Sterility Test Isolator
It is used for sterile testing , weighing, dispensing and transferring for the sterile substance with toxicity to ensure the reliable sterile environment.
Main features
Sterile test isolator is a sealing system, through fan filter unit (high efficiency filter , HEPA)to realize the air safe exchange and achieve the online monitoring of particles and microorganisms in the inner environment. Use quickly transfer channels or air brakes to aseptic transfer of materials and ensure the protection between the operator and the drug, and can handle 1-6 operators at the same time.
Equipped with Millipore sterility tester, it saves a lot of time for checking. It has H2O2 pass box, which is suitable for multiple batch sample testing.
Fully meet the requirements of USP/EP/CHP sterility testing regulations, stable performance, ensure the quality of drug testing.
Parameters of samples are monitored and recorded, they can be either directly sent to a printer(option) or stored on a remote PC.
Technical parameters
| Item |
Isolator (soft) |
Isolator(stainless steel) |
API sampling isolator |
| Production capacity |
8-10batches/day |
8-10batches/day |
8hours*7days |
| Motor power |
5-7kw |
5-7kw |
4-0.8kw |
| Total power |
0.4-0.8kw/h |
4-0.8kw/h |
5-15kw/h |
| Power supply |
380V±38V/50±1Hz/60Hz |
| Dimension |
3019×1000×2390 |
2508×1100×2500 |
2800×855×2800 |
| Material |
PVC,SS316L, cover ss304 |
SS316L/304 |
SS316L/304 |
| Weight |
400kg |
600kg |
700kg |
| Noise |
≤70db(A) |
| OEL |
OEB5 |
| Air speed |
0.36-0.54m/s |
| Laminar flow |
Vertical unidirectional flow/Turbulent flow |
| Tem/humidity online monitoring |
Yes |
| Working pressure |
+45~-150Pa |
| Cleanliness level |
A class environment |
| Structure mode |
Modular + Expansion port |
| Leakage rate |
≤0.25%Vol/h |
| Illumination |
≥500Lux |
| Inner cavity material |
PVC |
AISI316L |
AISI316L |
| Outside material |
PVC |
AISI304 |
AISI304 |
| H2O2 sterilizing time |
≤90min |
| Sterilization effect |
6LOG |
| Sterilization method |
Hydrogen peroxide vapor |
| Sterilization concentration |
>300PPM |
| Standard for residual VHP concentration after sterilization |
≤1PPM |
| Classification during equipment operation |
A LEVEL |
If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
medigrade.en.made-in-china.com
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