Liyini igumbi elihlanzekile?
Amakamelo ahlanzekile, awaziwa nangokuthi amagumbi angenalo uthuli, avame ukusetshenziswa njengengxenye yokukhiqiza kwezimboni eziqeqeshiwe noma ucwaningo lwesayensi, okuhlanganisa ukukhiqizwa kwemithi, ukudla, ama-CRT, ama-LCD, ama-OLED, nezibonisi ze-microLED.Amakamelo ahlanzekile aklanyelwe ukugcina amazinga aphansi kakhulu ezinhlayiya, njengothuli, izinto eziphilayo ezihamba emoyeni, noma izinhlayiya ezihwamukile.
Ukunemba, igumbi elihlanzekile linezinga lokungcola elilawulwayo, elicaciswa inani lezinhlayiya nge-cubic meter ngayinye / cubic feet ngayinye kusayizi wezinhlayiyana ezithile.Igumbi elihlanzekile lingaphinde libhekisele kunoma iyiphi indawo yokuhlala lapho kuncipha khona ukungcoliswa kwezinhlayiyana kanye neminye imingcele yemvelo efana nezinga lokushisa, umswakama, nokucindezela kulawulwa.
Liyini igumbi elihlanzekile le-GMP?
Ngomqondo wokwenza imithi, igumbi elihlanzekile lisho igumbi elihlangabezana nezicaciso ze-GMP ezichazwe ezincazelweni zokuqina ze-GMP (okungukuthi, i-Annex 1 ye-EU kanye ne-PIC/S GMP Guidelines, kanye namanye amazinga neziqondiso ezidingwa iziphathimandla zezempilo zendawo. ).Kuyinhlanganisela yobunjiniyela, ukukhiqiza, ukuqedwa, nezilawuli zokusebenza (amasu okulawula) adingekayo ukuze kuguqulwe igumbi elivamile libe igumbi elihlanzekile.
Ngokwezindinganiso ezifanele zama-ejensi we-FDA, basungule imithethonqubo eqinile nenembayo yabakhiqizi bemithi embonini yezemithi.Imikhuba Emihle Yokukhiqiza (GMP) yokwenziwa kwemikhiqizo yemithi eyinyumba yenzelwe ukuqinisekisa ukuthi imithi iphephile futhi iqukethe izithako ezifunwayo kanye nenani.Lezi zindinganiso zihlose ukunciphisa ubungozi bokungcoliswa kwe-microbial, particulate, kanye ne-pyrogen.Lo mthethonqubo, owaziwa nangokuthi izinqubo zokukhiqiza ezinhle zamanje (cGMP), uhlanganisa izinqubo zokukhiqiza, ukulawulwa kwekhwalithi, ukupakisha, abasebenzi, kanye nezindawo ze-GMP.
Ekwenziweni kwezidakamizwa ezingezona inyumba nemishini yezokwelapha, ngokuvamile asikho isidingo samakamelo ahlanzekile okusezingeni eliphezulu, kuyilapho ukukhiqizwa kwezidakamizwa eziyinyumba, njengezidakamizwa zamangqamuzana nezidakamizwa zokwenziwa, kunesidingo ngokungenakugwenywa samakamelo ahlanzekile asezingeni eliphezulu. - Amagumbi ahlanzekile e-GMP.Singachaza imvelo yokukhiqizwa kwemithi eyinyumba kanye nemikhiqizo yebhayoloji ngokusekelwe ezingeni lomoya ohlanzekile we-GMP kanye nokuhlukaniswa.
Ngokwezidingo ezifanele zemithetho ye-GMP, ukukhiqizwa kwemithi eyinyumba noma imikhiqizo yebhayoloji ihlukaniswe ikakhulukazi ngamaleveli amane: A, B, C, kanye no-D.
