GMP潔凈車(chē)間設(shè)計(jì)要求及總體評(píng)估

    隨著醫(yī)藥、食品工業(yè)的發(fā)展，新的潔凈車(chē)間不斷建設(shè)，原有的生產(chǎn)廠房也必須進(jìn)行改造，使之符合現(xiàn)代潔凈生產(chǎn)的要求。

    1、對(duì)周?chē)�環(huán)境的要求現(xiàn)代化的潔凈車(chē)間不僅要求企業(yè)內(nèi)部廠容廠貌和生產(chǎn)車(chē)間的建設(shè)符合 GMP 的要求，同時(shí)要求工廠周?chē)�的環(huán)境符合特定要求，因此在建廠之前對(duì)建廠地址進(jìn)行環(huán)境評(píng)估很有必要。

    1.1、所建廠房對(duì)環(huán)境要求的評(píng)估即鑒定該地區(qū)是否符合建廠要求。評(píng)估內(nèi)容主要包括三方面：一是該地區(qū)的空氣質(zhì)量；二是水資源 質(zhì)量情況；另外，評(píng)估三通情況即通路、通電、通水情況。

    ①、對(duì)空氣質(zhì)量的評(píng)估了解擬建廠區(qū)周?chē)�大氣環(huán)境質(zhì)量現(xiàn)狀，要求擬建廠房周?chē)�空氣新鮮，通過(guò)空氣過(guò)濾器來(lái)凈化空氣，做到無(wú)污染源，少塵埃。

    ②、對(duì)水資源質(zhì)量的評(píng)估 了解當(dāng)?shù)氐乇硭�、地下水的情況。一般企業(yè)生產(chǎn)使用自來(lái)水，但是有些地方無(wú)自來(lái)水，必需自備井取地下水或取河水，應(yīng)當(dāng)鑒定當(dāng)?shù)厮�質(zhì)情況，以便建廠時(shí)考慮水質(zhì)處理工藝。

    ③、對(duì)廠區(qū)周邊地區(qū)通路、通電、通水情況進(jìn)行評(píng)估。

    1.2、所建廠房對(duì)環(huán)境影響的評(píng)估凈化廠房對(duì)環(huán)境影響的評(píng)估隨著環(huán)境保護(hù)要求的提高越來(lái)越重要，評(píng)估包括三方面：空氣、水資源、噪音。

    ①、對(duì)空氣質(zhì)量影響的評(píng)估 對(duì)排放有毒有害氣體或粉塵的生產(chǎn)廠，要經(jīng)處理達(dá)到當(dāng)?shù)貥?biāo)準(zhǔn)，而且還不能建在城鎮(zhèn)居民區(qū)的上風(fēng)向，宜遠(yuǎn)離居民區(qū)。

    ②、對(duì)水資源影響的評(píng)估 對(duì)水資源有污染的生產(chǎn)廠不能建在居民區(qū)用水資源的上游或周?chē)��?比如水庫(kù)，城鎮(zhèn)居民取水的河流、地下水。并且要了解當(dāng)?shù)匚鬯�排放的情況和流向，經(jīng)過(guò)處理，達(dá)標(biāo)排放。

    ③、噪音嚴(yán)重的生產(chǎn)廠必需遠(yuǎn)離城鎮(zhèn)居民區(qū)。

    2、凈化生產(chǎn)廠建設(shè)的總體規(guī)劃：潔凈車(chē)間建設(shè)的總體規(guī)劃不僅影響到整個(gè)廠區(qū)布局是否合理， 同時(shí)也影響到生產(chǎn)廠以后的發(fā)展，所以規(guī)劃時(shí)不僅要考慮到目前的需要，也要考慮到企業(yè)以后發(fā)展的趨勢(shì)。具體布局首先應(yīng)該了解當(dāng)?shù)爻Ｄ甑娘L(fēng)向狀況，即當(dāng)?shù)仫L(fēng)向頻率圖，然后考慮劃分區(qū)域。

    一般生產(chǎn)廠區(qū)域劃分為生產(chǎn)區(qū)、行政區(qū)、生活區(qū)。生產(chǎn)區(qū)包括凈化生產(chǎn)車(chē)間、庫(kù)房、通用工程。潔凈車(chē)間要考慮所建車(chē)間的性質(zhì)及潔凈級(jí)別的要求。精制、灌裝生產(chǎn)車(chē)間對(duì)環(huán)境空氣潔凈度要求相對(duì)較高，且車(chē)間不排放有毒有害氣體和粉塵，一般布置于常年的上風(fēng)向；萃取生產(chǎn)車(chē)間對(duì)環(huán)境空氣潔凈度要求相對(duì)較低，且車(chē)間間歇排放有害氣體和粉塵，一般布置于高潔凈度車(chē)間的下風(fēng)向；預(yù)處理車(chē)間由于產(chǎn)生粉塵和噪音，一般布置在常年的下風(fēng)向；

    通用工程包括變配電室、鍋爐房等供能設(shè)施，布置于生產(chǎn)車(chē)間的下風(fēng)向。行政區(qū)包括供銷(xiāo)部門(mén)和管理部門(mén)， It is commonly depicted in pornography, but very rarely in mainstream cinema. A female dominant in a master/slave relationship is often termed a Mistress, not to be confused with the colloquial usage of mistress as a kept sexual partner without a similarly formalized power relationship. There were also a very limited number of specialist fetish magazines which featured images of bondage, such as the famous Bizarre magazine published from 1946 to 1959 by the pioneering fetish photographer John Willie, and ENEG Exotique magazine, published 1956-1959. Watersports pornography features sexual activities involving urine, such as golden showers. Pornographic films present sexual fantasies and usually include erotically stimulating material such as nudity. It may be used as foreplay, or as an alternative to sexual penetration. Hugo Ohira, director of marketing for Silvercash, rhetorically asks Who does not like spewing their load on a pretty young face? Reality pornography is professionally made porn which seeks to emulate the style of amateur pornography. The term applies to the depiction of the act rather than the act itself, and so does not include live exhibitions like sex shows and striptease. In some scenes or relationships it may be impossible for consent to be withdrawn in the middle of a scene, or the bottom may have the ability to revoke consent for a relationship as a whole, but not for a particular scene. Often, strong views are expressed with regard to anal sex; it is controversial in various cultures, especially with regard to religion, commonly due to prohibitions against anal sex among gay men or teachings about the procreative purpose of sexual activity. Real enema shots or videos of true medical situations celebrity sex free may violate privacy laws in some countries. Creampie scenes depart from heterosexual pornographic convention in favor of a depiction that more closely mimics sexual intercourse as performed in ordinary life; they have been called the counterimage of facials.一般布置于廠區(qū)最明顯且交通方便的廠正門(mén)附近， 以便于對(duì)外接 洽業(yè)務(wù)。