ISO 7 GMP Pharmaceutical Yakachena Kamuri
Product Description
Pharmaceutical yakachena kamuri inonyanya kushandiswa mukuzora, yakasimba, sirasi, infusion seti, nezvimwe. GMP uye ISO 14644 chiyero chinowanzotariswa mumunda uyu. Chinangwa ndechekuvaka sainzi uye yakasimba isina kuchena yekamuri nharaunda, maitiro, mashandisiro uye manejimendi system uye kubvisa zvakanyanya zvese zvinogoneka uye zvingangoita biological chiitiko, guruva chidimbu uye kusvibiswa kwemuchinjiko kuitira kugadzira chemhando yepamusoro uye ine hutsanana chigadzirwa chemishonga. Inofanirwa kutarisa pane yakakosha poindi yekudzora kwezvakatipoteredza uye kushandisa ichangoburwa-yekuchengetedza simba tekinoroji senge sarudzo yakasarudzika. Kana yazosimbiswa uye inokodzera, inofanirwa kubvumidzwa neChikafu neDrug Administration yekutanga isati yaiswa mukugadzira. GMP mishonga yakachena kamuri mainjiniya mhinduro uye kusvibiswa kwekudzora tekinoroji ndiyo imwe yenzira huru dzekuona kubudirira kwekuita kweGMP. Senyanzvi yakachena yekamuri turnkey mhinduro, tinogona kupa GMP imwe-yekumira sevhisi kubva pakuronga kwekutanga kusvika kwekupedzisira kushanda sekuyerera kwevashandi uye kuyerera kwezvinhu, yakachena kamuri chimiro system, yakachena kamuri HVAC system, yakachena kamuri yemagetsi system, yakachena kamuri yekutarisa system. , gadziriso yepombi system, uye mamwe ese akazara kuisirwa anotsigira masevhisi, nezvimwewo. Tinogona kupa zvigadziriso zvezvakatipoteredza zvinoenderana neGMP, Fed 209D, ISO14644 uye EN1822 mazinga epasi rose, uye kushandisa. teknolojia yekuchengetedza simba.
Technical Data Sheet
|
ISO Kirasi | Max Particle/m3 |
Hutachiona hunoyangarara cfu/m3 |
Kuisa Utachiona (ø900mm)cfu/4h | Surface Microorganism | ||||
| Static State | Dynamic State | Bata(ø55mm) cfu/dish | 5 Finger Gloves cfu/girovhosi | |||||
| ≥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 | / |
Product Details
Chimiro Chikamu
•Chenesa madziro ekamuri uye sirin'i panel
•Chenesa gonhi rekamuri nehwindo
•Chenesa rom profile uye hanger
•Epoxy pasi
Chikamu cheHVAC
• Air handling unit
•Ipai mhepo inopinza uye uye dzosera inobuditsa mweya
•Nhepfenyuro yemhepo
•Insulation zvinhu
Electrical Part
•Clean Room Light
•Chinja uye socket
•Waya netambo
•Simba rekugovera bhokisi
Kudzora Chikamu
•Kuchena kwemhepo
•Tembiricha uye hunyoro hunoenderana
•Kuyerera kwemhepo
•Kudzvinyirirwa kwakasiyana
Turnkey Solutions
Kuronga & Kugadzira
Tinogona kupa mazano enyanzvi
uye yakanakisa engineering mhinduro.
Production&Delivery
Tinogona kupa chigadzirwa chemhando yepamusoro
uye ongorora zvizere usati wasununguka.
Installation&Commissioning
Tinogona kupa zvikwata zvemhiri kwemakungwa
kuve nechokwadi chekubudirira kushanda.
Validation&Kudzidziswa
Tinogona kupa midziyo yekuedza ku
kuwana yakasimbiswa mwero.
Nezvedu
•Kupfuura 20 makore 'chiitiko, chakabatanidzwa neR&D, dhizaini, kugadzira uye kutengesa;
• Yakaunganidza pamusoro pe200 vatengi munyika dzinopfuura makumi matanhatu;
• Yakatenderwa ne ISO 9001 uye ISO 14001 manejimendi system.
• Yakachena kamuri purojekiti turnkey mhinduro mupi;
•One-stop service kubva pakugadzirwa kwekutanga kusvika pakushanda kwekupedzisira;
• 6 minda mikuru yakadai semishonga, marabhoritari, zvemagetsi, chipatara, chikafu, mudziyo wekurapa, nezvimwe.
• Yakachena kamuri chigadzirwa mugadziri uye mutengesi;
•Kuwana akawanda patents uye CE neCQC zvitupa;
• 8 michina mikuru yakadai seyakachena kamuri panel, yakachena kamuri gonhi, hepa sefa, FFU, pass box, air shower, yakachena bhenji, kuyera dumba, etc.
Production Facility
Product Display
FAQ
Q:Inguva yakareba sei basa rako rekamuri rakachena richatora?
A:Inowanzova hafu yegore kubva pakugadzirwa kwekutanga kusvika pakushanda kwakabudirira, etc. Izvo zvinoenderanawo nenzvimbo yeprojekti, nzvimbo yebasa, nezvimwewo.
Q:Chii chinosanganisirwa mukamuri rako rakachena dhizaini?
A:Isu tinowanzo kupatsanura dhizaini yedu muzvikamu zvina senge chikamu chechimiro, chikamu cheHVAC, chikamu chemagetsi uye chikamu chekutonga.
Q:Unogona here kuronga vashandi veChinese kunzvimbo yemhiri kwemakungwa kuti uvake dzimba dzakachena?
A:Ehe, isu tichazvironga uye isu tichaedza zvatinogona kuti tipfuure VISA application.
Q: Inguva yakareba sei zvinhu zvako zvemukamuri yakachena uye midziyo zvingave zvakagadzirirwa?
A:Zvinowanzoita mwedzi mumwe uye angave mazuva makumi mana nemashanu kana AHU ikatengwa muchirongwa chekamuri iyi yakachena.
