Kamore e hloekileng ke eng?
Likamore tse hloekileng, tse tsejoang hape e le likamore tse se nang lerōle, hangata li sebelisoa e le karolo ea tlhahiso ea indasteri ea litsebi kapa lipatlisiso tsa mahlale, ho kenyeletsoa le ho etsoa ha meriana, lijo, li-CRT, li-LCD, li-OLED le lipontšo tsa microLED.Likamore tse hloekileng li etselitsoe ho boloka maemo a tlase haholo a likaroloana, joalo ka lerōle, likokoana-hloko tse tsamaisoang ke moea, kapa li-particulate tse nang le mouoane.
E le ho nepahala, kamore e hloekileng e na le boemo bo laoloang ba tšilafalo, bo hlalositsoeng ke palo ea likaroloana ka li-cubic meter / maoto a li-cubic ka boholo bo boletsoeng.Kamore e hloekileng e ka boela ea bolela sebaka leha e le sefe sa bolulo moo tšilafalo ea likaroloana e fokotsoang le likarolo tse ling tsa tikoloho tse kang mocheso, mongobo le khatello li laoloang.
Kamore e hloekileng ea GMP ke eng?
Ka kutloisiso ea meriana, kamore e hloekileng e bolela kamore e lumellanang le lintlha tsa GMP tse hlalositsoeng ho GMP sterility specifications (ke hore, Annex 1 ea EU le PIC/S GMP Guidelines, hammoho le litekanyetso le litataiso tse ling tse hlokoang ke ba boholong sebakeng sa bophelo bo botle. ).Ke motsoako oa boenjiniere, tlhahiso, phetho, le taolo ea ts'ebetso (maano a taolo) a hlokahalang ho fetolela kamore e tloaelehileng hore e be phaposi e hloekileng.
Ho ea ka litekanyetso tse amehang tsa mekhatlo ea FDA, ba thehile melao e thata le e nepahetseng bakeng sa baetsi ba meriana indastering ea meriana.Mekhoa e Metle ea Tlhahiso (GMP) bakeng sa tlhahiso ea lihlahisoa tsa meriana e hloekisitsoeng e etselitsoe ho netefatsa hore lithethefatsi li bolokehile ebile li na le metsoako le bongata ba tsona.Litekanyetso tsena li ikemiselitse ho fokotsa kotsi ea tšoaetso ea likokoana-hloko, li-particulate le pyrogen.Taolo ena, e tsejoang hape e le mekhoa e metle ea tlhahiso ea hajoale (cGMP), e akaretsa lits'ebetso tsa tlhahiso, taolo ea boleng, ho paka, basebetsi le lisebelisoa tsa GMP.
Ha ho etsoa litlhare tse sa hloekang le lisebelisoa tsa bongaka, ka kakaretso ha ho hlokahale likamore tse hloekileng tsa boemo bo holimo, athe bakeng sa tlhahiso ea lithethefatsi tse hloekisitsoeng, tse kang limolek'hule le litlhare tsa maiketsetso, ho hlokahala hore ho be le likamore tse hloekileng tsa boemo bo holimo. - Likamore tse hloekileng tsa GMP.Re ka hlalosa tikoloho bakeng sa tlhahiso ea lithethefatsi tse hloekisitsoeng le lihlahisoa tsa likokoana-hloko ho latela boemo ba moea o hloekileng oa GMP le lihlopha.
Ho latela litlhoko tse amehang tsa melaoana ea GMP, tlhahiso ea lithethefatsi tse hloekisitsoeng kapa lihlahisoa tsa baeloji e arotsoe haholo ka mekhahlelo e mene: A, B, C, le D.
