Your safety is our priority
Containment Isolator
FEATURES
-
OEB 4 or OEB5
-
Chamber Integrity: ISO10648-2
-
H14 cylinder HEPA filters (PUSH-PUSH)
-
Continuous liner bag system for a material safety transfer
-
Siemens PLC control with HMI
-
Automatic control and operation
-
Real-time monitoring the differential pressure, humidity, temperature
-
Critical process parameters can be stored and printed.
-
21 CFR Part 11 compliance
-
Air change ＞24 times/h, turbulent flow
-
Can be installed in background Class D
-
Power Supply: AC220V or 380V/50Hz
-
Pressure range: -80Pa~-50Pa
OPTIONS
-
Laminar flow
-
Bag-In-Bag-Out(BIBO) H14 HEPA filters
-
Explosion-proof
-
The vibration-free platform for precision weighing
-
WiFi controlled glove integrity tester (GIT-WLAN)
-
Wooden Mock-Up
Aseptic Isolator
FEATURES
-
Class A, ISO5, Aseptic environment.
-
Integrated VHPS® decontamination system.
-
Special liquid transfer technology for continuous and aseptic filling.
-
Real-time monitoring of the velocity, differential pressure, humidity, temperature.
-
Temperature is adjustable to minimize the influence on products.
-
Critical process parameters can be stored and printed.
-
Power Supply: AC 380V/50Hz
-
Siemens PLC control with HMI
-
The leakage rate is less than 0.5% /vol/hour at 2 times the working pressure
-
LED lamp, more than 300 Lux
OPTIONS
-
Rapid Transfer Ports (RTP) technology for safe transfer.
-
Particle counter
-
Air sampler
-
H2O2 high & low concentration sensors
-
H2O2 portable sensor for operator safety
-
WiFi controlled glove integrity tester (GIT-WLAN)
-
Wooden Mock-Up
Documentation
-
Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11.
-
FAT, SAT, IQ, OQ Training.