USP<1207>tau hloov txoj kev lag luam niaj hnub mus rau qhov kev txiav txim siab, lub cev CCIT txoj hauv kev tshaj qhov yuav luag zas xim - lossis microbial - kev kuaj nkag, tab sis kev siv qhov kev txiav txim siab raws li kev txiav txim siab yuav tsum muaj ntau tshaj li kev yuav khoom siv - nws yuav tsum muaj txoj hauv kev txhim kho kom haum rau txhua lub ntim khoom tshwj xeeb - kaw qhov system, txhais tau tias muaj kev cuam tshuam ntau tshaj plaws rau cov khoom lag luam correlated (M).
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 Kev Cai
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
USP<1207>tau hloov txoj kev lag luam niaj hnub mus rau qhov kev txiav txim siab, lub cev CCIT txoj hauv kev tshaj qhov yuav luag zas xim - lossis microbial - kev kuaj nkag, tab sis kev siv qhov kev txiav txim siab raws li kev txiav txim siab yuav tsum muaj ntau tshaj li kev yuav khoom siv - nws yuav tsum muaj txoj hauv kev txhim kho kom haum rau txhua lub ntim khoom tshwj xeeb - kaw qhov system, txhais tau tias muaj kev cuam tshuam ntau tshaj plaws rau cov khoom lag luam correlated (M).
Peb cov kev daws teeb meem
Peb qhov kev txiav txim siab CCIT qhov chaw nyob rauVacuum decay thiab Pressure decay method ob txoj hauv kev ntsuas qhov ntau, nrog rau txoj kev txhim kho kev txhawb nqa los tsim kom muaj qhov siab tshaj plaws tso cai txwv rau koj lub thawv tshwj xeeb - kaw qhov system, ib qho USP<1207.1>kev taw qhia. Lub platform yog tsim raume -batch R&D formulation tshuaj ntsuam xyuas, pilot sim sim thiab siab - ntim niaj hnub tsim tawm kev sim, thiab cov ntaub ntawv pov thawj cov ntaub ntawv raug muab los txhawb<1207.2>kev tsim nyog. Raws li cov chaw tsim khoom peb muabCov txheej txheem kev lees paub raws cai, tag nrho GMP- ua raws IQ / OQ / PQ cov ntaub ntawv pov thawj, ntawm -site CSV computerized system validation service, dawb firmware hloov khoom dua tshiab rau USP standard iteration, tej thaj chaw deb technical troubleshooting thiab ntev - calibration ntawv cog lus txhua xyoo.
Peb Cov Khoom
Ntim Leak Tester MFT-900
Ntim Leak Tester MFT-600
Ntim Leak Tester MFT-1000
Peb Cov Kev Pabcuam
USP<1207>Ua raws CCIT Test Method Development & Analytical Validation Services
1. Kev tshawb fawb thiab kev txiav txim siab ntawm Kev Tso Cai Tshaj Tawm (MAL / MALL) rau pob xau
2. Kev sim txoj kev txhim kho, parameter optimization thiab analytical method validation raws li ICH Q2 cov lus qhia
3. System Suitability Testing (SST), calibration ntawm zoo tswj drilled qauv, thiab xa tag nrho cov ntaub ntawv validation
4. Cov ntaub ntawv rectification thiab txhawb kev soj ntsuam los ntawm FDA, EMA thiab NMPA
FAQ
Q1: Qhov txawv ntawm USP yog dab tsi<1207>, <1207.1>, thiab<1207.2>?
A1: <1207>qhia CCIT cov ntsiab lus thiab cov txheej txheem,<1207.1>npog cov txheej txheem rau kev xaiv ib txoj kev txiav txim siab, thiab<1207.2>npog cov txheej txheem validation thiab kev tsim nyog mus kom ze.
Q2: Dab tsi yog qhov siab tshaj plaws tso cai tso cai txwv (MALL) thiab leej twg teev nws?
A2: MALL yog qhov xau loj tshaj plaws ntawm lub thawv - kaw qhov system tuaj yeem muaj thaum tseem tiv thaiv tsis muaj menyuam thiab cov khoom zoo; nws feem ntau yog tsim los ntawm cov chaw tsim khoom los ntawm kev soj ntsuam kev pheej hmoo thiab kev tshawb fawb txog kev sib raug zoo tshwj xeeb rau lawv cov khoom thiab ntim khoom.
Q3: Lub tshuab nqus tsev puas haum rau txhua hom ntim ntim?
A3: Lub tshuab nqus tsev vacuum ua haujlwm zoo rau ntau lub thawv ntim tab sis yuav xav tau kev hloov kho lossis lwm txoj hauv kev rau qee qhov hloov pauv lossis nyuaj geometries - txoj kev xaiv yuav tsum ua raws<1207.1>yam.
Q4: Yuav ua li cas txiav txim siab CCIT txhawb kev tso tawm sai dua?
A4: Vim tias nws tsim qhov kev ntsuas tam sim, lub hom phiaj ntawm lub cev ntau dua li qhov xav tau kev tsim tawm (raws li nrog kev kuaj microbial ingress), kev txiav txim siab CCIT tuaj yeem txo lub sijhawm kuaj hauv lub voj voog tawm.