Izindikimba zamanje ezilawulayo zifaka: ISO, USP 800, kanye ne-US Federal Standard 209E (ngaphambilini, esasetshenziswa).Umthetho Wekhwalithi Nokuphepha Kwezidakamizwa (i-DQSA) washaywa ngoNovemba 2013 ukuze kubhekwane nokufa okuhlobene nezidakamizwa kanye nezigameko ezimbi kakhulu.I-Federal Food, Drug, and Cosmetic Act (FD&C Act) isungula imihlahlandlela ethile nezinqubomgomo zefomula yomuntu.I-503A ikhiqizwa isikhungo esigunyaziwe sombuso noma sombuso ngaphansi kokuqondisa kwezisebenzi ezigunyaziwe (osokhemisi/odokotela) 503B ihlobene nezindawo ezinikezwe abantu ngaphandle futhi idinga ukugadwa okuqondile ngosokhemisi abanelayisensi, hhayi amakhemisi anelayisensi.Imboni inelayisensi ngeFood and Drug Administration (FDA).
I-DERSION Igumbi Elihlanzekile Elihlanzekile
1. UKUFAKA OKUSHESHA FUTHI OKULULA
Inzuzo esobala kakhulu yamakamelo ahlanzekile e-modular ukuthi alula futhi ayashesha ukuwafaka.Akudingekile ukuba zakhiwe kusukela ekuqaleni futhi ngeke ziphazamise ukusebenza kwakho ngamaviki noma izinyanga zesikhathi sokwakha.Zenziwe ngamaphaneli enziwe ngaphambili kanye nohlaka, ngakho-ke zingasethwa phakathi kwezinsuku noma amasonto.Ngokukhetha i-DERSION modular clean room, inhlangano yakho ingagwema ukubambezeleka futhi iqale ukusebenzisa igumbi lakho lokuhlanza cishe ngokushesha.
Ngaphezu kwalokho, idizayini yelungelo lobunikazi le-DERSION yenza kube lula ukuhlanganisa noma ukuhlakaza amagumbi ethu ahlanzekile ajwayelekile futhi kungabizi kakhulu ukungeza kuwo.Lokhu kusho ukuthi amakhasimende ethu anekhono lokwengeza, noma ukususa kulo, igumbi lawo elihlanzekile elimiswa njengoba izidingo zenhlangano yawo zishintsha.Ngenxa yokuthi amakamelo ethu ahlanzekile awazona izakhiwo ezihlala njalo, kubiza kancane ukuwathenga futhi anezindleko eziphansi zokulungisa.
2. UKUSEBENZA KWEKHWALITHI
Izindlu zokuhlanza eziyimojuli zisebenzisa amayunithi okuhlunga abalandeli be-HEPA kanye ne-ULPA ukuze kususwe ingcosana emoyeni futhi kugcinwe ukungcola kusezingeni eliphansi elidingekayo.I-DERSION inikezela ngezinhlobonhlobo zamagumbi ahlanzekile nezisetshenziswa zegumbi elihlanzekile ezingasiza inhlangano yakho ithobelane nezindinganiso ze-ISO, FDA, noma ze-EU.Kokubili amagumbi ethu okuhlanza ama-softwall nama-rigidwall ahlangabezana nezilinganiso zokuhlanzeka komoya ze-ISO 8 kuya ku-ISO 3 noma zeBanga A kuye ku-Grade D.Amakamelo ethu okuhlanza ama-rigidwall ayisixazululo esingabizi kakhulu sokuhlangabezana nezidingo ze-USP797.
Izinzuzo zamagumbi ahlanzekile e-modular ngaphezu kwamagumbi ahlanzekile endabuko ziningi.Ukufinyeleleka kwazo, ukufakwa kalula nokunakekelwa kwazo, nokusebenza ngokuhamba kwesikhathi kuzenza zibe yisinqumo esihle kakhulu sezinkampani noma izinhlangano ezidinga indawo ehlanzekile ukuze zisebenze ngaso leso sikhathi.Kwa-DERSION sikholelwa kukhwalithi yemikhiqizo yethu yegumbi elihlanzekile kanye nokuvumelana nezimo ezikunikeza amakhasimende ethu.Ukuze uthole imininingwane eyengeziwe yokuthi le mikhiqizo ingasiza kanjani inhlangano yakho ukuthi ihlangabezane nezidingo zayo, bheka amakhasi ethu e-softwall kanye ne-rigidwall modular clean room.
