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href="../index.asp">網(wǎng)站首頁(yè)</a>　|</strong>　詳細內容</td> </tr> <tr> <td style="padding:10px; "> <table width='98%' align="center"> <tr><td height="40" align='center'><h1 style="font-size:15pt; font-weight:bold; ">醫藥廠(chǎng)房?jì)艋闹匾?/h1></td></tr> <tr><td align='right'>【作者/來(lái)自】網(wǎng)站管理員【發(fā)表時(shí)間】2019-3-14 【點(diǎn)擊次數】1330</td></tr> <tr><td style="border:1px #CCCCCC dashed; padding:10px; "> <P style="LIST-STYLE-TYPE: none; FONT-SIZE: medium; OVERFLOW: hidden; FONT-FAMILY: 微軟雅黑, arial; WHITE-SPACE: normal; WORD-SPACING: 0px; TEXT-TRANSFORM: none; FONT-WEIGHT: 400; COLOR: rgb(76,73,72); PADDING-BOTTOM: 0px; FONT-STYLE: normal; TEXT-ALIGN: left; PADDING-TOP: 0px; PADDING-LEFT: 0px; ORPHANS: 2; WIDOWS: 2; MARGIN: 0px; LETTER-SPACING: normal; LINE-HEIGHT: 20px; PADDING-RIGHT: 0px; BACKGROUND-COLOR: rgb(255,255,255); TEXT-INDENT: 21pt; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial"><SPAN style="LIST-STYLE-TYPE: none; FONT-SIZE: 14px; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px">醫藥廠(chǎng)房潔凈室關(guān)鍵技術(shù)主要在于控制塵埃和微生物，作為污染物質(zhì)，微生物是醫藥廠(chǎng)房?jì)艋h(huán)境控制的重中之重。醫藥廠(chǎng)房?jì)艋瘏^的設備、管道內積聚的污染物質(zhì)，可以直接污染藥品，卻毫不影響潔凈度檢測，所以我們說(shuō)：GMP需要空氣凈化技術(shù)，而空氣凈化技術(shù)不代表GMP！凈化等級不適用于表征懸浮粒子的物理性、化學(xué)性、放射性和生命性。不熟悉藥品生產(chǎn)工藝和過(guò)程，不了解造成污染的原因和污染物質(zhì)積聚的場(chǎng)所，不掌握清除污染物質(zhì)的方法和評價(jià)標準，以為潔凈度滿(mǎn)足要求的潔凈室就能生產(chǎn)出高質(zhì)量藥品是GMP認識上的一大誤區�！　　　�</SPAN></P> <P style="LIST-STYLE-TYPE: none; FONT-SIZE: medium; OVERFLOW: hidden; FONT-FAMILY: 微軟雅黑, arial; WHITE-SPACE: normal; WORD-SPACING: 0px; TEXT-TRANSFORM: none; FONT-WEIGHT: 400; COLOR: rgb(76,73,72); PADDING-BOTTOM: 0px; FONT-STYLE: normal; TEXT-ALIGN: left; PADDING-TOP: 0px; PADDING-LEFT: 0px; ORPHANS: 2; WIDOWS: 2; MARGIN: 0px; LETTER-SPACING: normal; LINE-HEIGHT: 20px; PADDING-RIGHT: 0px; BACKGROUND-COLOR: rgb(255,255,255); TEXT-INDENT: 2em; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial"><SPAN style="LIST-STYLE-TYPE: none; FONT-SIZE: 14px; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px">正由于存在主觀(guān)認識上的誤區，在污染控制過(guò)程中的潔凈技術(shù)應用不利，最終出現了有的藥廠(chǎng)投入巨資改造后，藥品質(zhì)量并未明顯提高�！　　�<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px">醫藥潔凈生產(chǎn)廠(chǎng)房的設計、施工、廠(chǎng)房?jì)仍O備設施的制造、安裝，生產(chǎn)用原輔物料、包裝材料質(zhì)量、人凈物凈設施控制程序執行不利等都會(huì )影響產(chǎn)品質(zhì)量�！　×艚�(jīng)過(guò)分析認為：施工方面影響產(chǎn)品質(zhì)量的原因是過(guò)程控制環(huán)節有問(wèn)題，在安裝施工過(guò)程中留有隱患，有如下具體表現：　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 1.凈化空調系統風(fēng)道內壁不干凈、連接不嚴密、漏風(fēng)率過(guò)大；　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 2.彩鋼板圍護結構不嚴密，潔凈室與技術(shù)夾層（吊頂）的密封措施不當、密閉門(mén)不密　　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 3.裝飾型材及工藝管線(xiàn)在潔凈室形成了死角、積塵；　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 4.個(gè)別位置未按照設計要求施工，無(wú)法滿(mǎn)足相關(guān)要求規定；　　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 5.所用密封膠質(zhì)量不過(guò)關(guān)、易脫落、變質(zhì)；<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 6.回、排風(fēng)彩鋼板夾道相通，粉塵從排風(fēng)到進(jìn)入回風(fēng)道；<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 7.工藝純化水、注射水等不銹鋼衛生管道焊接時(shí)內壁焊縫未成型；<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 8.風(fēng)道止回閥動(dòng)作失靈，空氣倒灌造成污染；　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 9.排水系統安裝質(zhì)量不過(guò)關(guān)、管架、附件易積塵；　　<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 10.潔凈室壓差整定不合格，未能滿(mǎn)足生產(chǎn)工藝要求�！　�<BR style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px"> 所以，針對每個(gè)專(zhuān)業(yè)安裝工程公司，<SPAN style="LIST-STYLE-TYPE: none; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; PADDING-LEFT: 0px; MARGIN: 0px; PADDING-RIGHT: 0px; TEXT-INDENT: 28px">廠(chǎng)房?jì)艋?/SPAN>工程施工無(wú)論凈化等級高還是低，都必須為藥廠(chǎng)作好工程部分對污染源進(jìn)入前的過(guò)程控制。</SPAN></P> </td></tr> <tr> <td height="10"></td> </tr> <tr> <td style="border:1px #CCCCCC dashed; padding-left:10px; "> <div align="left">上一篇：<a 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