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Closed system for toxic processes
For safe handling of highly active substances. Cytostatic isolators from Ortner are modular, closed systems for the safe production, processing and manipulation of cytostatics and other highly active substances, such as antibiotics or hormones.
When handling toxic substances, the safety of people as well as the environment is a concern. The product itself must also be protected from contamination. The use of special air ducting and work via glove intervention ensures consistent separation of the operator and the process.
Isolator in negative pressure operation. A negative pressure (-10 to -100 Pa) prevails in the cytostatic isolator, which prevents substances from escaping to the outside in the event of minimal leakage. A quick- acting airlock can be connected to the left and right of the isolator for the inward and outward transfer of materials. Internal automatic sliding doors also allow easy loading and unloading of the airlocks.
The isolator can be operated via an intuitively structured interface using a touchscreen. All processes can also be controlled and monitored via visualizations.
Cytostatic isolators from Ortner ensure safe working conditions according to GMP Class A.
The special air guidance and handling via glove intervention guarantee safe separation of operator and process.
Fully automatic leak test of system tightness, integrated compressed air driven H₂O₂-gas generator for fully automatic bio- decontamination, process monitoring and logging help to ensure continuous environmental control as well as complete operator and process safety.
Electrically height- adjustable sit- stand workstation (+/- 150 mm) ensures the comfort of personnel working in the isolator.
The inner chamber of the isolator can be equipped with various equipment- such as particle monitoring, USB ports, sterile test pump, etc.
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:
For optimum personal and product protection, Ortner uses H₂O₂-decontamination technology in its isolators. This is decontamination by means of hydrogen peroxide in an evaporated state.
The integrated, compressed air- driven H₂O₂-gas generator guarantees stable, reproducible decontamination processes.
The H₂O₂-decontamination with logging runs fully automatically- up to LOG 6 reduction- independently for each airlock and the entire system.
The integrated catalyst ensures faster decomposition of the H₂O₂.
Cycle development and cycle validation are part of the daily routine of Ortner fumigation experts and can be performed as additional services.
Materials are brought in and out via transfer locks. The transfer locks, or fast locks, are an important interface between the isolator and the environment.
A fast- acting airlock can be connected to the left and/ or right of the isolator as required.
Continuous Particle Monitoring
Particle monitoring is one of the most important parameters in GMP monitoring and is used to monitor air purity. Ortner isolators feature a fully integrated, user- friendly online particle measurement system for particle sizes 0.5 μm and 5.0 μm.
The measurement is activated during production operation and the particle concentration in the isolator is measured over the entire production time.
Cytostatics are hazardous substances with carcinogenic, mutagenic or reprotoxic effects (CMR). Ortner cytostatic isolators are used to protect the operator outside the isolator from the product as well as to protect the product itself from contamination. The special airflow and handling via glove insriff ction create a consistent separation of operator and process. Negative pressure prevails in the cytostatic isolator: Even in the event of minimal leakage, no substances can escape to the outside.
Safe and fast H₂O₂-decontamination processes.
The powerful ISU Compact integrated H₂O₂-gas generator is built directly into the isolator and ensures safe, stable bio-decontamination processes. A germ reduction of log 6 is achieved in a short time.
Compressed air driven processes. The decontamination process is operated with dried compressed air to reduce the risk of any condensate formation during decontamination.
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