Izindawo ezinomthwalo vs. Izindawo eziyincane: Ukuqondwa, Izinqambu, & Izinkimbinkimbi

Izidingo Zokuphatha: Ukuthi I-Sterile ne-Clean Rooms Ziyithini Ngempela

I-Clean Room: Indawo Ekhokhwa Ngokuphepha Ukuncamisa Izilwane (Izindlela Zokuphatha Zase-ISO 14644-1)

I-Clean Room yindawo eyakhokhwa ngokuphepha kakhulu ekhokhwa ukuncamisa izilwane zokuhamba kwezilwane—akayi ukuncamisa kwezilwane zokugqibela. Iyasebenza ngokuphepha kwe-ISO 14644-1, okuyisifundo sokubeka izilwane zokuhamba kwezilwane ngokuphepha kwezilwane eziningi kwezilwane zokuhamba kwezilwane (isibonelo, i-ISO Class 5 iyavumela ≤3,520 izilwane ≥0.5 µm/m³). Izindlela zokuphatha zokuphepha zokuphatha kuzo ziyizinto ezilandelayo:

• Ukukhokha kwe-HEPA , okukhokha izilwane zokuhamba kwezilwane zokuhamba kwezilwane ≥0.3 µm ngokuphepha kwe-99.97%
• Izilinganiso zokuphatha kwezilwane zokuhamba kwezilwane , okwenza umoya uhlale ukudlula ngokuphepha ukuvikela ukudluliswa kwezilwane zokuhamba kwezilwane
• Izinyathelo ezingakhi zokuhamba kwezilwane , kusuka kwezinyathi kanye nezinyathi zokuhamba kwezilwane kuya kumaqondiso nezinyathi zokuhamba kwezilwane

Amakhaya okukhulula ayizimela ukuthi kubhekwe ngokupheleleyo ukuthi kubhekwe izinto ezingaphansi kwemithombo yezinto ezihlukene, kungakho kubalulekile kuzokwenza amaphutha amahle, kuzokwenza amaphutha amahle abantu, nokuzokwenza izinkampani zokuhlela izinto ezihlukene, lapho isibonelo sezinto ezihlukene esingaphansi kwesigaba sokugcina (nanoscale) sikhupha umsebenzi noma ukuthi kufanele kusukwane.

Indawo Ekhululwe: Indawo Ebalulekile Ekuthinteni Amashilini (EU GMP Annex 1, USP <1211>)

Indawo ekhululwe yisikhiwo esibhalwe sokuzokwenza izinkampani zokuhlela izinto ezihlukene—esibhalwe kungakho kuphela ukuthi kunciphise izinto ezihlukene, kodwa ukuthi kunciphise amashilini amanquma ngokusebenzisa izindlela eziphathelene ngezinye, nezibhalwe. Kuyisibonelo se-EU GMP Annex 1 ne-USP <1211>, kufika emthwakathwaka wokukhulula (SAL) we-≤10⁻³ ngokusebenzisa:

• Umfushane wokuphambuka kumgodi wokuphambuka , okunqamuka kahle ngokusebenzisa amafiltara ayo ULPA (ayiqiniseka ngokuphambuka kwe-99.999% kumgodi wokuphambuka we-0.12 µm)
• Ukubalwa kokuphambuka kwezindawo , kufaka isibonelo sesibonelo sokuphambuka, ukubalwa kwezindawo zokuphambuka, nokubalwa kwezindawo zokuphambuka kwezindawo zokuphambuka
• Izindlela zokukhulula eziyisibonelo , njengezikhathi zokuvula kwe-hydrogen peroxide (VHP) nokubamba izindlela zokugcina abantu ngokuphelele

Kungasemthwakathini wokusebenza, izindlu zokuhlanya kumele zibe nezikhathi zokufaka imidiya—izikhathi zokusebenza ngokuphelele ezinamandla okukhanya, okunqamuka ngokusebenzisa imidiya yokuthuthukisa—ukubonisa ukuthi izindlela zokuhlanya ziyisisekelo sokuhlinzekile. Kuma-ISO Class 5 amazindlu okuhlanya, izindlela zokudesign zimele zibone ukuthi kunezikhathi zokushintsha kwamanzi ≥240 ngamuhla ukuze kususwe umsindo wokushintsha ngendlela eyodwa futhi kuzivimise ukuthuthukisa kwe-microbe, okuxhumana ngqo nesigcino sendlela yokuhlanya yezinkampani zokwenza iziliso zokuhlanya.

