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Tailin - Model HTY-CPS - Cell and Gene Therapy Isolator
Design based on stringent GMP aseptic production requirements and meets the requirements of various regulatory agencies (FDA, EMA, NMPA) regulations and industry guidelines (ISO, PDA, USP, Chinese Pharmacopoeia).Customized Solutions for ATMP Products R&D and Production
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
Leakage rate is less than 0.5% /vol/hour at 2 times working pressure
LED lamp, more than 300 Lux
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
Cell and Gene Therapy Isolator systems can be custom designed to suit individual customer requirements.
Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11.
FAT, SAT, Training.