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Ortner - Aseptic Isolators
For highly sensitive products. Aseptic isolators are modular, closed systems for the aseptic manufacture, processing and manipulation of highly sensitive materials and products. They are particularly suitable for use in pharmacy or in hospital pharmacies.
An overpressure (10 to 100 Pa) in the isolator prevents, in the event of a minimal leakage, particles from the installation room getting into the isolator and contaminating the product.
The system is designed in such a way that it can be used for product and/or personal protection.
To protect people and material. A fast airlock can be connected to the left and right of the isolator to transfer materials in and out. Internal, automatic sliding doors allow easy loading and unloading of the locks.
The isolator can be operated via an intuitively structured surface via touchscreen. All processes can also be controlled and monitored via visualisations.
Maximum safety for the product
Ortner aseptic isolators ensure safe working conditions according to GMP class A.
The special air flow and handling via glove ports guarantee a safe separation of operator and process.
Fully automatic leak tests of the system tightness, an integrated compressed air-powered H2O2 gas generator for fully automatic bio-decontamination as well as process monitoring and logging contribute to ensuring constant environmental control as well as complete operator and process safety.
Environmental Monitoring
Monitoring plays an increasing role in ensuring safety and quality during the manufacturing process. All Ortner isolator systems have a fully integrated online monitoring system for the following measured values:
ergonomics
An electrically height-adjustable sit-stand workstation (+/- 150 mm) ensures the well-being of the staff when working in the isolator.
FurnishingThe inner chamber of the isolator can be equipped with a wide variety of equipment - such as B. particle monitoring, USB ports, sterile test pump, etc.
Transfer sluice for loading and unloadingMaterials are brought in and taken out via transfer locks. The transfer locks or fast locks are an important interface between the isolator and the environment.
A quick sluice can be connected to the isolator on the left and/or right as desired.
Continuous particle monitoring
Particle monitoring is one of the most important parameters in GMP monitoring and is used to monitor air purity. The Ortner isolators have a fully integrated, user-friendly online particle measurement system for particle sizes of 0.5 μm and 5.0 μm.
The measurement is activated during production. The particle concentration in the isolator is measured over the entire production time.
- Clean room class at the installation site: ISO 8 / D or better
- Weight of the system including locks 2-Glove / 4-Glove: approx. 900 kg / 1200 kg
- Electrical: 3 x 400 V / 50 Hz / 8 kW
- Compressed air: H14 filtered 6 bar [2:2:2], 400 L/min
- Extract air/supply air: 150 to 300 m³/h (configurable)
- Clean room class in the isolator chamber: ISO 5 / A
- Windscreen glass type/sealing system: ESG 15 mm/dynamic
- Tightness class of the isolator chamber according to ISO EN 14644-7: 3 - 4
- Material of the surfaces in contact with the product: 1.4404 Ra < 0.80 µm
- Illuminance in the working area: > 650 LUX
- Air pressure in the isolator chamber (TARGET): 10 to 100 Pa (parameterizable)
- Protective filter recirculation: HEPA H14
- Removable bottom: 3 pieces
- Sterile test pump: fully integrated
- Primary: product protection
- Secondary: personal and environmental protection
- Directional flow (TAV): 0.3 to 0.45 m/s +/-20% (configurable)
- Main filter stage: HEPA H14
- Air pressure in the lock (TARGET): 10 to 100 Pa (parameterizable)
- Protective filter for recirculation/exhaust air: HEPA H14
- Version of the door to the protection module: sliding door, pneum. operated
- Design of the door to the surrounding area: revolving door, manual, dynamically sealed
- Isolator for H2O2 decontamination: ready
- Decontamination level: LOG 6 reduction
- Cycles that can be saved: 1-10 (optionally expandable)
- Pump: High precision metering pump
- Reproducibility: +/- 1%
- Scale: 0 - 6000g
- Visualization: external - via isolator
- Injection Rate: 1-10g/min
- Volume flow: variable up to 60 m3/h
- H2O2 reservoir: up to 5 liters (technically pure H2O2)