ISO 7 GMP Pharmaceutical Clean Room
Incazelo Yomkhiqizo
Igumbi elihlanzekile lezemithi lisetshenziswa kakhulu kumafutha, okuqinile, isiraphu, isethi yokumnika, njll. I-GMP kanye ne-ISO 14644 standard ngokuvamile ibhekwa kulo mkhakha. Umgomo uwukwakha imvelo yegumbi elihlanzekile nehlanzekile eliqinile, inqubo, ukusebenza kanye nohlelo lokuphatha futhi kuqedwe ngokwedlulele yonke into engenzeka kanye nengenzeka yebhayoloji, izinhlayiya zothuli kanye nokunukubezeka okuphambanayo ukuze kwenziwe umkhiqizo wezidakamizwa osezingeni eliphezulu futhi ohlanzekile. Kufanele igxile ephuzwini elibalulekile lokulawulwa kwemvelo futhi isebenzise ubuchwepheshe obusha bokonga amandla njengendlela ekhethwayo. Lapho ekugcineni isiqinisekisiwe futhi ifaneleka, kufanele igunyazwe ngabaPhathi Bendawo Bokudla Nezidakamizwa kuqala ngaphambi kokuthi ifakwe ekukhiqizweni. Izixazululo zobunjiniyela begumbi elihlanzekile le-GMP kanye nobuchwepheshe bokulawula ukungcoliswa kungenye yezindlela eziyinhloko zokuqinisekisa ukuqaliswa ngempumelelo kwe-GMP. Njengomhlinzeki wesixazululo se-turnkey yegumbi elihlanzekile, singahlinzeka ngesevisi ye-GMP eyodwa-stop kusukela ekuhleleni kokuqala kuya ekusebenzeni kokugcina njengokugeleza kwabasebenzi nezixazululo zokugeleza kwezinto, uhlelo lwesakhiwo segumbi elihlanzekile, uhlelo lwe-HVAC lwegumbi elihlanzekile, uhlelo lukagesi lwegumbi elihlanzekile, uhlelo lokuqapha igumbi elihlanzekile. , isistimu yamapayipi okucubungula, kanye nezinye izinsiza ezisekela ukufakwa sekukonke, njll. Singahlinzeka ngezixazululo zemvelo ezithobela i-GMP, i-Fed 209D, ISO14644 kanye ne-EN1822 izindinganiso zamazwe ngamazwe, futhi sisebenzise ubuchwepheshe okonga amandla.
Ishidi Ledatha Yezobuchwepheshe
|
I-ISO Class | I-Max Particle/m3 |
Amagciwane antantayo cfu/m3 |
Amagciwane Afakayo (ø900mm)cfu/4h | I-Surface Microorganism | ||||
| Isimo Esiqinile | Isimo Esinamandla | Thinta(ø55mm) cfu/dish | 5 Amagilavu eminwe cfu/amagilavu | |||||
| ≥0.5 µm | ≥5.0 µm | ≥0.5 µm | ≥5.0 µm | |||||
| ISO 5 | 3520 | 20 | 3520 | 20 | ＜1 | ＜1 | ＜1 | ＜1 |
| ISO 6 | 3520 | 29 | 352000 | 2900 | 10 | 5 | 5 | 5 |
| ISO 7 | 352000 | 2900 | 3520000 | 29000 | 100 | 50 | 25 | / |
| I-ISO 8 | 3520000 | 29000 | / | / | 200 | 100 | 50 | / |
Imininingwane Yomkhiqizo
Ingxenye Yesakhiwo
•Hlanza udonga lwegumbi kanye nephaneli yosilingi
•Hlanza umnyango wegumbi kanye nefasitela
•Hlanza iphrofayili ye-rom ne-hanger
•Iphansi le-epoxy
Ingxenye ye-HVAC
•Iyunithi yokuphatha umoya
•Faka indawo yokufaka umoya bese ubuyisela indawo yomoya
•Ipayipi lomoya
•Impahla yokuvikela ukushisa
Ingxenye kagesi
•Hlanza Ukukhanya Kwegumbi
•Shintsha kanye nesokhethi
•Izintambo nekhebuli
•Ibhokisi lokusabalalisa amandla
Ingxenye Yokulawula
•Ukuhlanzeka komoya
• Izinga lokushisa kanye nomswakama ohlobene
•Ukungena komoya
•Ingcindezi ehlukile
Izixazululo ze-Turnkey
Ukuhlela nokuklama
Singanikeza iseluleko sochwepheshe
kanye nesixazululo esihle kakhulu sobunjiniyela.
