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Closed system for sterile testing of pharmaceutical products.
Sterility testing under aseptic conditions. Sterile test isolators from Ortner are modular, closed systems for performing sterility tests under aseptic conditions.
An overpressure (10 to 100 Pa) prevails in the sterile test isolator to prevent particles from the installation room from entering the isolator and contaminating the product in the event of a minimal leakage.
Easy loading and unloading of connected airlocks. For loading and unloading of materials, a quick- acting airlock can be connected to the left as well as to the right of the isolator. Internal automatic sliding doors allow easy loading and unloading of the airlocks. In addition, the system is designed so that the isolator can be used for both product and personnel protection.
The isolator can be operated via an intuitively structured interface via touchscreen. All processes can additionally be controlled and monitored via visualizations.
Sterile test isolators from Ortner ensure safe working conditions according to GMP Class A.
The integrated, fully automatic H2O2 decontamination around LOG6 germ reduction guarantees aseptic working conditions in the isolator.
Safe decontamination of the H2O2 before the start of the test ensures that sterility testing is carried out with the exclusion of false- negative results.
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 hanging system, precision balance, sterile test pump, removable false bottom, etc.
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 transfer gate can be connected to the left and/or right side of the isolator as required.
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:
Laminar Flow Velocity | Pressure | Temperature | Humidity
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.
Fast and safe 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.
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.
Technical Data
Technical Data
Technical Data
Additional Options
Additional Options
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