在(zai)微(wei)生(sheng)物(wu)檢(jian)驗(yan)中(zhong),培(pei)養(yang)基(ji)的(de)質(zhi)量(liang)關(guan)乎(hu)微(wei)生(sheng)物(wu)的(de)檢(jian)驗(yan)結(jie)果(guo)。加(jia)強(qiang)對(dui)培(pei)養(yang)基(ji)的(de)質(zhi)量(liang)管(guan)理(li),能(neng)夠(gou)有(you)效(xiao)提(ti)升(sheng)微(wei)生(sheng)物(wu)檢(jian)驗(yan)結(jie)果(guo)的(de)準(zhun)確(que)性(xing)和(he)科(ke)學(xue)性(xing),因(yin)此需要注重培養基的質量管理工作。
本文從培養基的采購驗收、質量控製、培養基製備後的質量控製以及培養基的滅菌和儲存等環節簡要分析了培養基的質量控製工作。
01.培養基供應商選擇
培(pei)養(yang)基(ji)應(ying)當(dang)從(cong)可(ke)靠(kao)的(de)供(gong)應(ying)商(shang)處(chu)采(cai)購(gou),必(bi)要(yao)時(shi)應(ying)當(dang)對(dui)供(gong)應(ying)商(shang)進(jin)行(xing)評(ping)估(gu)。評(ping)估(gu)應(ying)確(que)定(ding)其(qi)生(sheng)產(chan)工(gong)藝(yi),運(yun)輸(shu)條(tiao)件(jian)是(shi)否(fou)符(fu)合(he)規(gui)定(ding),資(zi)質(zhi)是(shi)否(fou)齊(qi)全(quan),質(zhi)量(liang)保(bao)證(zheng)能(neng)力(li)和(he)生(sheng)產(chan)能(neng)力(li)是(shi)否(fou)符(fu)合(he)需(xu)求(qiu)。如(ru)果(guo)新(xin)增(zeng)培(pei)養(yang)基(ji)供(gong)應(ying)商(shang),應(ying)對(dui)該(gai)廠(chang)家(jia)所(suo)生(sheng)產(chan)的(de)不(bu)同(tong)批(pi)次(ci)的(de)培(pei)養(yang)基(ji)理(li)化(hua)及(ji)微(wei)生(sheng)物(wu)指(zhi)標(biao)進(jin)行(xing)檢(jian)測(ce),並(bing)進(jin)行(xing)審(shen)計(ji)評(ping)估(gu),評(ping)估(gu)合(he)格(ge)後(hou)才(cai)可(ke)以(yi)將(jiang)該(gai)品(pin)牌(pai)納(na)入(ru)合(he)格(ge)供(gong)應(ying)商(shang)名(ming)錄(lu)。
02.培養基初步驗收
在培養基到達實驗室後,應安排專業的人員對培養基進行驗收,首先查看培養基的名稱是否正確、配方是否符合藥典或國標等相應的法規文件的要求、是否臨近有效期、生產批號是否清晰、能否提供商品質檢報告、檢查包裝是否完整,規格、數量是否與采購申請一致。在接收完畢後安排管理人員進行入庫保存,並盡快安排對培養基進行入廠檢測。
03.培養基理化及微生物檢測
培養基的理化指標主要包括pH值、澄明度以及凝膠強度(瓊脂類),培養基的微生物指標一般包括:靈敏度、促生長能力、yizhinengliyijizhishitexing,jipeiyangjishiyongxingjianzha。zhexiezhibiaogongyingshangzaipeiyangjichuchangqianjiuyijingjinxinglejiance,hegehoufangxing。shiyongdanweiyanshoushirengxujinxingpeiyangjishiyongxingjianzha,bingyuchangjiatigongdezhijianbaogaojinxingduibi,kanyubaogaoneirongshifouyizhi。shiyongdanweiyekecaiyongyouzizhidedisanfangjiancebaogao。
04.幹粉培養基儲存
對入庫保存的培養基應張貼標簽,以區分驗收與未驗收的培養基,避免混淆與差錯。在此為大家提供一個簡單的標簽,僅供參考:
使用單位存儲培養基時標簽也可以做編號處理,例如購進100瓶TSB,產品號為11104,其編號為11104-100-1、11104-100-2、...、11104-100-100按照流水號領用培養基,可減少對培養基的盤點,方便管理。
培養基的儲存條件一般為常溫、幹燥、密mi閉bi,當dang然ran不bu同tong供gong應ying商shang的de存cun儲chu條tiao件jian稍shao有you差cha別bie,按an照zhao標biao識shi執zhi行xing即ji可ke。稱cheng量liang後hou應ying及ji時shi旋xuan緊jin瓶ping蓋gai,避bi免mian後hou期qi存cun儲chu因yin空kong氣qi濕shi度du較jiao大da受shou潮chao或huo結jie塊kuai,如ru出chu現xian結jie塊kuai現xian象xiang,該gai瓶ping培pei養yang基ji不bu可ke繼ji續xu使shi用yong。
