技(ji)術(shu)文章(zhang)
當(dang)前(qian)位(wei)置:首頁 > 技(ji)術(shu)文章(zhang)
藥(yao)品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)校準(zhun)規(gui)範1範(fan)圍本(ben)規(gui)範(fan)適(shi)用(yong)於溫度(du)範(fan)圍(0~65)℃、相(xiang)對(dui)濕(shi)度(du)範(fan)圍(10~95)%、照(zhao)度(du)範(fan)圍(0~7000)lx、紫(zi)外(wai)輻(fu)射(she)照(zhao)度(du)範(fan)圍(0~300)μW/cm2的藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)(以下簡稱試驗箱(xiang))的校準(zhun)。2引(yin)用(yong)文件(jian)本規(gui)範引(yin)用(yong)了(le)下列(lie)文件(jian):JJG245光(guang)照(zhao)度(du)計JJG879紫(zi)外(wai)...
壹、開機前準(zhun)備(bei)低(di)溫冷(leng)藏箱(xiang)放置(zhi)於通(tong)風(feng)陰(yin)涼處(chu),背部(bu)/兩(liang)側留≥10cm散(san)熱空(kong)間,地(di)面(mian)平(ping)整(zheng)。用獨立(li)接地(di)220V插座(zuo),電(dian)源(yuan)線(xian)無(wu)破損。中性洗(xi)滌劑(ji)清潔(jie)內(nei)外(wai)壁及(ji)門(men)封(feng)條(tiao),晾(liang)幹後(hou)空(kong)載(zai)運(yun)行4-6小(xiao)時(shi)(超低(di)溫箱(xiang)12-24小(xiao)時(shi)),待(dai)溫(wen)度(du)穩(wen)定(ding)後放(fang)物(wu)品(pin)。二、溫(wen)度(du)設(she)定(ding)與開(kai)機(ji)通(tong)電(dian)開(kai)機(ji)後(hou)進入溫控(kong)界面(mian),按物(wu)品(pin)設(she)定(ding)溫度(du):藥(yao)品(pin)/疫(yi)苗(miao)2℃~8℃,普(pu)通(tong)試(shi)劑(ji)-18℃~-20℃,生物(wu)樣(yang)本-40℃~-86℃。醫用/科研用需(xu)設密碼(ma)防誤操(cao)作(zuo),啟用超溫(wen)、斷(duan)電(dian)等(deng)報(bao)警功能,定(ding)期用(yong)第(di)三(san)方(fang)探頭校準(zhun)。三(san)、物(wu)品(pin)存取規(gui)範(fan)分(fen)區(qu)密封(feng)存放,裝(zhuang)載(zai)量≤80...
在(zai)藥(yao)品(pin)研(yan)發(fa)和(he)生產過(guo)程中(zhong),穩定(ding)性考察是確(que)保藥品(pin)質(zhi)量、安全(quan)性(xing)和(he)有效(xiao)性的關鍵環(huan)節。大(da)型(xing)藥(yao)品(pin)穩(wen)定(ding)性考察室(shi)通(tong)過(guo)模擬不(bu)同環(huan)境條件(jian),對藥(yao)品(pin)進(jin)行長期和(he)加(jia)速穩定(ding)性測試,以評(ping)估藥品(pin)在(zai)實(shi)際儲存和(he)使用過程中(zhong)的穩定(ding)性。其(qi)中,溫度(du)、濕(shi)度(du)和(he)光(guang)照(zhao)是影(ying)響(xiang)藥(yao)品(pin)穩(wen)定(ding)性的主(zhu)要(yao)因素,對(dui)藥品(pin)的質(zhi)量和(he)有效(xiao)期有(you)著深遠(yuan)的影響(xiang)。壹、溫度(du)對(dui)藥(yao)品(pin)穩(wen)定(ding)性的影響(xiang)溫(wen)度(du)是影(ying)響(xiang)藥(yao)品(pin)穩(wen)定(ding)性的首要(yao)因素。大(da)多數藥(yao)品(pin)的化學反應速率(lv)會(hui)隨(sui)著溫度(du)的升高(gao)而(er)顯著(zhu)增(zeng)加(jia)。在(zai)較(jiao)高(gao)的溫度(du)下(xia),藥(yao)品(pin)中(zhong)的活性成(cheng)分可(ke)能會(hui)發(fa)生分解(jie)、氧化或聚(ju)合等(deng)反應,導致藥品(pin)的療效(xiao)降低(di)或失(shi)效(xiao)。...