Isahluko sokuhlanya vs Isahluko sokusebenza: Izinqumbu zokudesign nezindlela zokusebenza eziphathelene ngezinto zokusebenza

Ukuphatha Kwamanzi & Ukufiltera: HEPA vs. ULPA, Izikhathi Zokushintsha Kwamanzi, Nokushintsha Kwesifunda

Izinhlangano ze-HVAC zezindawo eziphakanyiswa ngokuphelele zisebenza kumaqhelabha amathathu okunye kwezindawo eziphakanyiswa ngokuphelele. Umahluko omkhulu uphakathi kwezinye izinhlangano ziyizindlela zokulawula - enye iyaziphatha ngokugcina amaphutha ngaphandle, futhi enye iyaziphatha ngokususa amakhemikali ngokuphelele. Izinhlangano zombili zisebenzisa amafiltara amahle kakhulu, kodwa izindawo eziphakanyiswa ngokuphelele zihamba kude ngokufaka amafiltara we-ULPA ozokubona abantu abaningi kakhulu (99.999%) wezinto ezingaphezulu kwe-0.12 microns. Lokhu kuyisilinganiso esihle kakhulu kunamafiltara we-HEPA angaphansi kwezinye ozokubona abantu abaningi kakhulu (99.97%) kwezinto ezingaphezulu kwe-0.3 microns. Lokhu okungcono kokulawula kwenza ukwenzeka ukususa izinto ezingaphezulu kwezivili nezinkundla zamakhemikali, lokho okudingekile kakhulu uma kufundiswa izindawo eziphakanyiswa ngokuphelele emalabho noma emasithili wezinhlangano zokuphatha izilimi.

Inombolo yezinguqulelo zewaya iyahamba ngokwesilinganiso sezindawo. Umzekelo, izindawo zokuhlanzwa zase-ISO Class 7 zidinga ngaphezu kwezinguqulelo ezinzima zewaya ngasikhathi sokuhlanza ngasikhathi esinye. Izindawo zokuhlanzwa zase-Grade A/B zidinga phakathi kwezinguqulelo ezifana ne-40 ku-60 ngasikhathi sokuhlanza ngasikhathi esinye. Izindawo eziphambili kakhulu, izindawo zokuhlanzwa zase-ISO 5, zidinga ngaphezu kwezinguqulelo ezinzima zewaya ngasikhathi sokuhlanza ngasikhathi esinye (240) ukuze kubuyiselwe imisebenzi yokuhlanzwa yeziflow ezingaphansi kanye nokuphula kancane kwezinhlobo zezinto ezingaphansi zokuhlanzwa. Uma sibhekisela kwezinguqulelo zempilo, kuzoba kubanzi kakhulu. Izindawo zokuhlanzwa zidinga ukuthi kubekho umahluko wempilo oyingaphezu kwe-+15 Pa phakathi kwezindawo, ngakolunye uhlangothi izindawo zokuhlanzwa zezindawo ezingaphansi zihlala kumathuba we-+10 ku-+15 Pa. Lezi zinguqulelo zempilo zinconywa ukuthi zithathe isimo sokuhlanza esingaphansi sokuhlanza ngendlela eyodwa kuphela, okuyisimo esinconywa ukuthi siphuma kwezinto ezingaphansi nezinhlobo zezinto ezingaphansi kusukela kwezindawo ezinconywa ukuthi ziyisisekelo sesimo sokusebenza.

Ukuqinisekisa & Ukujabulisa: Ukubala Amaphakathi vs. Ukuzilungiselela Kwezinhlobo Zemithi & Izinkomba Zemithi

Ukuqinisekisa kuhlanganisa kahle: izindawo eziphakeme zokusebenza zihlanganisa abaninzi abahlulekile ngamaphakathi amathathu nezinye ngokwesikhathi noma ngokwesikhathi esisodwa ngokwesibonelo se-ISO 14644-1, ngakolunye uhlangothi izindawo eziphakeme zokusebenza zihlanganisa esibhalwe ngokuphatha kwemithi yezinhlobo zemithi ngokwesibonelo se-EU GMP Annex 1. Ukujabulisa kwezinhlobo zemithi kusenza isibonelo esisodwa—kepha ezindaweni eziphakeme zokusebenza, kusenza isibonelo sesikhathi sokufika kwemithi, akasenza isibonelo sesiphetho.

