Kunshan Kazhengke Mechanical Engineering Co., Ltd.
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Biopharmaceutical tsabtace bita
Biopharmaceutical tsabtace bita
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Manufar kamfanonin kwayoyin halitta da ke buƙatar GMP ita ce tabbatar da kafa yanayin samar da kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin kwayoyin Abin da muke kira biopharmaceutical tsabtace injiniya-GMP tsabtace masana'antu injiniya mafita da gurɓataccen kula da fasaha ne daya daga cikin manyan hanyoyin da za a tabbatar da nasarar aiwatar da GMP;

Ta hanyar zurfin bincike da ƙwarewar injiniya da aka tara a kan yanayin samar da abokan cinikin biopharmaceutical, mun fahimci mahimmancin sarrafa muhalli na tsarin samar da biopharmaceutical; Ajiye makamashi shine fifiko ga tsarinmu; Mafi kyawun abin da muke da shi ne samar da abokan ciniki daidai da GMP da Fed 209D, ISO14644, IEST, EN1822 kasa da kasa ka'idodin bukatun, yayin da ake amfani da sabon makamashi ceton fasahar muhalli mafita; Za mu iya samar da cikakken masana'antu tsara zane daga GMP - mutane tafiya kayan aiki tsabtace tsari, tsabtace iska kwandishoning tsarin, tsabtace ado tsarin; Dukkanin masana'antu makamashi ceton gyara, ruwa da wutar lantarki, ultra tsabta gas bututun, tsabtace dakin sa ido, kula da tsarin da sauran cikakken shigarwa goyon bayan sabis;


Bio tsabtace dakuna da suka shafi ka'idoji

Standard Sunan

tsabtace matakin

Mai tsabtace dakin gwaji

HEPA tace maki

HEPA tace gwajin

Amurka FDA / GMP

US FED 209 D&E

IEST-RP-CC006.3
IEST-RP-CC023.1

IES-RP-CC001.4

IEST-RP-CC006.3
IEST-RP-CC0021.2
IEST-RP-CC0034.2

Tarayyar Turai / GMP

GGMP EEC AnnexX1
ISO14644

ISO 14644-2&3
ISO 14698

EN 1822

EN1822

kasar Sin GMP-2011

FED 209 D&E
SO 14644-1

GB 50073-2001
GB/T 16292-2010
GB/T16293-2010
GB/T 16294-2010

GB/T 13554-2008

GB/T 6165-2008

Biopharmaceutical tsabtace injiniya-GMP tsabtace masana'antu injiniya bayani:
I. Bayani
XX kamfanin bio sterile samar da bita, ginin ne 121x18 mita, duk uku-hawa karfe kankare gine-gine masana'antu, daya-hawa yankin 2268 M2. farko samar da bita ne a gaban yammacin bene, ginin ne 5 mita, beam kasa tsayi 4.2 mita; Tare da allura gyaran yankin bita zane ceiling tsayi 3.0m, sauran yankuna ne 2.6m; Kasuwancin kasa, 2.4 mita tsakanin kayan aiki. Yawancin samar da na'urorin da ake amfani da su guda ɗaya don maganin lafiya. An tsara don 100,000 Level Domain + Air Conditioning yankin.

1) <Dokokin Gudanar da Ingancin Samar da Magunguna> (An gyara Ma'aikatar Lafiya a 1992);

2) <Tsarin Tsarin Tsarin Masana'antun Magunguna> (1997)

3) <Dokokin Gudanar da Samar da Magunguna (() Jagorar Aikacewa> (1992)

4) <Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Tsarin Ts

5) <Heating iska da kuma iska sanyaya zane bayanai> (GBJ19-87)

6) <Bayani game da sarrafa kayan aikin likita > YY / T-0033-90

7) A bangare samar da tsari jirgin sama layout zane da sauran m fasaha bayanai;

3, samar da bita bisa ga samar da tsari da kayayyakin ingancin bukatun, raba zuwa general samar da yankin, sarrafa yankin da. Ma'aikata canza takalma yankin, maza da mata daya, biyu tufafi dakin, wanke hannu, hannu saniya, wanke dakin, iska shawa tashar, tsabtace mutane tafiya, kayan aiki kaya tafiya, allura dakin, rubber matsa bushe ƙura, tsakiyar ajiya, taro dakin, ciki marufi dakin, waje marufi dakin da inji dakin, kayan aiki da sauransu. Injin dakin yana cikin ƙaramin ɗaki na sama na bene na uku, yana buƙatar yin maganin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfin ƙarfe; sanyaya hasumiyar da kuma sanyaya famfo sanya a kan sama na uku bene; Kayan aikin aiki kaya ya dace da bukatun bene.

IV, ma'aikata motsi shugabanci: canza takalma, canza tufafi, wanke hannu, hannu sterilization - iska shawa tashar - tsabtace corridor - tsabtace bita

Kafa ƙofofin tsaro a wuraren tsaftacewa da hanyoyin aiki don sauƙaƙe kwararar ma'aikata.

Item tafiya shugabanci: kayan aiki tashar ----- tsabtace bita ----- gama marufi

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