根據(jù)使用場(chǎng)合的不同,醫(yī)藥用水又分為科研純化水和科研超純水。
醫(yī)藥純化水是將原水經(jīng)蒸餾法、離子交換法、反滲透法或其他適宜的方法值得的制藥用水,不含任何附加劑,可作為配制普通藥物制劑的溶劑或試驗(yàn)用水。在片劑、膠囊、口服液和外用藥劑的生產(chǎn)中,凡與藥品接觸的設(shè)備、容器、內(nèi)包裝和工具,均需用純化水清洗。電導(dǎo)率是純化水的重要指標(biāo),《中國(guó)藥典》(2005版)中對(duì)純化水的電導(dǎo)率有明確要求即小于等于2μs/cm。
一般工藝流程:
● 原水-原水加壓泵-多介質(zhì)過(guò)濾器-活性炭過(guò)濾器-軟水器-精密過(guò)濾器-*級(jí)反滲透 -PH調(diào)節(jié)-中間水箱-第二級(jí)反滲透(反滲透膜表面帶正電荷)-純化水箱-純水泵-紫外線(xiàn)殺菌器- 微孔過(guò)濾器-巴氏消毒—用水點(diǎn) (2005版中國(guó)藥典目前流行工藝)
● 原水-原水加壓泵-多介質(zhì)過(guò)濾器-活性炭過(guò)濾器-軟水器-精密過(guò)濾器-一級(jí)反滲透機(jī)-脫氣膜-------中間水箱-中間水泵-EDI系統(tǒng)-純化水箱-純水泵-紫外線(xiàn)殺菌器-微孔過(guò)濾器-巴氏消毒-用水點(diǎn) (2005版中國(guó)藥典新工藝 )
● 原水-原水加壓泵-多介質(zhì)過(guò)濾器-活性炭過(guò)濾器-軟水器-精密過(guò)濾器-*級(jí)反滲透 -PH調(diào)節(jié)-中間水箱-第二級(jí)反滲透(反滲透膜表面帶正電荷)---RO水箱-RO水泵-—TOC分解器----EDI系統(tǒng)--純化水箱-純水泵-紫外線(xiàn)殺菌器- 微孔過(guò)濾器-巴氏消毒-用水點(diǎn) (中國(guó)藥典注射用水、歐盟和美國(guó)藥典*工藝)
(以上流程根據(jù)用戶(hù)要求和水源特征進(jìn)行調(diào)整,僅供參考)
設(shè)備特點(diǎn):
利用膜工藝生產(chǎn)純化水,不僅可以確保處理后的水*達(dá)到藥典規(guī)定的純化水標(biāo)準(zhǔn),而且對(duì)原水水質(zhì)變化的適應(yīng)能力強(qiáng),避免了傳統(tǒng)方法可能造成的環(huán)境污染,并能有效地降低水處理成本。
常用工藝流程:
● 預(yù)處理系統(tǒng)-反滲透系統(tǒng)-粗混合床-精混合床-紫外線(xiàn)殺菌器-精密過(guò)濾器-用水對(duì)象 (≥15MΩ.CM)(傳統(tǒng)工藝)
● 預(yù)處理-反滲透-EDI裝置-紫外線(xiàn)殺菌器-精密過(guò)濾器-用水對(duì)象(≥15MΩ.CM)(新工藝)
優(yōu)缺點(diǎn)比較: ● *種采用離子交換樹(shù)脂其優(yōu)點(diǎn)在于初投資少,占用的地方少,但缺點(diǎn)就是需要經(jīng)常進(jìn)行離子再生,耗費(fèi)大量酸堿,而且對(duì)環(huán)境有一定的破壞。 ● 第二種采用反滲透作預(yù)處理再配上EDI裝置,這是目前制取超純水,zui環(huán)保用來(lái)制取超純水的工藝,不需要用酸堿進(jìn)行再生便可連續(xù)制取超純水,對(duì)環(huán)境沒(méi)什么破壞性。其缺點(diǎn)在于初投資相對(duì)以上兩種方式過(guò)于昂貴。 |
YSRO-M系列醫(yī)藥反滲透純水設(shè)備,采用二級(jí)反滲透水質(zhì)處理或一級(jí)反滲透+混床處理,該設(shè)備在嚴(yán)格執(zhí)行IS9001質(zhì)量體系標(biāo)準(zhǔn)的前提下,采用世界上的反滲透膜元件,壓力容器、高壓泵,配以合理而高效的前處理設(shè)備及后處理脫鹽設(shè)備,使出水的水質(zhì)*符合GMP標(biāo)準(zhǔn),系統(tǒng)設(shè)備手動(dòng)、自動(dòng)沖洗、無(wú)水停機(jī),高低壓保護(hù)及液位控制等功能。
YSRO-M series of phamaceutical reverse osmosis pure water equipments are applicalbe for water consumption requiements on various pharmaceutical preparations,medicine confetions,transfusions and injections.
YSRO-M series of phamaceutical reverse osmosis pure water equipments are attached with 2-stage reverse osmosis water quality treatment or 1-stage reverse osmosis + blending bed treatment. in the equipment, the most advanced reverse osmosis film components,pressere vessels and high-pressure pumps in the word are applied attached by reasonable and highly efficient prophase treatment equipments, subsequent treatment fine desalinization equipents strictly according to ISO-9001 International Quality Management System, in order to make outgoing water quality compley in accordance with GMP standard,In the system, functions such as manual operation,automatic cleaning, no-water halt,high and low pressure protection and level control are available.
廣泛使用于:
*大輸液、針劑、口服液等制劑生產(chǎn)
*原料藥的提取洗滌、針劑、膠囊生產(chǎn)、
**及護(hù)理液的生產(chǎn)
*醫(yī)院血透室、生化分析室、手術(shù)室無(wú)菌水
*多效蒸餾水機(jī)原料水、洗瓶水
*化妝品工藝用水、洗滌用品用水
*生化藥物制品、診斷試劑液、針劑、口服液等制劑生產(chǎn)
IDELY APPLIED IN:
*Production of medicines such as large amount transfusion, injection and oral liquids etc.
*Raw materials distillatuon and cleaning, production of injections and capsules
*Production of eyedrops and nursing liquids
*Asepsis water for blood diaysis rooms,bio-chemical analysis rooms and operating rooms in hospitals
*Raw material water and bottle cleaning water for multi-purpose distilled water machine
*Water of cosmetics and cleaning agents
*Production of medicines such as bioppharmaceutical products,diagnosis reagent liquids,inquids and so on
*Raw materials distillation and cleaning,production of injections and capsules.