Product Description
The hard cabin laminar flow type aseptic isolator is a hard-walled structure composed of stainless steel and tempered glass, and the internal environment is dynamic A-level. Use gloves for operation. The gloves can be thickened and anti-breakage or thin and high-feeling; the system is equipped with a Siemens logic controller (PLC) for fully automatic control of pressure and air flow, and has a pressure loss alarm function. Industrial-grade tablet computer control meets the verification requirements of the 2010 version of the GMP computer system.
Performance characteristics
1. Dry vaporized hydrogen peroxide (VHPS*) sterilization, reaching the 6-log spore killing level, with the function of monitoring and controlling the concentration of hydrogen peroxide;
2. The interior of the cabin is cleaned by manual wiping, and there is no dead angle;
3. The VHPS concentration in the cabin after ventilation is less than 1ppm, which can meet the VHPS residual concentration detection;
4. After sterilization, the cabin body is in full compliance with GMPA level cleanliness standards, and online dust particles and planktonic bacteria sampling systems can be integrated and installed;
5. The cabin body pressure reduction test, under 2 times the test pressure, the hourly volume leakage rate is less than 0.5%; it has a leakage alarm function;
6. The isolator can be adjusted according to the needs of use-80pa~80pa, the normal product maintains 40pa~60pa during aseptic operation, the pressure is maintained to the set value ±5pa under static conditions, and the two modes of positive pressure and negative pressure can be preset and stored , Adjust according to demand;
7. The system design meets the requirements of GMP, 2015 Pharmacopoeia, USP/EP, and the control system can meet the 21CFR part11 electronic signature and electronic record requirements;
- The air source is clean filtered compressed air or nitrogen, and the air source pressure is 0.4MPa~0.6MPa.
Specification
| Name |
VHP Aseptic Isolator |
| Power |
380±38V, 50±5Hz, 25A |
| Maximum power |
≤4000W |
| Built-in bacteria collector |
1-2 |
| Airflow method |
Unidirectional flow |
| Display |
12.1 inch tablet |
| Noise |
<65dB(A) |
| Application |
Aseptic filling, sampling |
| Internal environment |
Class A |
| System |
PLC |
| Cusom |
Provided |
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
){kind=link}
){kind=link}