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/>相關(guān)文章</p><span>RELATED ARTICLES</span><em></em></div> <div id="3s4bxmrupv1" class="NyXgwz_List"> <dl> </dl> </div> </div>  </div> <script type="text/javascript" src="/Skins/610567/js/pt_js.js"></script> <div id="3s4bxmrupv1" class="NyProDetail_Right"> <div id="3s4bxmrupv1" class="NyProDetail_Con"> <div id="3s4bxmrupv1" class="NyProDetail_Tit"><span>詳細(xì)介紹</span><a href="#cpzx">在線留言</a><div id="3s4bxmrupv1" class="clear"></div></div> <div id="3s4bxmrupv1" class="ProDetailText"> <div><span style="font-size: 14px;">　　注射用水是一種特殊的制藥用水，它需要通過特定設(shè)計(jì)的蒸餾器進(jìn)行蒸餾，并且經(jīng)過膜過濾制備而成。注射用水的制備、儲(chǔ)存和分配系統(tǒng)必須能夠防止微生物的滋生和污染，以確保水質(zhì)達(dá)到設(shè)定的質(zhì)量標(biāo)準(zhǔn)。<strong>GMP 注射水設(shè)備</strong>的設(shè)計(jì)和使用必須遵循嚴(yán)格的規(guī)范，以確保生產(chǎn)的注射用水滿足藥品生產(chǎn)中的高標(biāo)準(zhǔn)要求，從而保障藥品的安全性和有效性。</span></div><div><span style="font-size: 14px;">　　中國藥典純化水標(biāo)準(zhǔn)規(guī)定純化水設(shè)備需要設(shè)計(jì)良好的消毒和殺菌方式，從而達(dá)到有效控制系統(tǒng)微生物負(fù)荷的目的。除此之外，網(wǎng)管系統(tǒng)維持湍流狀態(tài)，系統(tǒng)設(shè)計(jì)避免死角，采用熱消毒和化學(xué)消毒方式均可有效控制微生物。純化水系統(tǒng)需要通過驗(yàn)證。通過在線或者離線方法進(jìn)行水質(zhì)質(zhì)量的監(jiān)測(cè)，在周期內(nèi)按照既定程序進(jìn)行系統(tǒng)維護(hù)，定期對(duì)系統(tǒng)各個(gè)組成部分進(jìn)行檢查，確保純化水系統(tǒng)穩(wěn)定運(yùn)行，產(chǎn)水符合預(yù)期用途。<br/><br type="_moz"/></span></div><div><span style="font-size: 14px;">　　一、中國藥典2020版純化水標(biāo)準(zhǔn)：</span></div><div><span style="font-size: 14px;">　　1、性狀：無色的澄清液體，無臭（這表示水應(yīng)該是透明的，沒有任何顏色，且沒有外來的氣味）</span></div><div><span style="font-size: 14px;">　　2、酸堿度：符合要求（純化水的pH值應(yīng)在一定的范圍內(nèi)，以滿足特定的使用要求，但具體范圍在此處未給出）</span></div><div><span style="font-size: 14px;">　　3、硝酸鹽：≤0.000006%（防止水中硝酸鹽過高而對(duì)人體健康造成危害）</span></div><div><span style="font-size: 14px;">　　4、亞硝酸鹽：≤0.000002%（亞硝酸鹽通常由水中的細(xì)菌活動(dòng)產(chǎn)生，高含量可能對(duì)人體有害）</span></div><div><span style="font-size: 14px;">　　5、氨：≤0.00003%（氨的存在可能是由于水處理過程中化學(xué)品的使用或是由于有機(jī)物質(zhì)的分解）</span></div><div><span style="font-size: 14px;">　　6、電導(dǎo)率：≤4.3μS/cm（20℃）；≤5.1μS/cm（25℃）（電導(dǎo)率是衡量水中離子含量的一個(gè)指標(biāo)）</span></div><div><span style="font-size: 14px;">　　7、總有機(jī)碳(TOC)：≤0.5mg/L（總有機(jī)碳反映了水中有機(jī)物的含量，標(biāo)準(zhǔn)規(guī)定不超過0.5mg/L，說明水中有機(jī)物含量極低）</span></div><div><span style="font-size: 14px;">　　8、易氧化物：符合要求（與總有機(jī)碳任選一項(xiàng)，該指標(biāo)與總有機(jī)碳任選一項(xiàng)進(jìn)行檢測(cè)，具體要求取決于實(shí)際的應(yīng)用需求）</span></div><div><span style="font-size: 