Igumbi elihlanzekile le-ISO 7 GMP Phambanisa
Ukuchazwa Komkhiqizo
Igumbi elihlanzekile lemithi lisetshenziswa ikakhulukazi kumafutha, eliqinile, isiraphu, ukumnika, ukumnika okufakiwe, njll. I-GMP kanye ne-ISO 14644 Okujwayelekile kuvame ukubhekwa kulo mkhakha. Inkomba yokwakha imvelo ehlanzekile yesayensi futhi eqinile, inqubo, uhlelo lokusebenza kanye nokuphatha futhi isusa kakhulu yonke imisebenzi yemvelo engenzeka futhi engahle ibe khona, izinhlayiya zothuli kanye nokuthwebula umkhiqizo wekhwalithi ephezulu nenhlanzeko. Kufanele ugxile endaweni ebalulekile yokulawulwa kwemvelo futhi usebenzise ubuchwepheshe obusha okonga amandla njengenketho oyithandayo. Lapho ekugcineni kuqinisekiswa futhi kufanelekile, kufanele kuvunyelwe ukuphathwa kokudla kwasendaweni kanye nokuphathwa kwezidakamizwa kuqala ngaphambi kokukhiqiza. Izixazululo Zobunjiniyela be-GMP Pharmaceutical Clean I-Engineering kanye nobuchwepheshe bokulawula ukungcoliswa yinye yezindlela eziphambili zokuqinisekisa ukuqaliswa ngempumelelo kwe-GMP. Njengomhlinzeki wesisombululo sokuhlanza igumbi elihlanzekile, singanikeza insizakalo yokumisa i-GMP eyodwa kusuka ekusebenzeni kokuqala okufana nokugeleza kwabasebenzi, uhlelo lwe-Clead HVAC, uhlelo lokuhlanza igumbi elihlanzekile, uhlelo lokuhlola igumbi elihlanzekile, uhlelo lokuhlola igumbi elihlanzekile, uhlelo lokuhlola igumbi elihlanzekile , cubungula uhlelo lwamapayipi, nezinye izinsizakalo zokuxhasa okuphelele, njll. Singahlinzeka ngezixazululo zezemvelo ezihambisana ne-GMP, eDod 209D, i-ISO1422 Amazinga wamazwe aphesheya, futhi faka ubuchwepheshe bonga amandla.
Ishidi ledatha yezobuchwepheshe
|
Isigaba se-ISO | I-Max Particle / m3 |
Amagciwane antantayo CFU / M3 |
Ukufaka ama-Bacteria (Ø900mm) CFU / 4H | I-Surface Microorganism | ||||
| Isimo se-static | Isimo esinamandla | Thinta (Ø55mm) CFU / Dish | I-5 gloves Finger CFU / Gloves | |||||
| ≥0.5 μm | ≥5.0 μm | ≥0.5 μm | ≥5.0 μm | |||||
| Iso 5 | I-3520 | 20 | I-3520 | 20 | <1 | <1 | <1 | <1 |
| ISO 6 | I-3520 | 29 | I-352000 | 2900 | 10 | 5 | 5 | 5 |
| Iso 7 | I-352000 | 2900 | I-3520000 | I-29000 | 100 | 50 | 25 | / |
| Iso 8 | I-3520000 | I-29000 | / | / | -Mashumi | 100 | 50 | / |
Imininingwane Yomkhiqizo
Hlela ingxenye
• Udonga lwegumbi elihlanzekile nophahla lwephaneli
• Igumbi lokuhlanza igumbi nefasitela
• Hlanza iphrofayili ye-ROM ne-hanger
• I-Epoxy Phansi
Ingxenye ye-HVAC
• Iyunithi yokuphatha umoya
• Nikela ukungena komoya kanye nokubuyisa ukuphuma komoya
• I-Air Duct
• Indwangu yokufakelwa
Ingxenye kagesi
• Ukukhanya kwegumbi elihlanzekile
• Shintsha nesokhethi
• Izintambo nentambo
• Ibhokisi Lokusabalalisa Amandla
Ukulawula Ingxenye
• Ukuhlanzeka komoya
• Ukushisa kanye nomswakama ohlobene
•Ukungena komoya
• Ingcindezi ehlukile
Izixazululo ze-turnkey
Ukuhlela nokwakhiwa
Singanikeza izeluleko zochwepheshe
kanye nekhambi lobunjiniyela obuhle kakhulu.
Ukukhiqiza nokulethwa
Singanikeza umkhiqizo osezingeni eliphezulu
futhi uhlole ngokuphelele ngaphambi kokulethwa.
Ukufaka & Ukukhomishini
Singanikeza amaqembu aphesheya kwezilwandle
ukuqiniseka ukuthi ukusebenza ngempumelelo.
Ukuqinisekiswa Nokuqeqeshwa
Singanikeza amathuluzi wokuhlola ukuze
ukufezekisa okujwayelekile okulinganiselwe.
Mayelana NATHI
• Okuhlangenwe nakho kweminyaka engama-20, kuhlanganiswe ne-R & D, design, ukukhiqiza nokuthengisa;
• Kuqoqwe amaklayenti angaphezu kwama-200 emazweni angaphezu kwama-60;
• Kugunyazwe yi-ISO 9001 ne-ISO 14001 Management System.
• Umhlinzeki Wezixazululo Zomhlinzeki Wokuhlanza I-Clean Prefruss Turnkey;
• Inkonzo yokumisa eyodwa kusuka kumklamo wokuqala wokusebenza kokugcina;
• Izinkambu ezi-6 eziphambili ezinjenge-Pharmaceutical, elebhu, elebhu, elektroniki, isibhedlela, ukudla, idivaysi yezokwelapha, njll.
• Umkhiqizi womkhiqizo wekamelo ohlanzekile nomhlinzeki;
• Kutholwe amalungelo amaningi amalungelo obunikazi kanye nezitifiketi ze-CQC;
• Imikhiqizo engu-8 eyinhloko efana nephaneli yegumbi elihlanzekile, umnyango wekamelo elihlanzekile, isihlungi se-hepa, i-FFU, ibhokisi lokuphasa, ukugeza komoya, i-clohch enesisindo, njll.
Indawo yokukhiqiza
Ukuboniswa Komkhiqizo
Umthandi
Q:Ngabe iphrojekthi yakho yegumbi elihlanzekile izothatha isikhathi esingakanani?
A:Imvamisa unyaka nonyaka ukusuka ekwakhiweni kokuqala kokusebenza okuphumelelayo, njll. Futhi kuya ngephrojekthi, umkhawulo womsebenzi, njll.
Q:Yini efakiwe kwimidwebo yakho yegumbi elihlanzekile?
A:Imvamisa sihlukanisa imidwebo yethu yokwakhiwa ibe yingxenye engu-4 efana nesakhiwo ingxenye, ingxenye ye-HVAC, ingxenye kagesi nengxenye yokulawula.
Q:Ungakwazi ukuhlela ukusebenza kwamaShayina kusayithi laphesheya ukuze kwenziwe ukwakhiwa kwamakamelo ahlanzekile?
A:Yebo, sizoyihlela futhi sizozama konke okusemandleni ethu ukudlula isicelo se-visa.
Q: Igumbi lakho lekamelo lakho elihlanzekile lingase lilungele isikhathi esingakanani?
A:Ngokuvamile kuvame ukufika ezinyangeni ezingama-1 futhi kungaba izinsuku ezingama-45 uma kuthengwe ku-Ahu kule projekthi yegumbi elihlanzekile.
