产(Chan)品(Pin)中(Zhong)心(Xin)
产(Chan)品(Pin)分(Fen)类(Lei)
PI2114 气(Qi)体(Ti)浓(Nong)度(Du)分(Fen)析(Xi)仪(Yi)
测(Ce)量(Liang)HO
Picarro PI2114 可(Ke)测(Ce)量(Liang)低(Di)至(Zhi) 3 ppb 的(De)过(Guo)氧(Yang)化(Hua)氢(Qing) ((?)HO),(?)以(Yi)避(Bi)免(Mian)药(Yao)物(Wu)发(Fa)生(Sheng)氧(Yang)化(Hua)并(Bing)确(Que)保(Bao)药(Yao)物(Wu)稳(Wen)定(Ding)性(Xing)。(?)主(Zhu)要(Yao)的(De)制(Zhi)药(Yao)、(?)合(He)同(Tong)加(Jia)工(Gong)外(Wai)包(Bao) ((?)CMO)(?) 及(Ji)隔(Ge)离(Li)器(Qi)公(Gong)司(Si)都(Du)采(Cai)用(Yong) Picarro 过(Guo)氧(Yang)化(Hua)氢(Qing)分(Fen)析(Xi)仪(Yi),(?)来(Lai)实(Shi)现(Xian)强(Qiang)效(Xiao)原(Yuan)料(Liao)药(Yao) ((?)API)(?) 和(He)生(Sheng)物(Wu)制(Zhi)药(Yao)生(Sheng)产(Chan)以(Yi)及(Ji)无(Wu)菌(Jun)灌(Guan)装(Zhuang)与(Yu)加(Jia)工(Gong)。(?)PI2114 分(Fen)析(Xi)仪(Yi)运(Yun)行(Xing)快(Kuai)速(Su)且(Qie)使(Shi)用(Yong)简(Jian)便(Bian),(?)无(Wu)需(Xu)使(Shi)用(Yong)化(Hua)学(Xue)品(Pin)或(Huo)耗(Hao)材(Cai)。(?)同(Tong)时(Shi),(?)只(Zhi)需(Xu)实(Shi)施(Shi)少(Shao)量(Liang)校(Xiao)准(Zhun)与(Yu)维(Wei)护(Hu),(?)即(Ji)可(Ke)最(Zui)大(Da)限(Xian)度(Du)地(Di)降(Jiang)低(Di)运(Yun)行(Xing)成(Cheng)本(Ben)。(?)
*连(Lian)续(Xu)实(Shi)时(Shi)监(Jian)测(Ce) HO
*检(Jian)测(Ce)下(Xia)限(Xian):(?)<3 ppb((?)5 分(Fen)钟(Zhong)平(Ping)均(Jun)值(Zhi))(?)
*精(Jing)度(Du):(?)<0.5 ppb((?)1σ(?),(?)5 分(Fen)钟(Zhong)平(Ping)均(Jun)值(Zhi))(?)
*上(Shang)升(Sheng)时(Shi)间(Jian) (10 90%) 和(He)下(Xia)降(Jiang)时(Shi)间(Jian) (90 10%) 为(Wei) 2 分(Fen)钟(Zhong)以(Yi)内(Nei)
5分(Fen)钟(Zhong)的(De)精(Jing)密(Mi)度(Du)小(Xiao)于(Yu)0.5 ppb,(?)上(Shang)升(Sheng)时(Shi)间(Jian)((?)10-90%)(?)和(He)下(Xia)降(Jiang)时(Shi)间(Jian)((?)90-10%)(?)小(Xiao)于(Yu)2分(Fen)钟(Zhong),(?)检(Jian)测(Ce)下(Xia)限(Xian)低(Di)于(Yu)3ppb((?)5分(Fen)钟(Zhong)平(Ping)均(Jun))(?)。(?)Picarro PI2114 过(Guo)氧(Yang)化(Hua)氢(Qing)浓(Nong)度(Du)分(Fen)析(Xi)仪(Yi)经(Jing)过(Guo)优(You)化(Hua),(?)适(Shi)用(Yong)于(Yu)GMP应(Ying)用(Yong),(?)软(Ruan)件(Jian)符(Fu)合(He)电(Dian)子(Zi)记(Ji)录(Lu)法(Fa)规(Gui)。(?)PI2114内(Nei)置(Zhi)软(Ruan)件(Jian)符(Fu)合(He)21 CFR part 11的(De)要(Yao)求(Qiu),(?)软(Ruan)件(Jian)对(Dui)电(Dian)子(Zi)记(Ji)录(Lu)、(?)时(Shi)间(Jian)和(He)审(Shen)计(Ji)跟(Gen)踪(Zong)设(She)立(Li)了(Liao)严(Yan)格(Ge)的(De)规(Gui)定(Ding)。(?)PI2114 软(Ruan)件(Jian)系(Xi)统(Tong)结(Jie)合(He)详(Xiang)细(Xi)的(De)验(Yan)证(Zheng)报(Bao)告(Gao)、(?)软(Ruan)件(Jian)和(He)系(Xi)统(Tong)文(Wen)件(Jian),(?)提(Ti)供(Gong)了(Liao)一(Yi)个(Ge)全(Quan)面(Mian)、(?)严(Yan)格(Ge)控(Kong)制(Zhi)的(De)数(Shu)据(Ju)管(Guan)理(Li)功(Gong)能(Neng),(?)符(Fu)合(He)制(Zhi)药(Yao)和(He)商(Shang)业(Ye)制(Zhi)造(Zao)要(Yao)求(Qiu)。(?)Picarro提(Ti)供(Gong)安(An)装(Zhuang)和(He)操(Cao)作(Zuo)认(Ren)证(Zheng)文(Wen)件(Jian)((?)IQ和(He)OQ)(?),(?)并(Bing)具(Ju)有(You)使(Shi)用(Yong)市(Shi)售(Shou)的(De)代(Dai)理(Li)气(Qi)体(Ti)进(Jin)行(Xing)快(Kuai)速(Su)、(?)简(Jian)单(Dan)验(Yan)证(Zheng)的(De)特(Te)点(Dian)。(?)