14px;">　　9、不揮發(fā)物：1mg/100mL（在100mL的水中，不揮發(fā)物的質(zhì)量不應(yīng)超過1mg，這表明水中幾乎不含有任何不易揮發(fā)的物質(zhì)）</span></div><div><span style="font-size: 14px;">　　10、重金屬：≤0.00001%（水中的重金屬含量不應(yīng)超過0.00001%，這是為了確保水中不含有對(duì)人體有害的重金屬元素）</span></div><div><span style="font-size: 14px;">　　11、微生物限度：需氧菌總數(shù)≤100CFU/mL（純化水中的需氧菌總數(shù)不應(yīng)超過100CFU/mL，這個(gè)嚴(yán)格的限制是為了確保水的安全性，防止微生物污染）<br/><br type="_moz"/></span></div><div><span style="font-size: 14px;">　　二、</span><span style="font-size: 14px;">注射水設(shè)備</span><span style="font-size: 14px;">介紹</span></div><div><span style="font-size: 14px;">　　根據(jù)不同地區(qū)的原水水質(zhì)，為客戶提供因地制宜的制水工藝設(shè)計(jì)，有效控制微生物，最大限度的減少其他產(chǎn)品或生產(chǎn)過程中所產(chǎn)生的交叉污染。<br/><br type="_moz"/></span></div><div><span style="font-size: 14px;">　　三、注射用水是藥品生產(chǎn)中的重要組分，其質(zhì)量直接關(guān)系到最終產(chǎn)品的安全性和有效性。因此，注射用水的制備、儲(chǔ)存和輸送系統(tǒng)必須嚴(yán)格遵循GMP（Good Manufacturing Practice）規(guī)范。以下是注射用水設(shè)備的核心特征：</span></div><div><span style="font-size: 14px;">　　1、GMP合規(guī)性：設(shè)備的制造和設(shè)計(jì)符合GMP的驗(yàn)證要求，確保了制藥用水系統(tǒng)的合規(guī)性和可靠性。</span></div><div><span style="font-size: 14px;">　　2、高性能材料：所有關(guān)鍵部件均選用符合驗(yàn)證標(biāo)準(zhǔn)的材料，保證了設(shè)備的長期穩(wěn)定運(yùn)行和性能。</span></div><div><span style="font-size: 14px;">　　3、膜組件優(yōu)化：通過優(yōu)化膜組件的排列，大幅提升了原水的利用效率，降低了水資源的浪費(fèi)。</span></div><div><span style="font-size: 14px;">　　4、在線檢測(cè)：每個(gè)處理單元都配備了取樣點(diǎn)，實(shí)現(xiàn)在線水質(zhì)監(jiān)測(cè)，確保不合格的水不會(huì)流入后續(xù)處理環(huán)節(jié)。</span></div><div><span style="font-size: 14px;">　　5、智能化控制：整套設(shè)備采用PLC和觸摸屏進(jìn)行全自動(dòng)智能化控制，能夠?qū)崿F(xiàn)全程水質(zhì)在線監(jiān)測(cè)，并支持遠(yuǎn)程監(jiān)控與操作，提高了操作的便捷性和系統(tǒng)的響應(yīng)速度。</span></div><div><span style="font-size: 14px;">　　6、清洗消毒：RO膜和EDI組件采用化學(xué)藥劑進(jìn)行定期清洗和消毒，保持了系統(tǒng)的清潔和高效運(yùn)行。</span></div><div><span style="font-size: 14px;">　　7、產(chǎn)水質(zhì)量：設(shè)備的內(nèi)控標(biāo)準(zhǔn)為產(chǎn)水電導(dǎo)率不超過2μs/cm（25℃），而藥典標(biāo)準(zhǔn)規(guī)定電導(dǎo)率應(yīng)不超過5.1μs/cm（25℃），顯示出設(shè)備在質(zhì)量控制上的嚴(yán)格程度。</span></div><div><span style="font-size: 14px;">　　8、文件提供：為客戶提供完整的電子版驗(yàn)證文件，并且這些文件可以根據(jù)需要進(jìn)行修改，以便滿足特定的驗(yàn)證要求。<br/><br type="_moz"/></span></div><div><span style="font-size: 14px;">　　<strong>GMP 注射水設(shè)備</strong>的設(shè)計(jì)、制造和運(yùn)行都嚴(yán)格遵守GMP規(guī)范，以確保生產(chǎn)的注射用水達(dá)到藥品生產(chǎn)中的高標(biāo)準(zhǔn)，保障最終產(chǎn)品的質(zhì)量。</span></div> 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