Sterility Test Isolators
A quick-acting airlock allows easy loading and unloading of materials, while a fully automated H₂O₂-decontamination process (LOG6 germ reduction) guarantees reliable sterilisation before testing. The system is intuitively controlled via touchscreen and features comprehensive environmental monitoring.
The decontamination process is carried out using dried compressed air, reducing the risk of condensate formation during the process.
Ortner Sterile Test Isolator
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Sterility Test Isolators
Ortner Sterile Test Isolator
Key Features & Benefits
The Sterility Test Isolator provides the highest safety for testing sterility.
- Integrated H₂O₂ gas generator ensures LOG6 bio-decontamination with complete process monitoring and logging.
- Real-time tracking of laminar airflow, pressure, temperature, humidity, and particle levels.
- Electrically height-adjustable workstation (+/- 150 mm) and intuitive touchscreen interface for seamless operation.
- The inner chamber of the isolator can be equipped with various equipment- such as hanging system, precision balance, sterile test pump, removable false bottom, etc.
Continuous Particle Monitoring
Particle monitoring is a critical parameter in GMP monitoring and is used to monitor air purity. Ortner isolators are equipped with a fully integrated, user-friendly online particle measurement system for 0.5 μm and 5.0 μm particle sizes. The monitoring is active during production operation, with particle concentrations measured continuously throughout the entire production process.
Configurations
Specifications | Values |
|---|---|
| Model | 2-Glove Isolator (Customisable) & 4-Glove Isolator (Customisable) |
| Weight | 2-Glove Isolator: Approx. 900 kg | 4-Glove Isolator: Approx. 1100 kg |
| Power Supply | 3 x 400 V / 50 Hz / 8 kW |
| Compressed Air | H14 filtered; 6 bar [2:2:2]; 400 L/min |
| Supply/Exhaust Air | 150 – 300 m³/h; parameterisable |
| Additional Options | Integrated H₂O₂ gas generator with fully automatic material lock decontamination | Glove testing with port detection; CCTV surveillance; intercom; remote access | USB/RS232 integration; OPC UA system connection; GMP/ICH9 qualification | Sterile test pump; shelving system; fluid reservoir; RTP port solutions. |
Customisbale Options
- Automated glove testing & logging
- Additional airlocks with bio-decontamination
- Integrated temperature & humidity monitoring
- Remote maintenance access & audit trail
- Intercom system with surveillance camera
- Fully adjustable isolator height
- Additional RTP ports & electrical connections
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