Produits >
Modular Aseptic Containment Isolator System
Réf : AC-IS | Fabricant : Tema Sinergie
The Aseptic Containment Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).
MODULAR BASED CONFIGURATION
GUARANTEED ASEPSIS
MAXIMUM SAFETY
INTEGRATED WASH-IN-PLACE (WIP)
AUTOMATIC LEAK TEST
EASE OF MAINTENANCE
ERGONOMIC DESIGN
GLOVE INTEGRITY TESTING
DATA MANAGEMENT
Principales caractéristiques
- Fully PLC controlled isolator system
- Modular configuration concept of the system
- Integrated manual & automatic Wash-In-Place (WIP)
- 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
Spécifications
- 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
- SIMAT IC HMI TP700 Comfort Siemens, 12” Touch Panel with TFT colour widescreen display
- PLC Siemens S7-1500
- 21 CFR part 11 compliant
- GAMP compliant software development
- Integrated SCADA – iFIX with Historian DMS available upon customer request as option
- VPN connection for a secure and private communication via Internet network –remote access and assistance, updates, maintenance and training