Sterility Test Isolator
Sterility Test Isolator

Sterility Test Isolator

Sterility Test Isolator feem ntau yog siv los tiv thaiv cov txheej txheem tseem ceeb xws li kuaj aseptic, aseptic khoom dispensing, thiab lwm yam. Nws yog ib tug txiv neej - tshuab cais purification khoom uas ua tau raws li qhov yuav tsum tau ntawm Class A ib puag ncig.
Xa kev nug

Taw qhia

 

Sterility Test IsolatorFeem ntau yog siv rau kev tiv thaiv cov txheej txheem tseem ceeb xws li kev kuaj aseptic, aseptic khoom dispensing, thiab lwm yam. Nws yog ib tug txiv neej - tshuab cais purification khoom uas ua tau raws li qhov yuav tsum tau ntawm Class A ib puag ncig. Nws tuaj yeem txo qhov kev xav tau ntawm ib puag ncig yav dhau los, txhim kho kev ntseeg siab ntawm cov txiaj ntsig kev xeem, ua raws li Suav GMP thiab Suav Pharmacopoeia nrog rau EU GMP / FDA cGMP / USP-NF cov cai, thiab tuaj yeem siv rau "nruam" lossis "batch" ua haujlwm.

           Sterile Isolator 2                                   Sterile Isolator 1

                                                                                        

Kev ua haujlwm nta

 

1.Tshiab VHPS thev naus laus zis: nws tuaj yeem tswj tau qhov concentration thiab saturation ntawm hydrogen peroxide, zoo reproducibility ntawm sterilization thiab shorten lub sij hawm ntawm chamber sterilization;

 

2.Modular tsim: nrog rau kev hloov pauv chamber, lub lag luam chamber, cov kab mob collector thiab lwm yam kev ua haujlwm modules thiab configurations, yooj yim rau nruab thiab thauj;

 

3.Intelligent control system: adopts Siemens PLC + IPC tswj qhov system, siab, hydrogen peroxide tov concentration, ambient kub thiab av noo, cua ceev thiab lwm yam kev soj ntsuam tsis, kom paub lub tswb ntse, lub system muaj multi - theem tswj, raws li FDA 21 CFR part 11 yuav tsum tau;

 

4. Muab cov kev pabcuam CDCV: ua kom tsis muaj menyuam txoj kev loj hlob, kev tshawb fawb thiab kev pabcuam;

 

5.Wireless hnab looj tes leak detector: tuaj yeem sib xyaw nrog cov hnab looj tes xoo hluav taws xob los yog lub hnab looj tes wireless los ntes;

 

6.Kev txuag hluav taws xob thiab kev txo qis: kev tsim kho kom zoo ntawm cov txheej txheem airflow, 8 teev ntawm kev siv hluav taws xob tas li ntawm 20%;

 

7.Real- lub sij hawm saib xyuas ntawm qhov rooj raws li txoj cai: kev saib xyuas online ntawm lub qhov rooj qhib qhov xwm txheej, kev soj ntsuam tas li ntawm qhov rooj gas sealing txheej xwm;

 

8.Decomposition lim: tso pa tawm tuaj yeem nruab nrog cov lim dej decomposition tuaj yeem ua kom lub sijhawm degradation zoo tom qab hydrogen peroxide sterilization, thiab txo cov qib ntawm sterilization residual concentration;

 

Technical Parameter

 

Cov khoom siv hauv lub chamber

316L los yog PTFE

Kev tiv thaiv qib

OEB5 qib kev tiv thaiv

Chamber polishing qib

0.4μm~0.6μm

Kev huv huv Degree

Chav Kawm A

Tswj qhov system

Siemens PLC + IPC tswj qhov system

Kev pabcuam CDCV

Muab

Cim npe nrov: Tuam Tshoj sterility test isolator lwm tus neeg, manufacturers, hoobkas