在(zai)科研質(zhi)檢(jian)、產品(pin)生產等(deng)諸(zhu)多領(ling)域(yu),PM2.5恒(heng)溫恒濕(shi)試驗室(shi)宛如(ru)壹位嚴苛的“環(huan)境考官(guan)”,精(jing)準(zhun)模擬各(ge)類溫濕(shi)度(du)條(tiao)件(jian),為(wei)材(cai)料性能、產品(pin)質(zhi)量把關(guan)。可(ke)壹旦它(ta)“鬧(nao)脾氣(qi)”出現故(gu)障(zhang),實(shi)驗進(jin)程便(bian)陷入(ru)僵(jiang)局。別著(zhe)急(ji),這(zhe)份避坑(keng)指南奉(feng)上,助妳(ni)快(kuai)速攻克(ke)5大(da)高(gao)頻故障(zhang)。壹、溫度(du)失(shi)控(kong):偏離設定(ding)值,波(bo)動異(yi)常(chang)根(gen)源(yuan)探(tan)尋(xun):加(jia)熱元件(jian)“罷(ba)工”是常(chang)見誘因,如電(dian)熱(re)絲(si)長期使用老化斷(duan)裂,或是固(gu)態繼(ji)電(dian)器損壞(huai),致使電(dian)流(liu)無(wu)法(fa)正(zheng)常(chang)傳輸,熱量供應中斷(duan);制(zhi)冷(leng)系統(tong)也常(chang)“掉(diao)鏈子(zi)”,壓縮(suo)機故障、制冷(leng)劑泄(xie)漏(lou),讓降溫(wen)有(you)心無力。此(ci)外(wai),傳感(gan)器失(shi)靈會(hui)誤導(dao)控(kong)制系(xi)...
在(zai)藥(yao)品(pin)研(yan)發(fa)、生產與質(zhi)量控(kong)制領(ling)域(yu),綜(zong)合藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)扮演著(zhe)至(zhi)關重(zhong)要(yao)的角(jiao)色。它(ta)如(ru)同壹位精(jing)準(zhun)的“藥品(pin)質(zhi)量守門(men)員(yuan)”,確(que)保藥品(pin)在(zai)各(ge)種(zhong)環(huan)境條件(jian)下都(dou)能保持(chi)其應有的療效(xiao)與安(an)全(quan)性。藥(yao)品(pin)的穩定(ding)性是衡(heng)量(liang)其(qi)質(zhi)量的關鍵指(zhi)標(biao)之壹。從研發(fa)階(jie)段的配方(fang)篩選,到(dao)生產環(huan)節的工藝優(you)化,再到(dao)上市後的質(zhi)量監(jian)控(kong),穩定(ding)性測試貫穿(chuan)藥品(pin)的整(zheng)個(ge)生命周期(qi)。綜(zong)合藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)能夠模擬藥(yao)品(pin)在(zai)實(shi)際儲存、運(yun)輸和(he)使用過程中(zhong)可(ke)能遇到(dao)的各(ge)種(zhong)環(huan)境條件(jian),如不(bu)同的溫度(du)、濕(shi)度(du)、光(guang)照(zhao)強(qiang)度(du)等(deng)。通(tong)過(guo)在(zai)這(zhe)些設定(ding)條件(jian)下對藥品(pin)進(jin)行長期或短期(qi)的穩定(ding)性試(shi)驗,研(yan)究人(ren)...
在(zai)藥(yao)品(pin)研(yan)發(fa)、生產以及(ji)質(zhi)量控(kong)制的過程中(zhong),綜(zong)合藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)扮演著(zhe)極(ji)為關(guan)鍵(jian)的角(jiao)色。它(ta)能夠模擬出各(ge)種(zhong)不同的環(huan)境條件(jian),從而(er)對藥(yao)品(pin)在(zai)不(bu)同環(huan)境下的穩定(ding)性進(jin)行測試,這(zhe)對(dui)於確(que)保藥品(pin)的安全性(xing)、有效(xiao)性和(he)質(zhi)量至關(guan)重(zhong)要(yao)。然而(er),面(mian)對市場上(shang)眾(zhong)多品(pin)牌(pai)和(he)型(xing)號(hao)的綜(zong)合藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang),如何(he)選購到(dao)合適(shi)的產品(pin),以及(ji)如(ru)何(he)充分(fen)發(fa)揮(hui)其(qi)在(zai)實(shi)際應用中(zhong)的價值(zhi),是許(xu)多(duo)企業和(he)科研機構(gou)需(xu)要(yao)考慮(lv)的問題。壹、選購要(yao)點(壹)售(shou)後(hou)良好(hao)的售(shou)後(hou)服務可以在(zai)設(she)備(bei)出現故(gu)障(zhang)時(shi)及(ji)時(shi)得(de)到(dao)維(wei)修(xiu)和(he)保養(yang),減少設(she)備(bei)停(ting)機時(shi)間(jian),保障實(shi)驗的連續性(xing)。在(zai)購(gou)買前(qian),可以向廠家...