Ukuqinisekisa okuphelele kokuphakeme kudinga ubuchwepheshe obugcina imithi:

• Ukuzilungiselela kwezinhlobo zemithi ngamatheleli okukhanya, amatheleli okuxhumana, namasampula wemithi okusebenza ngokwesikhathi
• Izinkomba zemithi , okwenziwa ngasinye isikhathi esingama-6, zisimula ukusebenza okuphakeme kakhulu ngokwesikhathi ngokwesibonelo sebrothi yemithi yokuphakema ukuze kutholwe ukufika kwemithi
• Izifundo zemithi zokuqinisekisa kwe-ATP , esetshenziswa ukubala ngokushesha kwezinye izinsiza zokuhlanza kwisurface

Ngaphandle kwalokho, izindawo zokuhlanya ezingasenziwa ngokuphatha kuzo ngokupheleleyo zihlanganisa umnyango wemiphumela yezinye izinsiza ngomnyaka, noma kunjalo akukho inkinga yokubala ukuthi kungabi nempilo noma ukufaka isimelo sesimo sokusebenza. Le mfundo yombili yokuqinisekisa iyathinta izindawo zokuhlanya ezinamandla ukuthi zifanele kumlinganiso we-SAL wokugcina ≤10⁻³—lobu buphakade ubungakanani kwezinye indawo engasenziwa ngokuphatha kuzo ngokupheleleyo ngalokho okusenziwa ngokupheleleyo ngalokho okusenziwa ngokupheleleyo.

Amasevisi wesayensi: Lapho kufanele usebenzise indawo enamandla ngokuphatha kuzo ngokupheleleyo noma indawo enamandla ngokuphatha kuzo ngokupheleleyo

Ukwenza amadragu ngokuphatha kuzo ngokupheleleyo: Kungani izindawo zokuhlanya zezigaba A/B zidinga ukuthi kubhekwe ngokuphatha kuzo ngokupheleleyo

Kodwa kufundwa ngamadragi okugcina ngokugcina, amavaksini, nemithombo yezinhlobo zokubaluleka, ukugcina kwe-sterility akakwazi ukuthi kubhekwe njengokungafanele ngoba ukuthi kubhekwe ngokungafanele kwe-microbial contamination kuyabika izinkinga ezinkulu zokuphila okungaba yizinkinga zokuphila kakhulu. Amadirekthive asebenzisa i-EU GMP Annex 1 ayasiza amaphuzu okugcina kwe-cleanroom okufanele kuzisikhalo sezinhlobo zokuphatha kwe-manufacturing. Ngokushesha, i-Grade A (okuyi-ISO 5 standards) ne-Grade B (okuyi-ISO 7) kufanele kubhekwe njengokufanele kusikhalo esikhulu sokuphatha kwe-vials noma ukwenza i-freeze drying. Amaphuzu ayo aphela kufana nezinto zokugcina kwe-air flow eziyenzelwe, amafiltara okugcina kwe-ultra-low particulate air, imithombo yokucleana kwe-vapor hydrogen peroxide, nokugcina kwabantu ngokugcina kwe-body protective clothing. Konke lokho kufanele kubhekwe ngokuphelele ngokusebenzisa i-media fill tests futhi kubhekwe kabusha ngokusebenzisa i-continuous environmental monitoring programs.

Ukuziphocusa kuphela kubukho lwemithombo akuyiyo indlela eyodwa. Ngokwesifundo esisondelwe ngu-FDA, ngama-60 percenti yezibonelo zokugcina izinto eziphelele ziyaphuma kubukho lwemithombo lwemikroba, kungakho kubukho lwemithombo kuphela. Lokhu kubonisa ukuthi izindawo eziphelele kufanele zinikeze okuningi kunezidingo zokufundwa ngu-ISO 14644-1. Uma sibona ngokwempilo, izindawo eziphelele ezincane ziyizindlela ezingafanele kusetyenziswa emisebenzini yokuproducwa. Kodwa ukulinda okuphelele kubukho lwemithombo kuyizindawo eziphelele ezingafanele, ezinikeza ukulinda okuphelele. Lezi zindawo ezingafanele ziyizikhathi ezingcono ezinikeza ukulinda okuphelele okuphambili kwezidingo zokufundwa ukuze zinikeze ubuhle bokuproducwa.

