Chipinda Choyera cha ISO 7 GMP Pharmaceutical
Mafotokozedwe Akatundu
Chipinda choyera chamankhwala chimagwiritsidwa ntchito makamaka mumafuta odzola, olimba, amadzimadzi, kulowetsedwa, ndi zina. GMP ndi ISO 14644 muyezo nthawi zambiri zimaganiziridwa pamundawu. Cholinga chake ndikumanga malo asayansi komanso okhwima opanda ukhondo, njira, magwiridwe antchito ndi kasamalidwe ndikuchotsa zonse zomwe zingatheke komanso zomwe zingatheke pachilengedwe, tinthu tating'onoting'ono komanso kuipitsidwa kwapakatikati kuti apange mankhwala apamwamba komanso aukhondo. Ayenera kuyang'ana pa mfundo yofunika kwambiri yoyendetsera chilengedwe ndikugwiritsa ntchito ukadaulo watsopano wopulumutsa mphamvu ngati njira yomwe amakonda. Ikatsimikiziridwa ndikuyenerera, iyenera kuvomerezedwa ndi Food and Drug Administration kaye isanapangidwe. Mayankho aukadaulo oyeretsa zipinda za GMP ndi ukadaulo wowongolera kuipitsidwa ndi njira imodzi yayikulu yowonetsetsa kuti GMP ikuyendetsedwa bwino. Monga akatswiri opangira njira zosinthira chipinda choyeretsa, titha kupereka chithandizo cha GMP kuyambira pokonzekera koyambirira mpaka kugwira ntchito komaliza monga kuyenda kwa ogwira ntchito ndi njira zoyendetsera zinthu, dongosolo lazipinda zoyera, dongosolo loyera la HVAC, makina oyera azipinda, makina owunikira zipinda zoyera. , makina opangira mapaipi, ndi ntchito zina zonse zothandizira kukhazikitsa, ndi zina zotero. Titha kupereka njira zothetsera chilengedwe zomwe zimagwirizana ndi GMP, Fed 209D, ISO14644 ndi EN1822 miyezo yapadziko lonse, ndikugwiritsa ntchito luso lopulumutsa mphamvu.
Technical Data Sheet
|
Kalasi ya ISO | Max Part / m3 |
Mabakiteriya oyandama cfu/m3 |
Kuyika Bakiteriya (ø900mm)cfu/4h | Surface Microorganism | ||||
| State Static | Dynamic State | Kukhudza (o55mm) cfu/dish | 5 Magolovesi a Zala cfu/magolovesi | |||||
| ≥0.5µm | ≥5.0 µm | ≥0.5µm | ≥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 | / |
Zambiri Zamalonda
Chigawo cha Kapangidwe
• Sambani khoma ndi siling'i
•Yeletsani chitseko cha chipinda ndi zenera
•Yeretsani mbiri ya rom ndi hanger
• Epoxy pansi
Gawo la HVAC
•Chigawo chothandizira mpweya
• Perekani cholowera mpweya ndi kubweza mpweya
• Njira ya mpweya
•Zida zodzitetezera
Gawo lamagetsi
•Kuyeretsa Kuwala Kuchipinda
•Sinthani ndi soketi
•Mawaya ndi chingwe
•Bokosi logawa mphamvu
Control Part
•Ukhondo wa mpweya
•Kutentha ndi chinyezi chambiri
•Mayendedwe ampweya
•Kupanikizika kosiyana
Turnkey Solutions
Kukonzekera & Kupanga
Titha kupereka malangizo akatswiri
ndi njira yabwino ya engineering.
Kupanga & Kutumiza
Titha kupereka mankhwala apamwamba kwambiri
ndipo fufuzani mokwanira musanapereke.
Kuyika ndi Kutumiza
Titha kupereka magulu akunja
kuonetsetsa kuti ntchitoyo ikuyenda bwino.
Kutsimikizira & Maphunziro
Titha kupereka zida zoyesera kuti
kupeza mulingo wovomerezeka.
Zambiri zaife
•Zazaka zopitilira 20, zophatikizidwa ndi R&D, kapangidwe, kupanga ndi kugulitsa;
•Takhala ndi makasitomala opitilira 200 m'maiko opitilira 60;
•Yovomerezedwa ndi ISO 9001 ndi ISO 14001 management system.
• Clean room project turnkey solution provider;
•Utumiki woyimitsa kamodzi kuchokera pakupanga koyamba mpaka kugwira ntchito komaliza;
• Minda yayikulu 6 monga mankhwala, labotale, zamagetsi, chipatala, chakudya, zida zamankhwala, ndi zina.
• Kuyeretsa chipinda chopangira mankhwala ndi ogulitsa;
•Anapeza ma patent ambiri ndi ziphaso za CE ndi CQC;
• Zopangira zazikulu za 8 monga gulu loyera lachipinda, khomo loyera lachipinda, fyuluta ya hepa, FFU, bokosi lachiphaso, shawa la mpweya, benchi yoyera, malo oyezera, etc.
Malo Opangira
Chiwonetsero cha Zamalonda
FAQ
Q:Kodi projekiti yanu yakuchipinda chaukhondo itenga nthawi yayitali bwanji?
A:Kawirikawiri ndi theka la chaka kuchokera ku mapangidwe oyambirira kupita ku ntchito yabwino, ndi zina zotero.
Q:Ndi chiyani chomwe mukujambula pazipinda zanu zaukhondo?
A:Nthawi zambiri timagawaniza zojambula zathu m'magawo 4 monga gawo lamapangidwe, gawo la HVAC, gawo lamagetsi ndi gawo lowongolera.
Q:Kodi mungakonzekere anthu aku China kupita kumalo akunja kukamanga zipinda zoyera?
A:Inde, tidzakonza ndipo tidzayesetsa kuchita zonse zomwe tingathe kuti tidutse pulogalamu ya VISA.
Q: Kodi zinthu zakuchipinda zanu zoyera zitha kukhala zokonzeka nthawi yayitali bwanji?
A:Nthawi zambiri umakhala mwezi umodzi ndipo zitha kukhala masiku 45 ngati AHU ingagulidwe m'chipinda choyerachi.