高(gao)低(di)溫沖擊試(shi)驗箱(xiang)的操作(zuo)需(xu)遵循“試(shi)驗前(qian)準(zhun)備(bei)-參(can)數設(she)定(ding)-樣(yang)品(pin)放(fang)置-運(yun)行監(jian)控(kong)-試驗收(shou)尾”的流程,維(wei)護(hu)則(ze)涵蓋(gai)日常(chang)、定(ding)期及(ji)特(te)殊工(gong)況(kuang)維(wei)護(hu),以下是詳(xiang)細(xi)指(zhi)南:操(cao)作(zuo)指南試(shi)驗前(qian)準(zhun)備(bei)設(she)備(bei)檢(jian)查:確(que)認設(she)備(bei)放(fang)置(zhi)環(huan)境溫度(du)15-30℃、濕(shi)度(du)≤85%RH,周圍無(wu)腐(fu)蝕(shi)氣(qi)體和(he)強(qiang)幹擾(rao),底部通(tong)風(feng)口(kou)無堵(du)塞;檢(jian)查外(wai)殼無(wu)破(po)損(sun),箱(xiang)門(men)密封(feng)膠(jiao)條(tiao)彈(dan)性(xing)良好(hao),制(zhi)冷(leng)管路(lu)無(wu)泄(xie)漏(lou),水(shui)箱(xiang)水(shui)位達“高(gao)”刻度(du)線(xian),且接地(di)電(dian)阻(zu)≤50Ω。樣(yang)品(pin)處(chu)理:清(qing)理(li)樣(yang)品(pin)表面(mian)灰(hui)塵、油(you)汙(wu),通(tong)過(guo)拍(pai)照(zhao)、測量尺寸等(deng)記(ji)錄(lu)初(chu)始狀態;確(que)保樣(yang)品(pin)尺寸不(bu)阻(zu)礙風(feng)道,小(xiao)型(xing)樣(yang)品(pin)需(xu)準(zhun)備(bei)夾(jia)具(ju)固(gu)定(ding)。參...
低(di)溫冷(leng)藏箱(xiang)是實(shi)驗室(shi)、醫療場所(suo)及(ji)工(gong)業(ye)領(ling)域(yu)中(zhong)用於存儲生物(wu)樣(yang)本、疫苗(miao)、藥(yao)品(pin)及(ji)特(te)殊材(cai)料的關鍵設(she)備(bei)。正(zheng)確(que)設定(ding)溫度(du)和(he)合理存放物(wu)品(pin)不(bu)僅能保障存儲質(zhi)量,還能延(yan)長設備(bei)壽(shou)命。以下從溫度(du)設(she)定(ding)、物(wu)品(pin)分(fen)類存放、操(cao)作(zuo)註意(yi)事(shi)項(xiang)三(san)方(fang)面(mian)展開規(gui)範說明。壹、溫度(du)設(she)定(ding)規範(fan)根(gen)據(ju)存儲物(wu)品(pin)類型(xing)設(she)定(ding)溫度(du)生物(wu)樣(yang)本/疫苗(miao):通(tong)常(chang)需(xu)-20℃至-80℃超低(di)溫環(huan)境(如-70℃保存病毒(du)樣(yang)本),需(xu)選擇(ze)醫用級(ji)低(di)溫冷(leng)藏箱(xiang)並(bing)配備(bei)獨立(li)溫(wen)度(du)記(ji)錄(lu)儀。藥品(pin)/試(shi)劑:多數藥(yao)品(pin)需(xu)2℃至8℃冷(leng)藏(如胰(yi)島(dao)素、抗(kang)生素),部(bu)分特殊藥(yao)品(pin)(如(ru)凍(dong)幹粉(fen))可(ke)能需(xu)-20℃以下環(huan)...