Izihlangothi nezinhlelo zokwenza izinto ngokuphelele: Phakathi kwezinye izinhlelo, ukulinda kubukho lwemithombo kubhekiswe phambili kubukho lwemithombo lwemikroba

Ukuphumelela kwezinhlangano zokwenza izinkampani zezinhlobo zezinto ezincane ziyisisekelo esikhulu kwezinhlangano zokwenza izinhlobo zezinto ezincane, futhi akukho mlando wokubheka amaseli amancane. Isiphephelo esinye sasezinkampani esisodwa ngemitha yezinkampani ezingaphezu kwe-0.1 microns singathwala isibonelo sesibhakabhaka sokugcina isibhakabhaka futhi singavula izinto ezinokuthi zibe nesilinganiso sezinkampani ezingu-50,000. Ngokuthi lokhu kuyisibhakabhaka, izinkampani zonke zokwenza izinhlobo zezinto ezincane zizihlalela izindleko zabo ngaphandle kwezinkampani zokwenza izinhlobo zezinto ezincane eziyisikhali se-ISO Class 3 ukuze 5, ezinamafiltela ase-ULPA. Bazihlalela ukusuka kwamafutha ngokusebenza kwezindleko zokuhamba kwezifutha ngokufana noma ngokuhamba kwezifutha ngokuphambuka ngokuphambuka, kusukela kusuka kwezindleko zokusebenza zokuhamba kwezifutha. Ukusebenzisa izinto ziyasebenzisa izindleko ezikhulu. Kepha, ngaphandle kwezinkampani zokwenza izinhlobo zezinto ezincane zokubheka amaseli amancane, lezi zindawo azikho zokubheka ngokuphathelene nokubheka amaseli amancane ngokuphathelene nokubheka izindleko zokubheka izinto zokuvikela, noma ukubheka okunye okuhlanganisa ukuvikela izinto ngokuphathelene nokubheka izinto zokuvikela.

Kumazwe amabili njengokwenza amaphakathi amahle okukhanya nokubhala amaphakathi ase- aerospace, ukugcina izinombolo zezinto ezingenani kakhulu kuyisisekelo sokugcina izinhlamvu zokufana kwezinye izinyathelo zokuphakama kwe-nanoscale. Amaseli akhona akhathazekile kule mibuzo ngokuphelele, ngakho ukuthenga imali engaphezu kwezindawo zokuhlala ezihlakanipile kuyisisekelo esingavumelekile lapha ngoba kudibanisa izindlela zokuthinteka nezinkinga ezingenakwazi ukuthi ziyisiphi isiphumo. Uma kufundwa phakathi kwezindawo zokuhlala ezihlakanipile noma kwezindawo zokuhlala eziphakeme, abasebenzi bafanele ukubuza ubunzima obubhekene nalo. Uma ubunzima bokubaluleka kwemithombo yobuhlungu kuyisisekelo, kuyadingeka ukuthi kwenziwe ukuvavanywa, ukubhabhisa ngokuphelele, nokwenza izindlela zokuthinteka ngokuphelele. Kodwa uma kubhekene nezinto ezingenani ezikhipha kakhulu, isikhundla sokuqonda kusuka kwezinhlobo zokugcina, izindlela zokufiltera komoya ngokuphelele, nokugcina ngokuphelele kuyisisekelo esifanele kanye nesisekelo sokuthinta ngokuphelele.

Imibuzo Evame Ukubuzwa

Ukuchaza okuphakathi kwekhaya elihle nekhaya elisilisa kubani?

Ikheya elihle libhekisele kuukuthintela kwezinto eziphakathi kwamafutha, futhi libhekisele emithethweni ye-ISO 14644-1. Ngakolunye uhlangothi, ikheya elisilisa libhekisele ukususa izinhlobo zezinhlobo zokuhlwa, futhi libhekisele emithethweni emikhulu kakhulu njenge-EU GMP Annex 1, okufanele kube nesikhundla esisilisa ngokuphelele (SAL) sokulwa.

Kungani ukulwazi ngokuhlwa kuyisisekelo esibalulekileyo ekhayeni elisilisa?

Ukulwazi ngokuhlwa kuyisisekelo esibalulekileyo ekhayeni elisilisa ukuze sicinane ukuthi akukho izinhlobo zezinhlobo zokuhlwa ezingavumelekileyo ozokubonakalisa ubuhle bokuprodukha, isibonelo, emizini yezinkampani zokuphatha amadragi apho ukuthintela kungabangela izinkinga ezinkulu zokuhlwa kwabantu.

Lapha kufanele sebenziswe ikheya elisilisa ngaphandle kokheya elihle?

Amakhaya okukhupha kuyizimangaliso zokusebenza okuzodinga ukukhupha kwesifaniso, njengokwenza amadragi ayo akhuphwa ngokugcina nezinto zokubaluleka, ngakho-ke amakhaya okuhlanzwa ayisifanele kumsebenzi wokwenza amaphutha we-semiconductor nezinto zokuhlaziya ngokuphelele, lapho ukulawula izinye zezinto zokuhlanzwa kuyisifundiswa esiphambili.