要求。Federal Standard 209E establishes airborneparticulate cleanliness classes categorized as Class M 1 through M 7 (SInames). All of the classifications can be applied to particles , while other particlesizes, ., , , and 5μm, utilize only some ofthe classifications. In the United States, the pharmaceutical industryclassifies production areas as Class 100, 10,000 and 100,000 (M , M andM , respectively) based on particles , the classificationreflecting the number of particles per cubic foot. It should be noted that theInstitute for Environmental Sciences and Technology (IEST) has remended thatFederal Standard 209E be retired by the end of 2001 as a result of the publicationof the ISO 146441 and 146442 documents. 美國聯(lián)邦標(biāo)準(zhǔn)209E規(guī)定空氣中微粒潔凈度M1到M7級。FDA39。USP general information chapter 1116 Microbial Evaluationand Classification of Clean Rooms and Other Controlled Environmentsproposes limits for clean room levels, including air, surfaces, and personnelworking within the clean area. The chapter includes threeclassifications that would supplement the current categories based onnonviable particulate limits. 美國藥典的一般信息章節(jié)“1116”“微生物評估和潔凈室分級及其他受控環(huán)境”提出了潔凈室級別的限制，包括潔凈區(qū)空氣，表面和人員工作。與每個等級相關(guān)的是每立方米微粒最大允許數(shù)量。這些文件的副本可從美國國家標(biāo)準(zhǔn)學(xué)會（ANSI）獲得。CGMP規(guī)定，監(jiān)督環(huán)境監(jiān)測計劃的人員應(yīng)有科學(xué)學(xué)科的能力，并有相關(guān)培訓(xùn)和權(quán)威。清洗，殺菌/消毒，選址，以及測試頻率是良好環(huán)境監(jiān)測計劃的重要組成部分。所有數(shù)據(jù)應(yīng)記錄并分析趨勢。對營養(yǎng)細(xì)胞有效的消毒劑可能對孢子無效。該程序還保證了產(chǎn)品和洗滌劑殘留去除的效率。這規(guī)定了消毒劑的實際效力。取樣的主要目的應(yīng)是提供有意義可解釋的數(shù)據(jù)，可以幫助確定與具體程序，設(shè)備，材料和工藝相關(guān)的實際或潛在污染問題。To establish routine sample sites, action andalert levels, and testing frequency, one should take into consideration theextent of contact or exposure that each element of the manufacturingenvironment has with the product. Sites having greater opportunity for contributingbioburden to the product should be sampled and monitored. Product contactsources may include pressed gases, room air, manufacturing equipment,tools, critical surfaces, storage containers, conveyors, gloved hands ofpersonnel, and water. Examples of nonproduct contact sources may includewalls, floors, ceilings, doors, benches, chairs, test instruments, andpassthroughs. 為建立常規(guī)取樣點(diǎn)，報警和行動等級，測試頻率，應(yīng)該考慮到每個生產(chǎn)環(huán)境要素與產(chǎn)品的聯(lián)系或接觸程度。It must be recognized, however, that it maynot always be practical to select a site at the most critical location. Oneshould consider whether critical site monitoring would actually increaseprobability of product contamination. 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)并不實際。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，線路配置，驗證數(shù)據(jù)，工藝，歷史數(shù)據(jù)，測試方法等）。此外，根據(jù)規(guī)范，藥典要求，重要微生物的趨勢發(fā)展，新設(shè)備的購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，不論是暫時的或永久的。在許多情況下，與批生產(chǎn)相關(guān)的監(jiān)測可能滿足日常區(qū)域監(jiān)測的要求。贈語； 如果我們做與不做都會有人笑，如果做不好與做得好還會有人笑，那么我們索性就做得更好，來給人笑吧！ 現(xiàn)在你不玩命的學(xué)，以后命玩你。最值得欣賞的風(fēng)景，是自己奮斗的足