SHANGHAI, Suav teb- ALWELL, tus thawj tshaj plaws thoob ntiaj teb pioneer hauv cov tshuab kws tshuaj tshwj xeeb thiab siab -precision automated filling systems, txaus siab los tshaj tawm txoj kev xa mus ua tiav ntawm lwm qhov turnkeyUa ntej-Filled Syringe (PFS) filling thiab stoppering ntau lawm kabmus rau ib lub chaw tsim tshuaj biopharmaceutical tseem ceeb hauv Tebchaws Meskas.
Qhov kev xa tawm tseem ceeb no qhia txog ALWELL txoj kev loj hlob hneev taw nyob rau hauv kev tswj hwm sab hnub poob kev lag luam, ua kom pom peb lub peev xwm muaj peev xwm xa cov kev cai engineering automation uas ua tiav tag nrho ob qho tib si nruj FDA cov lus qhia thiab cov qauv cGMP thoob ntiaj teb.
Engineered rau siab -Viscosity thiab Sterile Precision
Kev xa cov kua filling configuration yog kev cai -engineered los lis complex kua filling thiab advanced aseptic stoppering sequences nrog heev raug. Ua tau siv lub xeev- ntawm--art servo-tsav architectures thiab kho mob- cov ntaub ntawv qib, lub kaw lus sib txuas ua ke ntau cov txheej txheem thev naus laus zis tsim tshwj xeeb rau kev kho mob kom zoo nkauj thiab biopharmaceutical kua:
Advanced Nqus Filling & Stoppering Tech: Mitigates npuas tsim nyob rau hauv siab -viscosity gels thiab micro-dose saline daws, kom ntseeg tau tias flawless npuas - dawb sealing.
100%.
Yooj Yim Npaj-rau-Siv (RTU) Hom: Seamlessly kho kom ua tiav ua ntej -sterilized nested syringes, cartridges, thiab vials ntawm ib qho lus, sib koom ua ke 3-hauv-1 combo base unit.
"Tebchaws Asmeskas cov kws kho mob xav tau qib siab tshaj plaws ntawm cov qauv kev ua kom tsis muaj menyuam thiab kev lees paub tseeb. Qhov kev xa khoom no ua pov thawj tias ALWELL pawg neeg ua haujlwm tuaj yeem ua tiav cov haujlwm ua haujlwm nyuaj uas ua tiav nrog rau North American lub Hoobkas kev cia siab thiab kev tswj hwm nruj."- Tus Thawj Coj ntawm International Engineering, ALWELL
Uncompromised Quality nyob rau hauv txhua pob nthuav dav
Thaum xa tawm mus rau cov cheeb tsam thoob ntiaj teb zoo li North America, kev nyab xeeb kev thauj mus los tsuas yog qhov tseem ceeb raws li cov khoom siv software ua raws. Pab pawg ALWELL logistical ua haujlwm tau siv cov txheej txheem ntau- txheej txheej txheej txheej txheej txheej txheej, ua tiav lub tshuab nqus tsev- kaw desiccant encapsulation, thiab ntxiv hnyav-lub luag haujlwm ISPM-15 ntawv pov thawj los tiv thaiv- kev vibration cav ntoo. Txhua yam khoom siv sab hauv tau raug tso tseg kom tiv taus dej hiav txwv- hla inertia, kom ntseeg tau tias cov tshuab tuaj txog ntawm cov neeg siv khoom nyob rau hauv ib qho kev hloov pauv, lub Hoobkas-tshiab.
Accelerated FDA Validation & Comprehensive Lifecycle Support
Txhawm rau pab txhawb kev xa tawm sai sai thaum tuaj txog, cov kab ntau lawm tau txais kev txhawb nqa los ntawm ALWELL qhov kev pabcuam thoob ntiaj teb kev siv tau zoo. Cov pob ntawv suav nrog ua tiav, traceably auditable DQ, IQ, OQ, thiab PQ cov ntaub ntawv, tso cai rau tus neeg siv khoom QA / QC pab pawg txhawm rau txhim kho cov kev tsim nyog sab hauv. Tsis tas li ntawd, ALWELL cov kws tshaj lij engineering yuav saib xyuas qhov yuav los tom ntej ntawm -Site Acceptance Testing (SAT) thiab muab kev cob qhia rau cov neeg ua haujlwm kom paub tseeb tias cov cuab yeej ua haujlwm tau zoo.
Los ntawm kev ua haujlwm txuas ntxiv thiab kev mob siab rau kev tsim kho aseptic zoo tshaj plaws, ALWELL tseem yog tus neeg siv khoom siv hluav taws xob tso siab rau kev ua lag luam biopharmaceutical thiab kev kho mob zoo nkauj thoob ntiaj teb.
TXOJ KEVyog ib qho kev lag luam- ua cov chaw tsim khoom ntawm cov kws tshuaj tshuab thiab cov tshuab ua kom tsis muaj menyuam puv tshuab. Specializing nyob rau hauv advancedkua filling kuarau RTU syringes, cartridges, thiab vials, ALWELL txhawb lub ntiaj teb lub neej- kev lag luam kev tshawb fawb los ntsuas kev tsim khoom kom nyab xeeb thiab ua tau zoo. Rau kev nug lossis kev thov 3D layout simulation thov, thov mus saib peb lub vev xaib official lossis tiv tauj peb lub rooj sib tham engineering thoob ntiaj teb.