Igumbi lokuCoca leMithi le-ISO 7 GMP
Ingcaciso yeMveliso
Igumbi lokucoca lamayeza lisetyenziswa kakhulu kwiointment, solid, syrup, infusion set, njl. I-GMP kunye ne-ISO 14644 standard zihlala ziqwalaselwa kweli candelo. Injongo kukwakha indawo ecocekileyo yegumbi ecocekileyo ngokwesayensi nangokungqongqo, inkqubo, ukusebenza kunye nolawulo kunye nokususa yonke imisebenzi enokwenzeka neyebhayoloji, amasuntswana othuli kunye nongcoliseko olunqamlezileyo ukuze kwenziwe imveliso yamayeza asemgangathweni ophezulu nococekileyo. Kufuneka kugxilwe kwingongoma ephambili yolawulo lokusingqongileyo kwaye kusetyenziswe iteknoloji entsha yokonga amandla njengokhetho olukhethwayo. Xa ekugqibeleni iqinisekisiwe kwaye ifanelekile, kufuneka ivunywe yi-Food and Drug Administration yasekuhlaleni kuqala ngaphambi kokuba ibekwe kwimveliso. Izisombululo zobunjineli begumbi lokucoca lamayeza e-GMP kunye netekhnoloji yokulawula ungcoliseko yenye yeendlela eziphambili zokuqinisekisa ukuphunyezwa ngempumelelo kwe-GMP. Njengomboneleli wezisombululo zegumbi elicocekileyo eliyingcali, singabonelela ngenkonzo ye-GMP enye ukusuka ekucwangcisweni kokuqala ukuya ekusebenzeni kokugqibela njengezisombululo zokuhamba kwabasebenzi kunye nokuhamba kwezinto, inkqubo yolwakhiwo lwegumbi elicocekileyo, inkqubo ye-HVAC yegumbi elicocekileyo, inkqubo yombane yegumbi elicocekileyo, inkqubo yokujonga igumbi elicocekileyo, inkqubo yemibhobho yenkqubo, kunye nezinye iinkonzo ezixhasa ukufakwa ngokubanzi, njl. Singabonelela ngezisombululo zokusingqongileyo ezihambelana nemigangatho yamazwe ngamazwe ye-GMP, i-Fed 209D, i-ISO14644 kunye ne-EN1822, kwaye sisebenzise itekhnoloji yokonga amandla.
Iphepha leDatha yoBugcisa
|
Iklasi ye-ISO | Ubuninzi beParticle/m3 |
Iintsholongwane ezidadayo cfu/m3 |
Ukufaka iintsholongwane (ø900mm)cfu/4h | Izinto ezincinci ezingaphezulu | ||||
| Imeko Engaguqukiyo | Imeko Eguqukayo | Ukuchukumisa (ø55mm) i-cfu/isitya | Iiglavu zeminwe ezi-5 ze-cfu/iiglavu | |||||
| ≥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 | / |
Iinkcukacha zeMveliso
Icandelo lesakhiwo
•Coca udonga lwegumbi kunye nephaneli yesilingi
•Coca ucango lwegumbi kunye nefestile
•Coca iprofayili ye-rom kunye ne-hanger
•Umgangatho we-epoxy
Icandelo le-HVAC
•Iyunithi yokuphatha umoya
•Nika indawo yokungenisa umoya kunye nendawo yokungenisa umoya ebuyayo
•Umbhobho womoya
•Izinto zokuvala ubushushu
Icandelo loMbane
•Ukukhanya kwegumbi okucocekileyo
• Iswitshi kunye nesokhethi
•Iingcingo kunye neentambo
•Ibhokisi yokusasazwa kwamandla
Icandelo loLawulo
•Ucoceko lomoya
•Ubushushu kunye nokufuma okulinganiselweyo
•Ukuhamba komoya
•Uxinzelelo lokwahluka
Izisombululo zeTurnkey
Ucwangciso kunye noYilo
Singakunika iingcebiso zobungcali
kunye nesisombululo sobunjineli esingcono.
Imveliso kunye nokuhanjiswa
Singabonelela ngemveliso ekumgangatho ophezulu
kwaye uhlolisise ngokupheleleyo ngaphambi kokuba uzise.
Ukufakwa kunye nokuKhomishana
Singabonelela ngamaqela aphesheya kweelwandle
ukuqinisekisa ukuba umsebenzi uphumelele.
Ukuqinisekiswa noQeqesho
Singabonelela ngezixhobo zovavanyo ukuze
fezekisa umgangatho oqinisekisiweyo.
Ngathi
•Amava angaphezu kweminyaka engama-20, adityaniswe ne-R&D, uyilo, imveliso kunye nokuthengisa;
•Kuqokelelwe abathengi abangaphezu kwama-200 kumazwe angaphezu kwama-60;
•Igunyaziswe yi-ISO 9001 kunye nenkqubo yolawulo lwe-ISO 14001.
•Umboneleli wezisombululo zeprojekthi yegumbi elicocekileyo;
•Inkonzo yokumisa yonke into ukusuka kuyilo lokuqala ukuya ekusebenzeni kokugqibela;
• Amacandelo ama-6 aphambili afana namayeza, elebhu, eletroniki, isibhedlele, ukutya, izixhobo zonyango, njl.
•Umenzi kunye nomthengisi wemveliso yegumbi elicocekileyo;
•Ndifumene amalungelo obunikazi amaninzi kunye nezatifikethi ze-CE kunye ne-CQC;
•Iimveliso ezisi-8 eziphambili ezifana nephaneli yegumbi ecocekileyo, ucango lwegumbi olucocekileyo, isihluzi se-hepa, i-FFU, ibhokisi yepasi, ishawa yomoya, ibhentshi ecocekileyo, i-weighboy, njl.njl.
Indawo yokuvelisa
Umboniso weMveliso
FAQ
Q:Iprojekthi yakho yokucoca igumbi iza kuthatha ixesha elingakanani?
A:Idla ngokuba sisiqingatha sonyaka ukusuka kuyilo lokuqala ukuya ekusebenzeni ngempumelelo, njl. Kukwaxhomekeke kwindawo yeprojekthi, ububanzi bomsebenzi, njl.
Q:Yintoni equkiweyo kwimizobo yakho yoyilo lwegumbi elicocekileyo?
A:Ngokwesiqhelo siyahlulahlula imizobo yethu yoyilo ibe ngamacandelo ama-4 afana nenxalenye yesakhiwo, inxalenye ye-HVAC, inxalenye yombane kunye nenxalenye yolawulo.
Q:Ngaba ungalungiselela abasebenzi baseTshayina ukuya phesheya ukuze basebenzele ukwakha amagumbi acocekileyo?
A:Ewe, siza kuyilungiselela kwaye siza kuzama konke okusemandleni ethu ukuphumelela isicelo se-VISA.
Q: Izinto zakho zegumbi elicocekileyo kunye nezixhobo zingalunga ixesha elingakanani?
A:Ihlala iyinyanga e-1 kwaye kuya kuba ziintsuku ezingama-45 ukuba i-AHU ithengwe kule projekthi yegumbi elicocekileyo.
