Igumbi Lokuhlanza Lemithi le-ISO 7 GMP
Incazelo Yomkhiqizo
Igumbi lokuhlanza lemithi lisetshenziswa kakhulu ekugcotshweni, okuqinile, isiraphu, isethi yokufaka, njll. Izinga le-GMP kanye ne-ISO 14644 zivame ukucatshangelwa kulo mkhakha. Inhloso ukwakha indawo ehlanzekile yegumbi ehlanzekile ngokwesayensi nangokuqinile, inqubo, ukusebenza kanye nohlelo lokuphatha kanye nokuqeda yonke imisebenzi engaba khona neyezinto eziphilayo, izinhlayiya zothuli kanye nokungcola okuphambene ukuze kukhiqizwe umkhiqizo wemithi osezingeni eliphezulu nohlanzekile. Kufanele kugxilwe ephuzwini elibalulekile lokulawula imvelo futhi kusetshenziswe ubuchwepheshe obusha bokonga amandla njengenketho ekhethwayo. Uma sekuqinisekisiwe futhi sekufanelekile, kumele kuvunyelwe yi-Food and Drug Administration yendawo kuqala ngaphambi kokufakwa ekukhiqizweni. Izixazululo zobunjiniyela begumbi lokuhlanza lemithi ye-GMP kanye nobuchwepheshe bokulawula ukungcola kungenye yezindlela eziyinhloko zokuqinisekisa ukuqaliswa ngempumelelo kwe-GMP. Njengomhlinzeki wezixazululo ze-turnkey ochwepheshe wegumbi lokuhlanza, singanikeza isevisi ye-GMP eyodwa kusukela ekuhleleni kokuqala kuya ekusebenzeni kokugcina njengezixazululo zokugeleza kwabasebenzi kanye nokugeleza kwezinto, uhlelo lokwakha igumbi lokuhlanza, uhlelo lwe-HVAC lwegumbi lokuhlanza, uhlelo lukagesi lwegumbi lokuhlanza, uhlelo lokuqapha igumbi lokuhlanza, uhlelo lwamapayipi okucubungula, kanye nezinye izinsizakalo zokusekela ukufakwa, njll. Singanikeza izixazululo zemvelo ezihambisana nezindinganiso zomhlaba wonke ze-GMP, i-Fed 209D, i-ISO14644 kanye ne-EN1822, futhi sisebenzise ubuchwepheshe bokonga amandla.
Ishidi Ledatha Lobuchwepheshe
|
Ikilasi le-ISO | Ubuningi be-Particle/m3 |
Amabhaktheriya antantayo cfu/m3 |
Ukufaka Amabhaktheriya (ø900mm)cfu/4h | Izinto ezincane ezingaphandle | ||||
| Isimo Esimile | Isimo Esiguqukayo | Ukuthinta (ø55mm) i-cfu/isitsha | Amagilavu eminwe ama-5 cfu/amagilavu | |||||
| ≥0.5 µm | ≥5.0 µm | ≥0.5 µm | ≥5.0 µm | |||||
| I-ISO 5 | 3520 | 20 | 3520 | 20 | 1 | 1 | 1 | 1 |
| I-ISO 6 | 3520 | 29 | 352000 | 2900 | 10 | 5 | 5 | 5 |
| I-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 yophahla
•Hlanza umnyango nefasitela legumbi
•Hlanza iphrofayili ye-rom kanye ne-hanger
•Iphansi le-Epoxy
Ingxenye ye-HVAC
•Iyunithi yokuphatha umoya
• Nikeza indawo yokungenisa umoya kanye nendawo yokukhipha umoya ebuyayo
•Umsele womoya
•Izinto zokuvala umoya
Ingxenye Kagesi
•Isibani Segumbi Esihlanzekile
• Iswishi kanye nesokhethi
•Izintambo nekhebula
•Ibhokisi lokusabalalisa amandla
Ingxenye Yokulawula
•Ukuhlanzeka komoya
•Izinga lokushisa kanye nomswakama ohlobene
•Ukungena komoya
•Ingcindezi yokwehluka
Izixazululo ze-Turnkey
Ukuhlela Nokuklama
Singanikeza iseluleko sochwepheshe
kanye nesisombululo sobunjiniyela esingcono kakhulu.
Ukukhiqiza Nokulethwa
Singanikeza umkhiqizo osezingeni eliphezulu
futhi uhlole ngokuphelele ngaphambi kokulethwa.
Ukufakwa Nokuthunywa
Singahlinzeka ngamaqembu aphesheya kwezilwandle
ukuqinisekisa ukuthi ukusebenza kuyaphumelela.
Ukuqinisekiswa Nokuqeqeshwa
Singahlinzeka ngamathuluzi okuhlola ku
finyelela izinga eliqinisekisiwe.
Mayelana NATHI
•Isipiliyoni seminyaka engaphezu kwengu-20, esihlanganiswe ne-R&D, ukuklama, ukukhiqiza kanye nokuthengisa;
•Kuqoqwe amakhasimende angaphezu kuka-200 emazweni angaphezu kuka-60;
•Kugunyazwe yi-ISO 9001 kanye nohlelo lokuphatha lwe-ISO 14001.
•Umhlinzeki wezixazululo zephrojekthi yegumbi elihlanzekile;
•Insizakalo yokuma okukodwa kusukela ekwakhiweni kokuqala kuya ekusebenzeni kokugcina;
•Imikhakha emi-6 eyinhloko njengezemithi, ilabhorethri, i-elekthronikhi, isibhedlela, ukudla, idivayisi yezokwelapha, njll.
•Umkhiqizi kanye nomhlinzeki wemikhiqizo yegumbi elihlanzekile;
•Ngithole amalungelo obunikazi amaningi kanye nezitifiketi ze-CE kanye ne-CQC;
•Imikhiqizo eyisishiyagalombili eyinhloko njengephaneli yegumbi elihlanzekile, umnyango wegumbi ohlanzekile, isihlungi se-hepa, i-FFU, ibhokisi lokuhambisa, ishawa yomoya, ibhentshi elihlanzekile, idokodo lokukala, njll.
Indawo Yokukhiqiza
Ukuboniswa Komkhiqizo
Imibuzo Evame Ukubuzwa
Q:Iphrojekthi yakho yokuhlanza igumbi izothatha isikhathi esingakanani?
A:Ngokuvamile kuba yisigamu sonyaka kusukela ekwakhiweni kokuqala kuya ekusebenzeni okuphumelelayo, njll. Kuncike futhi endaweni yephrojekthi, ububanzi bomsebenzi, njll.
Q:Yini efakiwe emidwebweni yakho yokuklama igumbi elihlanzekile?
A:Ngokuvamile sihlukanisa imidwebo yethu yokuklama ibe izingxenye ezine njengengxenye yesakhiwo, ingxenye ye-HVAC, ingxenye kagesi kanye nengxenye yokulawula.
Q:Ungakwazi yini ukuhlela izisebenzi zaseShayina ukuze ziyokwakha amakamelo ahlanzekile kwamanye amazwe?
A:Yebo, sizokuhlela futhi sizozama konke okusemandleni ethu ukuphumelela isicelo se-VISA.
Q: Izinto zakho zegumbi elihlanzekile kanye nemishini zingalunga isikhathi esingakanani?
A:Ngokuvamile kuba yinyanga eyodwa futhi kungaba yizinsuku ezingu-45 uma i-AHU ithengwa kulo msebenzi wegumbi elihlanzekile.