peiyangjikaipinghouzaichenglianghecunchudeguochengzhonghuibukebimiandexishoukongqizhongdeshuifen,ershuifenhanliangdezengjia,peiyangjideweishengwufuzaikenengyisuizhizengda,jineryingxiangdaoganfenpeiyangjidezhiliang。suoyiganfenpeiyangjizaikaipinghou,yingdingqijinxingfujian,bingduifujianjieguojinxingtongjifenxi,quedingkaipingyouxiaoqi。
如果實驗室所在地區濕度較大(相對濕度高於75%),開瓶後的培養基應采取適宜的保護措施,如果數量較少,可放置於幹燥器內,如果數量較多,可使用封口膜瓶口位置纏繞數匝。
05.培養基配製--稱量
培養基的製備環節,應當嚴格按照培養基配方製備,在培養基的稱量過程中,建議在幹爽、無wu風feng的de區qu域yu或huo者zhe通tong風feng櫃gui中zhong進jin行xing,這zhe樣yang能neng夠gou避bi免mian培pei養yang基ji吸xi潮chao使shi稱cheng量liang結jie果guo不bu準zhun。應ying當dang選xuan擇ze靈ling敏min度du較jiao高gao的de稱cheng重zhong天tian平ping,這zhe樣yang能neng夠gou保bao證zheng稱cheng量liang的de準zhun確que性xing,同tong時shi稱cheng量liang過guo程cheng中zhong要yao選xuan擇ze專zhuan用yong的de稱cheng量liang匙chi,避bi免mian其qi他ta雜za質zhi混hun入ru培pei養yang基ji中zhong。操cao作zuo人ren員yuan應ying當dang對dui稱cheng量liang過guo程cheng進jin行xing詳xiang細xi的de記ji錄lu,記ji錄lu中zhong應ying該gai體ti現xian培pei養yang基ji名ming稱cheng、批號、稱量數量、具體配製方法、製備人姓名日期、複核人姓名日期等信息,方便後期的溯源調查。
06.培養基配製--容器和水
配pei製zhi培pei養yang基ji所suo用yong的de容rong器qi不bu得de影ying響xiang培pei養yang基ji質zhi量liang,一yi般ban為wei玻bo璃li容rong器qi,培pei養yang基ji配pei製zhi所suo用yong的de容rong器qi和he配pei套tao器qi具ju應ying潔jie淨jing,可ke用yong純chun化hua水shui衝chong洗xi玻bo璃li器qi皿min以yi消xiao除chu清qing潔jie劑ji和he外wai來lai物wu質zhi殘can留liu。在zai大da體ti積ji配pei製zhi培pei養yang基ji時shi,企qi業ye也ye可ke根gen據ju自zi己ji的de情qing況kuang采cai用yong不bu鏽xiu鋼gang容rong器qi,建jian議yi專zhuan鍋guo專zhuan用yong,且qie容rong器qi應ying潔jie淨jing。不bu建jian議yi使shi用yong陶tao瓷ci或huo搪tang瓷ci容rong器qi。
培(pei)養(yang)基(ji)用(yong)水(shui)是(shi)培(pei)養(yang)基(ji)製(zhi)備(bei)過(guo)程(cheng)中(zhong)非(fei)常(chang)重(zhong)要(yao)的(de)一(yi)個(ge)物(wu)質(zhi)。不(bu)可(ke)以(yi)使(shi)用(yong)自(zi)來(lai)水(shui),自(zi)來(lai)水(shui)中(zhong)的(de)雜(za)質(zhi)可(ke)能(neng)會(hui)對(dui)檢(jian)驗(yan)結(jie)果(guo)有(you)一(yi)定(ding)的(de)影(ying)響(xiang)。許(xu)多(duo)法(fa)規(gui)在(zai)培(pei)養(yang)基(ji)配(pei)方(fang)中(zhong)采(cai)用(yong)蒸(zheng)餾(liu)水(shui)作(zuo)為(wei)配(pei)製(zhi)用(yong)水(shui),實(shi)際(ji)上(shang)純(chun)化(hua)水(shui)的(de)潔(jie)淨(jing)程(cheng)度(du)不(bu)差(cha)於(yu)蒸(zheng)餾(liu)水(shui),甚(shen)至(zhi)更(geng)優(you),所(suo)以(yi)不(bu)必(bi)單(dan)獨(du)製(zhi)備(bei)蒸(zheng)餾(liu)水(shui),直(zhi)接(jie)使(shi)用(yong)純(chun)化(hua)水(shui)即(ji)可(ke),配(pei)製(zhi)用(yong)純(chun)化(hua)水(shui)應(ying)按(an)藥(yao)典(dian)的(de)要(yao)求(qiu)定(ding)期(qi)進(jin)行(xing)檢(jian)測(ce)。