Mekhatlo ea hajoale ea taolo e kenyelletsa: ISO, USP 800, le US Federal Standard 209E (eo pele e neng e ntse e sebelisoa).Molao oa Boleng le Polokeho ea Lithethefatsi (DQSA) o entsoe ka Pulungoana 2013 ho sebetsana le mafu a amanang le lithethefatsi le liketsahalo tse mpe tse tebileng.Molao oa Federal Food, Drug, and Cosmetic Act (FD&C Act) o theha litataiso le maano a khethehileng a foromo ea motho.503A e hlahisoa ke mmuso kapa mokhatlo o lumelletsoeng oa mmuso o tlas'a bookameli ba basebetsi ba lumelletsoeng (bo-rakhemisi/lingaka) 503B e amana le lits'ebeletso tsa kantle ho naha mme e hloka taolo e tobileng ke bo-rakhemisi ba nang le lengolo la tumello, eseng likhemisi tse nang le lengolo la tumello.Feme e fuoa lengolo la tumello ke Tsamaiso ea Lijo le Lithethefatsi (FDA).
DERSION Kamore e Hloekileng ea Modular
1. HO KENYA KA POTLAKO LE BONOLO
Monyetla o totobetseng oa likamore tse hloekileng tsa modular ke hore li bonolo ebile li potlakile ho kenya.Ha ho hlokahale hore li hahuoe ho tloha qalong 'me li ke ke tsa senya ts'ebetso ea hau ka libeke kapa likhoeli tsa nako ea kaho.Li entsoe ka liphanele tse entsoeng esale pele le liforeimi, kahoo li ka hlophisoa ka mor'a matsatsi kapa libeke.Ka ho khetha kamore e hloekileng ea DERSION, mokhatlo oa hau o ka qoba tieho mme oa qala ho sebelisa phaposi ea hau ea bohloeki hang hang.
Ho feta moo, moralo oa patent oa DERSION o etsa hore ho be bonolo ho kopanya kapa ho qhaqha likamore tsa rona tse hloekileng tsa modular le ho boloka chelete e ngata ho tsona.Sena se bolela hore bareki ba rona ba na le monyetla oa ho eketsa, kapa ho fokotsa, kapa ho fokotsa phaposi ea bona e hloekileng ha litlhoko tsa mokhatlo oa bona li fetoha.Hobane likamore tsa rona tse hloekileng tsa modular ha se meaho ea ka mehla, li bitsa chelete e tlase ho li reka le ka litšenyehelo tse tlase tsa tlhokomelo.
2. KETSAHALO EA TŠEBELETSO
Likamore tsa ho hloekisa ka mokhoa o tloaelehileng li sebelisa li-filters tsa HEPA le ULPA ho tlosa ntho e itseng moeeng le ho boloka tšilafalo bonyane bo hlokahalang.DERSION e fana ka mefuta e fapaneng ea liphaposi tse hloekisang le lisebelisoa tse hloekisang tse ka thusang mokhatlo oa hau ho latela litekanyetso tsa ISO, FDA, kapa EU.Ka bobeli liphaposi tsa rona tsa bohloeki tsa software le rigidwall li kopana le litekanyetso tsa bohloeki ba moea tsa ISO 8 ho isa ho ISO 3 kapa Kereiti ea A ho ea ho Sehlopha sa D.Likamore tsa rona tsa ho hloekisa li-rigidwall ke tharollo ea theko e tlase bakeng sa ho fihlela litlhoko tsa USP797.
Melemo ea likamore tse hloekileng tsa modular ho feta likamore tse hloekileng tsa setso li ngata.Theko ea bona, ho kenya le ho e hlokomela habonolo, le ts'ebetso ha nako e ntse e ea li li etsa khetho e ntle bakeng sa lik'hamphani kapa mekhatlo e hlokang tikoloho ea kamore e hloekileng ho sebetsa hang-hang.Ho DERSION re lumela boleng ba lihlahisoa tsa rona tsa phaposi ea bohloeki le ho tenyetseha ha tsona tseo li fanang ka tsona ho bareki ba rona.Bakeng sa lintlha tse ling mabapi le hore na lihlahisoa tsena li ka thusa mokhatlo oa hau joang ho fihlela litlhoko tsa ona, sheba maqephe a rona a li-softwall le rigidwall modular clean room.
