Kodi chipinda choyera ndi chiyani?
Zipinda zoyera, zomwe zimadziwikanso kuti zipinda zopanda fumbi, zimagwiritsidwa ntchito ngati gawo la akatswiri opanga mafakitale kapena kafukufuku wasayansi, kuphatikiza kupanga mankhwala, chakudya, ma CRT, ma LCD, OLED, ndi mawonedwe a microLED.Zipinda zoyera zimapangidwira kuti zizikhala ndi tinthu tating'ono kwambiri, monga fumbi, zamoyo zoyendetsedwa ndi mpweya, kapena tinthu tating'onoting'ono ta vaporized.
Kunena zowona, chipinda choyera chimakhala ndi mlingo woipitsidwa woyendetsedwa, womwe umatchulidwa ndi chiwerengero cha particles pa cubic mita / pa mapazi a cubic pa kukula kwake kwa tinthu.Chipinda chaukhondo chingatanthauzenso malo aliwonse okhalamo pomwe tinthu tating'onoting'ono towonongeka timachepa komanso magawo ena achilengedwe monga kutentha, chinyezi, komanso kupanikizika kumayendetsedwa.
Kodi chipinda choyera cha GMP ndi chiyani?
M'lingaliro lazamankhwala, chipinda choyera chimayimira chipinda chomwe chimakwaniritsa zofunikira za GMP zomwe zafotokozedwa muzolemba za GMP (mwachitsanzo Annex 1 ya EU ndi PIC/S GMP Guidelines, komanso miyezo ndi malangizo ena ofunikira ndi akuluakulu azaumoyo amderalo. ).Ndi kuphatikiza kwa uinjiniya, kupanga, kumaliza, ndi kuwongolera magwiridwe antchito (njira zowongolera) zomwe zimafunikira kuti chipinda chokhazikika kukhala chipinda choyera.
Malinga ndi miyezo yoyenera ya mabungwe a FDA, akhazikitsa malamulo okhwima komanso olondola kwa opanga mankhwala pamakampani opanga mankhwala.Njira Zabwino Zopangira Zinthu (GMP) zopangira mankhwala osabala zidapangidwa kuti zitsimikizire kuti mankhwalawo ndi otetezeka komanso amakhala ndi zosakaniza zomwe amati ndi kuchuluka kwake.Miyezo iyi ikufuna kuchepetsa chiwopsezo cha kuipitsidwa kwa ma microbial, particulate, ndi pyrogen.Lamuloli, lomwe limadziwikanso kuti kachitidwe kabwino kamakono (cGMP), limakhudza njira zopangira, kuwongolera bwino, kuyika, ogwira ntchito, ndi malo a GMP.
Popanga mankhwala osabala ndi zida zachipatala, nthawi zambiri sizifunikira zipinda zaukhondo zapamwamba, pomwe popanga mankhwala osabala, monga mankhwala opangira ma cell ndi mankhwala opangira, pafunika kukhala ndi zipinda zaukhondo zapamwamba. - Zipinda zoyera za GMP.Titha kufotokozera chilengedwe chopangira mankhwala osabala ndi zinthu zachilengedwe kutengera mulingo wa mpweya wabwino wa GMP ndi gulu.
Malinga ndi zofunikira za malamulo a GMP, kupanga mankhwala osabala kapena zinthu zachilengedwe zimagawidwa m'magulu anayi: A, B, C, ndi D.
Mabungwe olamulira omwe alipo pano akuphatikiza: ISO, USP 800, ndi US Federal Standard 209E (poyamba, ikugwirabe ntchito).The Drug Quality and Safety Act (DQSA) idakhazikitsidwa mu Novembala 2013 kuthana ndi imfa zokhudzana ndi mankhwala osokoneza bongo komanso zochitika zoyipa kwambiri.Federal Food, Drug, and Cosmetic Act (FD&C Act) imakhazikitsa zitsogozo ndi mfundo zamtundu wamunthu.503A imapangidwa ndi boma kapena bungwe lovomerezeka ndi boma moyang'aniridwa ndi ogwira ntchito ovomerezeka (madokotala/madokotala) 503B imagwirizana ndi malo omwe ali ndi ntchito zakunja ndipo imafuna kuyang'aniridwa mwachindunji ndi ogulitsa mankhwala omwe ali ndi zilolezo, osati ma pharmacies ovomerezeka.Fakitale ili ndi chilolezo kudzera ku Food and Drug Administration (FDA).
DERSION Modular Clean Room
1. KUWEKA KWAMBIRI NDIPONSO KWAMBIRI
Ubwino wodziwikiratu wa zipinda zoyera za modular ndikuti ndizosavuta komanso zosavuta kuziyika.Siziyenera kumangidwa kuyambira pachiyambi ndipo sizidzasokoneza ntchito yanu ndi masabata kapena miyezi yomanga.Amapangidwa kuchokera ku mapanelo opangidwa kale ndi mafelemu, kotero amatha kukhazikitsidwa mkati mwa masiku kapena masabata.Posankha chipinda choyera cha DERSION, gulu lanu litha kupewa kuchedwa ndikuyamba kugwiritsa ntchito chipinda chanu choyeretsa nthawi yomweyo.
Kuonjezera apo, mapangidwe a patent a DERSION amapangitsa kuti zikhale zosavuta kusonkhanitsa kapena kusokoneza zipinda zathu zoyera komanso zotsika mtengo kuti ziwonjezere.Izi zikutanthauza kuti makasitomala athu ali ndi mwayi wowonjezera, kapena kuchotsa, zipinda zawo zoyera zomwe zimakhazikitsidwa pomwe zosowa za bungwe lawo zikusintha.Chifukwa zipinda zathu zaukhondo sizikhala zokhazikika, zimawononga ndalama zogulira komanso zotsika mtengo.
2. KUCHITA KWAKHALIDWE
Zipinda zotsuka mokhazikika zimagwiritsa ntchito zosefera za HEPA ndi ULPA kuti zichotse zinthu mlengalenga ndikuchepetsa kuipitsidwa.DERSION imapereka zipinda zoyeretsera zosiyanasiyana ndi zida zoyeretsera zomwe zingathandize bungwe lanu kutsatira miyezo ya ISO, FDA, kapena EU.Zipinda zathu zonse zoyeretsera pakompyuta ndi zolimba zimakumana ndi miyezo ya ukhondo wa mpweya wa ISO 8 mpaka ISO 3 kapena Giredi A mpaka Grade D.Zipinda zathu zotsuka zolimba ndi njira yotsika mtengo yokwaniritsa zofunikira za USP797.
Ubwino wa zipinda zoyera kuposa zipinda zachikhalidwe ndizochuluka.Kukwanitsa kwawo, kukhazikitsa kosavuta ndi kukonza, komanso kugwira ntchito pakapita nthawi kumawapangitsa kukhala chisankho chabwino kwambiri kwamakampani kapena mabungwe omwe amafunikira malo oyeretsa kuti azigwira ntchito nthawi yomweyo.Ku DERSION timakhulupirira mumtundu wazinthu zathu zoyera komanso kusinthasintha komwe amapereka kwa makasitomala athu.Kuti mumve zambiri za momwe zinthuzi zingathandizire gulu lanu kukwaniritsa zosowa zake, onani masamba athu apachipinda choyera cha pulogalamu yaukhondo ndi rigidwall.
