Kev soj ntsuam ib puag ncig thiab kev txheeb xyuas kev ncaj ncees rau cov chav huv huv thiab cais tawm, txhawb nqa ISO 14644 kev faib tawm thiab kev tswj kev sib kis tsis tu ncua. Cov chav huv thiab cais tawm tsuas yog muaj kev ntseeg siab raws li lawv qhov kev saib xyuas tsis tu ncua. Kev suav cov khoom, qhov sib txawv siab, thiab hnab looj tes lossis qhov thaiv kev ncaj ncees tuaj yeem maj mam txav ntawm cov txheej txheem tsim nyog, thiab ib qho kev ua txhaum cai tsis raug cai - ib lub hnab looj tes torn, tsis ua tiav HEPA foob - tuaj yeem cuam tshuam kev ua haujlwm aseptic tag nrho. Cov neeg tsim khoom xav tau cov cuab yeej siv uas txhawb nqa ob qhov kev ntsuas kev faib tawm thiab hnub - mus rau - hnub tswj kev tiv thaiv kab mob.
01
Siab Zoo
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
02
Khoom siv Advanced
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
03
Pab neeg tshaj lij
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
04
Kev Pabcuam Cov Neeg Siv Khoom
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
Txoj Cai Tswjfwm
TS EN ISO 14644-1 thiab -2 txhais cov chav huv huv thiab kev saib xyuas tsis tu ncua raws li cov kev txwv particle concentration. EU GMP Annex 1 (2022) nthuav dav kev cia siab nyob ib puag ncig kev sib cais thiab RABS teeb meem kev ncaj ncees raws li ib feem ntawm cov ntaub ntawv pov thawj kev tiv thaiv kev tiv thaiv, suav nrog cov hnab looj tes niaj hnub ntsuas kev ncaj ncees. TS EN ISO 14644-3 Cov txheej txheem xeem siv rau kev faib tawm thiab kev tsim nyog.
Peb cov kev daws teeb meem
Peb chav huv huv thiab cais ntsuas ntsuas npogParticle txee, sib txawv siab transmitters, hnab looj tes kev ntseeg siab testers, lim kev ncaj ncees testers, TOC analyzers thiab ntim kaw kev ntseeg siab (CCIT) testers, txhawb ob qho ISO 14644 kev ntsuam xyuas kev faib tawm thiab kev tswj xyuas kev sib kis tsis tu ncua hauv kev cais tawm thiab RABS enclosures. Cov cuab yeej yog tsim los rauob qho tib si handheld portable niaj hnub soj ntsuam xyuas thiab phab ntsa-mounted tsau hauv internet nruam xyuas, thiab koom ua ke seamlessly nrog cov chaw saib xyuas cov txheej txheem los tswj cov ntaub ntawv sib txawv, cov ntawv ceeb toom thiab cov kev tshawb xyuas. Raws li cov chaw tsim khoom peb muabtag nrho hauv -lub tsev R&D & kev tsim muaj peev xwm, 21 CFR Part 11 ua raws cov kev tshawb xyuas digital traceability, kho kho vajtse / software hloov kho rau cov txheej txheem tshuaj aseptic, ntev - lub sij hawm spare qhov chaw muab khoom thiab thoob ntiaj teb ntawm - qhov chaw validation & tom qab - kev muag khoom kev pab cuam, nrog superior nqi kev ua tau zoo piv nrog cov ntsiab lus tseem ceeb.
Case Study Summary
Aseptic injectable filling rhiav xav tau los ntxiv cov hnab looj tes niaj hnub kuaj kev ncaj ncees rau nws txoj haujlwm cais tawm kev tsim nyog tom qab kev tshuaj xyuas kev tswj xyuas kev sib kis sab hauv.Kev tshawb nrhiav tsis tu ncua tshem tawm cov kev pheej hmoo zais zais ntawm microbial ingress los ntawm cov hnab looj tes puas; tag nrho cov ntaub ntawv pov thawj kev ntseeg siab ntawm hnab looj tes tau khaws cia hauv tshuab hluav taws xob nrog cov kev tshawb xyuas ua tiav raws li 21 CFR Part 11. Kev cais tawm ib puag ncig kev tsim nyog tau nyob ruaj khov ntev -lub sij hawm, kev sib kis sib txawv cuam tshuam txog cov hnab looj tes tsis xws luag raug tshem tawm tag nrho, thiab lub xaib tau ua tiav tom qab EU GMP recertification audit du du.
Khoom Center
Wireless hnab looj tes Integrity Tester WGT-1200
Ntau -Point
Wireless hnab looj tes Integrity Tester WGT-2000
Hnab looj tes kev ntseeg siab Tester GT-2.0 (Online thiab Offline)
Wireless hnab looj tes Integrity Tester WGT-1000
FAQ
Q1: Ntev npaum li cas cov hnab looj tes yuav tsum tau kuaj xyuas kev ncaj ncees?
A1: Ntau zaus yuav tsum tau txhais nyob rau hauv ib qhov chaw txoj kev tswj kev kis kab mob thiab kev tsim nyog tau txais kev pab cuam; EU GMP Annex 1 cia siab tias yuav niaj hnub kuaj cov hnab looj tes yog qhov ua txhaum cai tseem ceeb hauv kev sib cais.
Q2: Dab tsi yog qhov txawv ntawm kev faib chav huv thiab kev saib xyuas tsis tu ncua?
A2: Classification per ISO 14644-1 is a formal, periodic qualification of particle limits for a defined room state, while ongoing monitoring tracks real-time or routine trends between classification events to detect drift or excursions early.
Q3: Ib lub txee puas tuaj yeem ua rau ob qho tib si huv huv thiab cais cais cov kev xav tau?
A3: Nyob ntawm cov qauv ntim, kev teeb tsa chaw nres nkoj, thiab cov kev xav tau ntawm kev sib koom ua ke software, ib lub platform feem ntau tuaj yeem ua haujlwm rau ob qho tib si, txawm tias qee zaum cov neeg sib cais yuav xav tau me dua - hneev taw lossis chaw taws teeb - sojntsuam kev teeb tsa.
Q4: Dab tsi ua rau lub hnab looj ntsej muag tsis ua haujlwm hauv cov khoom sib cais?
A4: Feem ntau ua rau muaj xws li cov neeg kho tshuab hnav los ntawm kev rov ua dua tshiab, tshuaj lom neeg degradation los ntawm sporicidal agents, thiab puncture los ntawm cov cuab yeej ntse lossis cov khoom siv hauv cov khoom sib cais.