藥品(pin)的穩定(ding)性直(zhi)接影響(xiang)其(qi)安(an)全(quan)性和(he)有效(xiao)性,因(yin)此(ci)需(xu)要(yao)在(zai)不(bu)同的環(huan)境條件(jian)下進(jin)行(xing)嚴格(ge)的測試。可(ke)程(cheng)式藥(yao)品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)作(zuo)為壹種實驗室(shi)設(she)備(bei),能夠模擬各(ge)種(zhong)實際儲存環(huan)境條件(jian),為藥(yao)品(pin)穩(wen)定(ding)性研(yan)究提供了(le)強(qiang)大(da)的支持(chi)。可程式藥品(pin)穩(wen)定(ding)性試(shi)驗箱(xiang)的核心功能是通(tong)過(guo)精(jing)確(que)控(kong)制溫(wen)度(du)、濕(shi)度(du)和(he)光(guang)照(zhao)等(deng)環(huan)境因素,模擬藥(yao)品(pin)在(zai)實(shi)際儲存過程(cheng)中可(ke)能遇到(dao)的各(ge)種(zhong)條件。藥品(pin)在(zai)儲存過程(cheng)中會(hui)受到(dao)多種(zhong)環(huan)境因素的影響(xiang),包(bao)括(kuo)溫(wen)度(du)變(bian)化、濕(shi)度(du)波(bo)動、光(guang)照(zhao)強(qiang)度(du)以及(ji)空(kong)氣(qi)中的氧氣(qi)含(han)量(liang)等(deng)。這(zhe)些因素都(dou)可(ke)能導致藥品(pin)的化學成(cheng)分發(fa)生變(bian)化,從而(er)影響(xiang)其(qi)質(zhi)量和(he)有效(xiao)期。例(li)如,高(gao)溫和(he)...
藥物(wu)穩定(ding)性考察箱(xiang)作(zuo)為壹種檢(jian)測設備(bei)為(wei)藥(yao)品(pin)質(zhi)量檢(jian)測提供(gong)了(le)強(qiang)有力(li)的保障。它(ta)不(bu)僅(jin)能夠模擬各(ge)種(zhong)環(huan)境條件(jian),還能精(jing)確(que)控(kong)制這(zhe)些條(tiao)件,從而(er)幫助研究(jiu)人(ren)員(yuan)和(he)生產人(ren)員(yuan)全面(mian)了(le)解(jie)藥品(pin)在(zai)不(bu)同環(huan)境下的穩定(ding)性,確(que)保藥品(pin)的安全性(xing)和(he)有效(xiao)性。壹、重要(yao)作(zuo)用藥(yao)品(pin)的質(zhi)量和(he)穩定(ding)性直(zhi)接影響(xiang)到(dao)患者(zhe)的用藥安(an)全和(he)治(zhi)療效(xiao)果。在(zai)藥(yao)品(pin)的研發(fa)和(he)生產過(guo)程中(zhong),藥物(wu)穩定(ding)性箱(xiang)通(tong)過(guo)模擬不(bu)同的環(huan)境條件(jian),幫助研究(jiu)人(ren)員(yuan)和(he)生產人(ren)員(yuan)全面(mian)了(le)解(jie)藥品(pin)在(zai)各(ge)種(zhong)條件下的穩定(ding)性。這(zhe)種設備(bei)可(ke)以精(jing)確(que)控(kong)制溫(wen)度(du)、濕(shi)度(du)、光(guang)照(zhao)等(deng)參(can)數,確(que)保實驗條(tiao)件的穩定(ding)性和(he)可重(zhong)復性(xing)。通(tong)過(guo)這(zhe)些(xie)實驗,研(yan)究...
在(zai)藥(yao)品(pin)研(yan)發(fa)、生產和(he)質(zhi)量控(kong)制的各(ge)個(ge)環(huan)節中,藥(yao)物(wu)穩定(ding)性考察箱(xiang)扮演著(zhe)至(zhi)關重(zhong)要(yao)的角(jiao)色。它(ta)不(bu)僅(jin)是藥(yao)品(pin)質(zhi)量的守護(hu)者(zhe),更是確(que)保藥品(pin)安(an)全性和(he)有效(xiao)性的關鍵設(she)備(bei)。通(tong)過(guo)精(jing)確(que)控(kong)制和(he)模擬各(ge)種(zhong)環(huan)境條件(jian),藥物(wu)穩定(ding)性箱(xiang)為藥(yao)品(pin)的穩定(ding)性測試提(ti)供(gong)了(le)可靠(kao)的平(ping)臺,從而(er)幫助企業(ye)和(he)研究(jiu)機構(gou)在(zai)藥(yao)品(pin)全(quan)生命周期(qi)中(zhong)實現質(zhi)量把控(kong)。壹、作(zuo)用藥(yao)品(pin)的質(zhi)量和(he)穩定(ding)性直(zhi)接影響(xiang)到(dao)患者(zhe)的用藥安(an)全和(he)治(zhi)療效(xiao)果。在(zai)藥(yao)品(pin)的研發(fa)和(he)生產過(guo)程中(zhong),藥物(wu)穩定(ding)性箱(xiang)通(tong)過(guo)模擬不(bu)同的環(huan)境條件(jian),幫助研究(jiu)人(ren)員(yuan)和(he)生產人(ren)員(yuan)全面(mian)了(le)解(jie)藥品(pin)在(zai)各(ge)種(zhong)條件下的穩定(ding)性。這(zhe)種設備(bei)可(ke)以精(jing)確(que)控(kong)制溫(wen)度(du)...
