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Sterility Testing Isolator System
Réf : ST-IS | Fabricant : Tema Sinergie
The ST-IS is a cGMP Class A/ISO 5 modular isolator system specifically designed for Sterility Testing, which guarantees the safest working conditions during QC Operations.
GUARANTEED ASEPSIS
MODULAR BASED CONFIGURATION
AUTOMATIC LEAK TEST
EASE OF MAINTENANCE
ERGONOMIC DESIGN
GLOVE INTEGRITY TESTING
DATA MANAGEMENT
Key features
- Fully PLC controlled isolator system
- Modular configuration concept of the system
- Integrated VPHP generator and distribution circuit
- VPHP resistant anemometer
- VPHP resistant relative humidity and temperature (rH%+T) sensor
- External monolithic Control Cabinet made of AISI 304 stainless steel
- View/Access panel latches with integrated safety switches
- LED lighting system
Specifications
- Main shell structure made of high-grade AISI 316L stainless steel
- Sheathings and support structure made of AISI 304 stainless steel
- Mirror Brite internal finishing (<0,3 µm), and Scotch Brite external finishing (<0,8 µm)
- Weldings ground, smoothed and polished
- Integrated SCADA – iFIX with Historian DMS available upon customer request as option
- SIMATIC HMI TP700 Comfort Siemens, 7” Touch Panel with TFT colour widescreen display
- PLC Siemens S7-1500
- 21 CFR part 11 compliant
- GAMP compliant software development
- VPN connection for a secure and private communication via Internet network – remote access and assistance, updates, maintenance and training