在zai製zhi備bei過guo程cheng中zhong,可ke先xian加jia入ru培pei養yang基ji,再zai將jiang純chun化hua水shui倒dao入ru容rong器qi內nei,同tong時shi需xu要yao將jiang器qi具ju內nei壁bi上shang的de培pei養yang基ji粉fen末mo一yi同tong帶dai到dao容rong器qi中zhong,然ran後hou根gen據ju說shuo明ming書shu的de要yao求qiu進jin行xing操cao作zuo。涉she及ji到dao大da體ti積ji配pei製zhi後hou要yao分fen裝zhuang的de培pei養yang基ji(例如TSA、TSB、FTM等),分裝前一定要將培養基加熱至完全溶解,避免後續可能會出現的瓶間差異。
07.培養基的滅菌
培pei養yang基ji的de滅mie菌jun過guo程cheng是shi影ying響xiang培pei養yang基ji質zhi量liang的de關guan鍵jian環huan節jie。大da部bu分fen培pei養yang基ji需xu要yao高gao溫wen高gao壓ya濕shi熱re滅mie菌jun,但dan部bu分fen選xuan擇ze性xing培pei養yang基ji由you於yu一yi些xie組zu分fen不bu可ke高gao溫wen高gao壓ya滅mie菌jun,所suo以yi會hui采cai用yong煮zhu沸fei滅mie菌jun,因yin此ci滅mie菌jun前qian應ying閱yue讀du培pei養yang基ji使shi用yong說shuo明ming。
培pei養yang基ji滅mie菌jun應ying采cai用yong驗yan證zheng過guo的de滅mie菌jun程cheng序xu,滅mie菌jun參can數shu應ying通tong過guo無wu菌jun性xing試shi驗yan和he促cu生sheng長chang試shi驗yan的de驗yan證zheng。此ci外wai,對dui高gao溫wen高gao壓ya滅mie菌jun器qi的de蒸zheng汽qi循xun環huan係xi統tong也ye要yao加jia以yi驗yan證zheng,以yi保bao證zheng其qi在zai一yi定ding裝zhuang載zai方fang式shi下xia的de正zheng常chang熱re分fen布bu。溫wen度du緩huan慢man上shang升sheng的de高gao壓ya滅mie菌jun器qi可ke能neng導dao致zhi培pei養yang基ji過guo度du加jia熱re,過guo度du滅mie菌jun會hui影ying響xiang絕jue大da多duo數shu的de細xi菌jun和he真zhen菌jun培pei養yang基ji的de促cu生sheng長chang質zhi量liang。滅mie菌jun器qi中zhong培pei養yang基ji的de容rong積ji和he裝zhuang載zai方fang式shi也ye會hui影ying響xiang加jia熱re的de速su度du。因yin此ci應ying根gen據ju滅mie菌jun培pei養yang基ji的de特te性xing,進jin行xing全quan麵mian的de滅mie菌jun程cheng序xu驗yan證zheng。
煮(zhu)沸(fei)滅(mie)菌(jun)的(de)培(pei)養(yang)基(ji)建(jian)議(yi)現(xian)配(pei)現(xian)用(yong),高(gao)溫(wen)高(gao)壓(ya)濕(shi)熱(re)滅(mie)菌(jun)的(de)培(pei)養(yang)基(ji)可(ke)以(yi)大(da)量(liang)配(pei)製(zhi),在(zai)適(shi)宜(yi)的(de)條(tiao)件(jian)下(xia)儲(chu)存(cun),固(gu)體(ti)培(pei)養(yang)基(ji)滅(mie)菌(jun)後(hou)隻(zhi)允(yun)許(xu)一(yi)次(ci)再(zai)融(rong)化(hua)。滅(mie)菌(jun)後(hou)培(pei)養(yang)基(ji)的(de)儲(chu)存(cun)效(xiao)期(qi)應(ying)進(jin)行(xing)驗(yan)證(zheng)。
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