電(dian)熱(re)鼓(gu)風(feng)幹燥(zao)箱(xiang)作(zuo)為實(shi)驗室(shi)和(he)工業(ye)場景(jing)中高(gao)頻使用的設備(bei),其(qi)穩(wen)定(ding)性和(he)壽(shou)命直(zhi)接影響(xiang)實(shi)驗精(jing)度(du)與生產效(xiao)率(lv)。通(tong)過(guo)系(xi)統(tong)性維(wei)護(hu)可降低(di)故障(zhang)率(lv)30%以上,以下是6大(da)核心技(ji)巧:1.深度(du)清(qing)潔(jie):從表面(mian)到(dao)內(nei)部(bu)的全面(mian)防護(hu)箱(xiang)體清(qing)潔(jie):每日使用後,用軟布擦(ca)拭箱(xiang)體表面(mian),防止表層脫(tuo)漆導(dao)致金屬腐蝕(shi)。對(dui)於(yu)內(nei)膽(dan),需(xu)每周清(qing)理(li)殘留樣(yang)品(pin)和(he)灰(hui)塵,避免腐(fu)蝕(shi)性(xing)物(wu)質(zhi)(如化學試(shi)劑(ji))長期附(fu)著。案(an)例:某(mou)實(shi)驗室(shi)因(yin)未及(ji)時(shi)清(qing)理內(nei)膽(dan)酸液殘留,導(dao)致不銹鋼內(nei)膽(dan)局部(bu)腐蝕(shi)穿(chuan)孔,維(wei)修(xiu)成(cheng)本超5000元。通(tong)風(feng)系(xi)統(tong)維(wei)護(hu):每月清(qing)理通(tong)風(feng)口(kou)和(he)過濾(lv)器,確(que)保風道(dao)暢(chang)通(tong)。若發(fa)現風(feng)...
在(zai)藥(yao)品(pin)的研發(fa)、生產和(he)質(zhi)量控(kong)制過(guo)程中(zhong),藥物(wu)穩定(ding)性考察是確(que)保藥品(pin)安(an)全性和(he)有效(xiao)性的重要(yao)環(huan)節。而(er)藥物(wu)穩定(ding)性考察箱(xiang)作(zuo)為這(zhe)壹環(huan)節的關鍵設(she)備(bei),其(qi)準(zhun)確(que)的控(kong)溫控(kong)濕(shi)功能,為藥(yao)品(pin)的安全性(xing)提供了(le)有力(li)保障。藥(yao)品(pin)的穩定(ding)性受到(dao)多種(zhong)因(yin)素的影響(xiang),其(qi)中(zhong)溫(wen)度(du)和(he)濕(shi)度(du)是最(zui)為(wei)關(guan)鍵的環(huan)境因素。不(bu)同的藥品(pin)在(zai)不(bu)同的溫濕(shi)度(du)條(tiao)件(jian)下(xia),其(qi)化學成(cheng)分、物(wu)理性質(zhi)以及(ji)生物(wu)活性等(deng)都(dou)可(ke)能發(fa)生改變(bian)。例如(ru),某(mou)些(xie)藥(yao)物(wu)在(zai)高(gao)溫高(gao)濕(shi)的環(huan)境下可(ke)能會(hui)加(jia)速分解(jie),導致藥效(xiao)降低(di)甚至(zhi)產生有害(hai)的降解(jie)產物(wu);而(er)另(ling)壹些藥物(wu)則(ze)可能在(zai)幹燥(zao)的環(huan)境中變(bian)得不(bu)穩(wen)定(ding)。因此(ci),為(wei)了(le)確(que)保藥品(pin)在(zai)儲...
關註(zhu)微信(xin)