I-ISO 7 GMP yeGumbi eliCocekileyo loPhando
Ingcaciso yeMveliso
Igumbi elicocekileyo le-Pharmaceutical lisetyenziswa ikakhulu kwi-ointment, eqinile, isiraphu, i-infusion set, njl njl. I-GMP kunye ne-ISO 14644 esemgangathweni idla ngokuqwalaselwa kule ntsimi. Okujoliswe kuko kukwakha ubume begumbi lobunzululwazi kunye nobungqongqo obungenazintsholongwane, inkqubo, ukusebenza kunye nenkqubo yolawulo kunye nokuphelisa ngokugqithisileyo yonke into enokwenzeka kunye nenokwenzeka yebhayoloji, isuntswana lothuli kunye nokungcoliseka okunqamlezayo ukuze kwenziwe imveliso yechiza ekumgangatho ophezulu kunye necocekileyo. Kufuneka kugxininiswe kwindawo ephambili yolawulo lokusingqongileyo kwaye kusetyenziswe iteknoloji entsha yokonga amandla njengokhetho olukhethiweyo. Xa ekugqibeleni iqinisekisiwe kwaye ifanelekile, kufuneka ivunywe nguLawulo lokuTya kunye neDrug lasekhaya kuqala ngaphambi kokuba ifakwe kwimveliso. Izisombululo zobunjineli begumbi lokucoca amayeza e-GMP kunye netekhnoloji yolawulo longcoliseko yenye yeendlela eziphambili zokuqinisekisa ukuphunyezwa ngempumelelo kwe-GMP. Njengomboneleli wesisombululo segumbi elicocekileyo elicocekileyo, sinokubonelela ngenkonzo yokumisa enye ye-GMP ukusuka kucwangciso lokuqala ukuya ekusebenzeni kokugqibela njengokuhamba kwabasebenzi kunye nezisombululo zokuhamba kwezinto, inkqubo yegumbi elicocekileyo, inkqubo yeHVAC ecocekileyo, inkqubo yombane yegumbi elicocekileyo, inkqubo yokubeka iliso kwigumbi elicocekileyo. , inkqubo yemibhobho, kunye nezinye iinkonzo ezixhasayo ufakelo lulonke, njl. Sinokubonelela ngezisombululo zokusingqongileyo ezithobela iGMP, iFed 209D, ISO14644 kunye ne-EN1822 imigangatho yamazwe ngamazwe, kwaye sisebenzise iteknoloji yokonga amandla.
Iphepha leDatha lobuGcisa
|
ISO Class | Isuntswana eliphezulu/m3 |
Iintsholongwane ezidadayo cfu/m3 |
Ukufakwa kweBakteria (ø900mm)cfu/4h | Surface Microorganism | ||||
| Ilizwe elingatshintshiyo | Ilizwe eliDynamic | Chukumisa (ø55mm) cfu/isitya | Iiglavu zeminwe ezi-5 cfu/iiglavu | |||||
| ≥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 | / |
| ISO 8 | 3520000 | 29000 | / | / | 200 | 100 | 50 | / |
Iinkcukacha zeMveliso
Icandelo lolwakhiwo
•Coca udonga lwegumbi kunye nesilingi panel
•Coca umnyango wegumbi kunye nefestile
•Coca iprofayili ye-rom kunye ne-hanger
• Umgangatho we-epoxy
Inxalenye yeHVAC
•Iyunithi yokuphatha umoya
•Bonelela indawo yomoya kunye nokubuyisela indawo yokuphuma yomoya
• Umbhobho womoya
•Izixhobo zokugquma
Icandelo loMbane
•Coca isibane seGumbi
•Iswitshi kunye nesokethi
•Iingcingo kunye neentambo
•Ibhokisi yokuhambisa amandla
ICandelo loLawulo
•Ucoceko lomoya
•Iqondo lobushushu kunye nokufuma
•Ukuhamba komoya
•Uxinzelelo olwahlukileyo
Turnkey Solutions
Ukucwangcisa & noYilo
Sinako ukunika iingcebiso zobungcali
kunye nesona sisombululo sobunjineli.
Imveliso & nokuhanjiswa
Sinokubonelela ngemveliso ekumgangatho ophezulu
kwaye wenze uhlolo olupheleleyo phambi kokunikezelwa.
Ukuhlohla nokuYayelwa
Singabonelela ngamaqela aphesheya
ukuqinisekisa ukusebenza ngempumelelo.
Ukuqinisekiswa noQeqesho
Sinokubonelela ngezixhobo zokuvavanya
ukufikelela umgangatho oqinisekisiweyo.
Ngathi
•Ngaphezu kwama-20 eminyaka yamava, adityaniswe ne-R&D, uyilo, ukuvelisa kunye neentengiso;
•Kuqokelelwe abathengi abangaphezu kwama-200 kumazwe angaphezu kwama-60;
•Igunyaziswe yi-ISO 9001 kunye ne-ISO 14001 inkqubo yolawulo.
•Coca umnikezeli wesisombululo seprojekthi yegumbi;
• Inkonzo yokumisa enye ukusuka kuyilo lokuqala ukuya ekusebenzeni kokugqibela;
• Iinkalo ezi-6 ezingundoqo ezifana nezamayeza, ilabhoratri, i-elektroniki, isibhedlele, ukutya, izixhobo zonyango, njl.
•Coca umenzi wemveliso yegumbi kunye nomthengisi;
•Ufumene amalungelo awodwa omenzi wechiza kunye nezatifiketi zeCE kunye neCQC;
• Iimveliso eziphambili ze-8 ezifana nepaneli yegumbi elicocekileyo, umnyango wegumbi elicocekileyo, i-hepa filter, i-FFU, ibhokisi yokudlula, ishawa yomoya, ibhentshi ecocekileyo, i-booth yokulinganisa, njl.
Isixhobo soMveliso
Umboniso weMveliso
FAQ
Q:Ingaba iprojekthi yakho yegumbi elicocekileyo iya kuthatha ixesha elingakanani?
A:Ngokuqhelekileyo isiqingatha sonyaka ukusuka kuyilo lokuqala ukuya ekusebenzeni ngempumelelo, njl njl. Kwakhona kuxhomekeke kwindawo yeprojekthi, ububanzi bomsebenzi, njl.
Q:Yintoni ebandakanyiweyo kwimizobo yoyilo lwegumbi elicocekileyo?
A:Ngokuqhelekileyo sihlula imidwebo yethu yoyilo kwi-4 inxalenye efana nesakhiwo, inxalenye ye-HVAC, inxalenye yombane kunye nenxalenye yokulawula.
Q:Ngaba ungalungiselela abasebenzi baseTshayina kwindawo yaphesheya ukuze benze ulwakhiwo lwamagumbi acocekileyo?
A:Ewe, siya kuyicwangcisa kwaye siya kuzama konke okusemandleni ethu ukuphumelela isicelo se-VISA.
Q: Ingahlala ixesha elingakanani imathiriyeli yegumbi lakho elicocekileyo kunye nezixhobo?
A:Idla ngokuba yinyanga e-1 kwaye iya kuba ziintsuku ezingama-45 ukuba i-AHU ithengwe kule projekthi yegumbi elicocekileyo.
