Kusukela lapho kumenyezelwa ngo-1992, "umkhuba omuhle wokukhiqiza izidakamizwa" (GMP) embonini yezemithi yaseChina kancane waqashelwa, wamukelwe futhi waqalwa ngamabhizinisi okukhiqiza amakhamishini. I-GMP inqubomgomo kazwelonke yokuphoqelelwa kwamabhizinisi, kanye namabhizinisi ahluleka ukufeza izidingo ngaphakathi komkhawulo wesikhathi ochaziwe zizoyeka ukukhiqizwa.
Okuqukethwe okuyisisekelo kwesitifiketi se-GMP ukulawulwa kokuphathwa kwekhwalithi yokukhiqizwa kwezidakamizwa. Okuqukethwe kwalo kungafingqelwa izingxenye ezimbili: ukuphathwa kwesoftware kanye nezindawo zehardware. Isakhiwo segumbi elihlanzekile kungenye yezinto ezinkulu zokutshala imali ezikhungweni zehardware. Ngemuva kokuphothulwa kwesakhiwo segumbi elihlanzekile, noma ngabe lingafinyelela izinhloso zokuqamba futhi sihlangabezane nezidingo ze-GMP kumele ziqinisekiswe ngokuhlola.
Ngesikhathi sokuhlolwa kwegumbi elihlanzekile, abanye babo bahluleka ukuhlolwa kokuhlanzeka, ezinye zazisendaweni efektri, kanti ezinye zaziwumsebenzi wonke. Uma ukuhlolwa kungafaneleki, yize bobabili abathintekayo bathole izidingo ngokulungiswa kabusha, ukulungisa iphutha, kuvame ukuchitha amandla amaningi kanye nezinsizakusebenza, futhi kubambezeleka isikhathi sokuthola isitifiketi se-GMP. Ezinye izizathu nezinkinga zingagwenywa ngaphambi kokuhlolwa. Emsebenzini wethu wangempela, sithole ukuthi izizathu eziphambili nezindlela zokuphuculwa kwentuthuko zokuhlanzeka okungafaneleki kanye nokuhluleka kwe-GMP Kubandakanya:
1. Idizayini yobunjiniyela obungenangqondo
Le nto ayivelakancane, ikakhulukazi ekwakhiweni kwamakamelo amancane ahlanzekile anezidingo eziphansi zokuhlanzeka. Umncintiswano osebunjiniyela begumbi elihlanzekile unamandla manje, kanti amanye amayunithi wokwakha anikeze izingcaphuno eziphansi kumabhidi azo ukuthola iphrojekthi. Esigabeni sakamuva sokwakhiwa, amanye amayunithi asetshenziselwa ukusika amakhona futhi asebenzise amayunithi aphansi womoya wamandla kagesi kanye nomoya omncane ngenxa yokuntula kwawo ulwazi, okuholela emandleni aphethwe kanye nendawo ehlanzekile. Esinye isizathu ukuthi umsebenzisi wengeze izidingo ezintsha nendawo ehlanzekile ngemuva kokuqamba nokwakha ukuqala, okuzokwenza nomklamo wokuqala ungakwazi ukufeza izidingo. Lesi siphambeko sokuzalwa sinzima ukuthuthuka futhi kufanele sigwenywe ngesikhathi sesigaba se-Engineering Deal Deal.
2. Ukungena esikhundleni semikhiqizo ephakeme enemikhiqizo ephansi
Ekusetshenzisweni kwezihlungi ze-HEPA emakamelweni ahlanzekile, izwe libonisa ukuthi ukwelashwa komoya okuhlanzayo ngezinga lokuhlanzeka kwe-100000 noma ngaphezulu, ukuhlunga okuphakathi kwezinga lama-tured of amabanga aphansi, aphakathi nendawo, kanye ne-hepa kufanele kusetshenziswe. Ngesikhathi senqubo yokuqinisekiswa, kwatholakala ukuthi iphrojekthi enkulu yegumbi elihlanzekile isebenzise isihlungi somoya esingezansi sokufaka esikhundleni sohlu lokuhlunga lwe-hepa endaweni yokuhlanzeka kwe-10000, okuholela ekuhlanzekeni okungafanele. Ekugcineni, isihlungi esisebenza kahle kakhulu sathathelwa indawo ukuze sihlangabezane nezidingo zesitifiketi se-GMP.
