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Aseptic Processing Isolator System
Réf : AP-IS | Fabricant : Tema Sinergie
The AP-IS is a cGMP Class A/ISO 5 isolator system specifically designed for QC labs, pilot scale pharmaceutical production and pharmacies.
It’s a flexible equipment that guarantees the best working conditions in different applications such as Sterility Testing, Aseptic Filling, Aseptic Dispensing & Sampling and Aseptic Product Transfer
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 polishe
- 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