Ukukhiqiza Nokulethwa
Singahlinzeka ngomkhiqizo wekhwalithi ephezulu
futhi uhlole ngokugcwele ngaphambi kokulethwa.
Ukufaka&Ukuthunywa
Singahlinzeka ngamaqembu aphesheya kwezilwandle
ukuqinisekisa ukusebenza ngempumelelo.
Ukuqinisekisa nokuqeqeshwa
Singahlinzeka ngezisetshenziswa zokuhlola ku
finyelela izinga eliqinisekisiwe.
Mayelana NATHI
•Isipiliyoni seminyaka engaphezu kwengu-20, esihlanganiswe ne-R&D, ukuklama, ukukhiqiza nokudayisa;
•Iqoqe amaklayenti angaphezu kuka-200 emazweni angaphezu kuka-60;
•Kugunyazwe i-ISO 9001 kanye nohlelo lokuphatha lwe-ISO 14001.
• Hlanza iphrojekthi yegumbi umhlinzeki wesixazululo se-turnkey;
•Isevisi eyodwa-stop kusukela ekwakhiweni kokuqala kuya ekusebenzeni kokugcina;
•Izinkambu ezi-6 eziyinhloko njengezemithi, ilabhorethri, i-electronic, isibhedlela, ukudla, idivaysi yezokwelapha, njll.
• Hlanza igumbi lokukhiqiza umkhiqizo kanye nomphakeli;
•Ithole inala yamalungelo obunikazi kanye nezitifiketi ze-CE ne-CQC;
•Imikhiqizo eyinhloko engu-8 njengephaneli yegumbi elihlanzekile, umnyango wegumbi ohlanzekile, isihlungi se-hepa, i-FFU, ibhokisi lokudlula, ishawa yomoya, ibhentshi elihlanzekile, idokodo lokukala, njll.
Indawo Yokukhiqiza
Isibonisi somkhiqizo
FAQ
Q:Iphrojekthi yakho yegumbi elihlanzekile izothatha isikhathi esingakanani?
A:Ngokuvamile kuyingxenye yonyaka kusukela ekwakhiweni kokuqala kuya ekusebenzeni okuyimpumelelo, njll. Kubuye kuncike endaweni yephrojekthi, ububanzi bomsebenzi, njll.
Q:Yini efakiwe emidwebo yedizayini yegumbi lakho elihlanzekile?
A:Ngokuvamile sihlukanisa imidwebo yethu yokuklama ibe izingxenye ezingu-4 njengengxenye yesakhiwo, ingxenye ye-HVAC, ingxenye kagesi kanye nengxenye yokulawula.
Q:Ungakwazi yini ukuhlela abasebenzi baseShayina baye esizeni saphesheya kwezilwandle ukuze wenze ukwakhiwa kwegumbi elihlanzekile?
A:Yebo, sizoyihlela futhi sizozama konke okusemandleni ethu ukudlulisa isicelo se-VISA.
Q: Impahla yegumbi lakho elihlanzekile kanye nezinto zokusebenza zingalunga isikhathi esingakanani?
A:Ngokuvamile kuba yinyanga engu-1 futhi kungaba izinsuku ezingu-45 uma i-AHU ithengwa kule phrojekthi yegumbi elihlanzekile.