3. Ukubekwa kahle okumpofu kwe-duct enikezela ngomoya noma isihlungi
Le nto ibangelwa ukwakhiwa okunzima, futhi ngesikhathi sokwamukelwa, kungahle kubonakale sengathi igumbi elithile noma ingxenye yohlelo olufanayo alikafanele. Indlela yokwenza ngcono ukusebenzisa indlela yokuvuza yokuvuza i-duct yokuhlinzekwa komoya, futhi isihlungi sisebenzisa i-Partic counter ukuskena isigaba sesiphambano, ukubopha i-glue, nokufaka indawo yokuhlunga, nokufaka uphawu ngokucophelela.
I-4. Design Ompofu Nokuthunyelwa Kwemithi Yezindiza Yokubuyisa noma Ama-Air Vents
Ngokuya ngezizathu zokuklama, kwesinye isikhathi ngenxa yokulinganiselwa kwesikhala, ukusetshenziswa "kokubuyisana okuphezulu kwe-Supply Side Return" noma inombolo enganele yokubuyisa izindiza ama-vents akayona. Ngemuva kokuqeda izizathu zokwakhiwa, ukulungiswa kwe-return air vents nakho kuyisixhumanisi esibalulekile sokwakha. Uma ukulungiswa kokulungisa kungalungile, ukumelana nokuphuma komoya okubuyisayo kuphakeme kakhulu, futhi ivolumu yomoya yembuyiselo ingaphansi komoya womoya, kuzokwenza futhi ukuhlanzeka okungafanele. Ngaphezu kwalokho, ukuphakama kokuphuma komoya okubuyayo kusuka emhlabathini ngesikhathi sokwakha nakho kuthinta inhlanzeko.
I-5. Isikhathi esinganele sokuzihlamba sohlelo lwegumbi elihlanzekile ngesikhathi sokuhlola
NgokweZinga Likazwelonke, umzamo wokuhlola uzoqalwa imizuzu engama-30 ngemuva kohlelo lokuhlanza umoya osebenza lusebenza ngokujwayelekile. Uma isikhathi esisebenzayo sifushane kakhulu, kungadala inhlanzeko engafanele. Kulokhu, kwanele ukunweba isikhathi esisebenzayo sohlelo lokuhlanzwa komoya ngendlela efanele.
6. Uhlelo lokuhlanza umoya lokuhlanza aluzange luhlanzwe kahle
Ngesikhathi sokwakha, lonke uhlelo lokuhlanza umoya wokuhlanza, ikakhulukazi ukulethwa kanye nokubuyisa ama-ducts azondiza, akuqediwe ku-Go Oven, futhi abasebenzi bokwakha kanye nemvelo yokwakha kungadala ukungcoliswa kwezihluthulelo zomoya. Uma kungahlanzwa kahle, kuzothinta ngqo imiphumela yokuhlola. Isinyathelo Sokwenza ngcono ukuwahlanza ngenkathi sikha, nangemva kwesigaba sangaphambilini sokufakwa kwamapayipi sihlanzwa ngokuphelele, ifilimu yepulasitiki ingasetshenziswa ukusayina ukugwema ukungcoliswa okubangelwa ukungcoliswa okubangelwa yizinto ezibangelwa yizinto ezenzeka emvelweni.
7. Ukuhlanza Ukuhlanza akuhlanzwa ngokuphelele
Ngokungangabazeki, i-workshop ehlanzekile kufanele ihlanzwe kahle ngaphambi kokuhlolwa kungaqhubeka. Dinga abasebenzi bokugcina bokusula ukugqoka izingubo zomsebenzi ezihlanzekile zokuhlanza ukuqeda ukungcoliswa okubangelwa umzimba womuntu wokuhlanza. Ama-ejenti wokuhlanza angaba ngamanzi ompompi, amanzi amsulwa, izixazululo ze-organic, ama-detegents angathathi hlangothi, njll. Kulabo abanezidingo ze-anti-tuli, sula kahle ngendwangu ecwiliswe ku-anti-static ketshezi.
Isikhathi sePosi: Jul-26-2023