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Sterile isolator aseptic negative pressure isolator

Brief introduction
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 a
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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;
 
  1. 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
Cell Phone: 0086-15800947006
https://medigrade.en.made-in-china.com/ made-in-china.com
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