GMP潔凈車間設(shè)計要求及總體評估

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

    1、對周圍環(huán)境的要求現(xiàn)代化的潔凈車間不僅要求企業(yè)內(nèi)部廠容廠貌和生產(chǎn)車間的建設(shè)符合 GMP 的要求，同時要求工廠周圍的環(huán)境符合特定要求，因此在建廠之前對建廠地址進行環(huán)境評估很有必要。

    1.1、所建廠房對環(huán)境要求的評估即鑒定該地區(qū)是否符合建廠要求。評估內(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，評估三通情況即通路、通電、通水情況。

    ①、對空氣質(zhì)量的評估了解擬建廠區(qū)周圍大氣環(huán)境質(zhì)量現(xiàn)狀，要求擬建廠房周圍空氣新鮮，通過空氣過濾器來凈化空氣，做到無污染源，少塵埃。

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

    ③、對廠區(qū)周邊地區(qū)通路、通電、通水情況進行評估。

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

    ①、對空氣質(zhì)量影響的評估 對排放有毒有害氣體或粉塵的生產(chǎn)廠，要經(jīng)處理達到當?shù)貥藴�，而且還不能建在城鎮(zhèn)居民區(qū)的上風向，宜遠離居民區(qū)。

    ②、對水資源影響的評估 對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圍， 比如水庫，城鎮(zhèn)居民取水的河流、地下水。并且要了解當?shù)匚鬯�排放的情況和流向，經(jīng)過處理，達標排放。

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

    2、凈化生產(chǎn)廠建設(shè)的總體規(guī)劃：潔凈車間建設(shè)的總體規(guī)劃不僅影響到整個廠區(qū)布局是否合理， 同時也影響到生產(chǎn)廠以后的發(fā)展，所以規(guī)劃時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。具體布局首先應(yīng)該了解當?shù)爻Ｄ甑娘L向狀況，即當?shù)仫L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)車間、庫房、通用工程。潔凈車間要考慮所建車間的性質(zhì)及潔凈級別的要求。精制、灌裝生產(chǎn)車間對環(huán)境空氣潔凈度要求相對較高，且車間不排放有毒有害氣體和粉塵，一般布置于常年的上風向；萃取生產(chǎn)車間對環(huán)境空氣潔凈度要求相對較低，且車間間歇排放有害氣體和粉塵，一般布置于高潔凈度車間的下風向；預(yù)處理車間由于產(chǎn)生粉塵和噪音，一般布置在常年的下風向；

    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)車間的下風向。行政區(qū)包括供銷部門和管理部門， 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附近， 以便于對外接 洽業(yè)務(wù)。