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Sterile Test Isolators

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.

The handling is carried out through glove interventions
Sterility test pump
Sterility test pump in the inner chamber of the isolator
Logging and control of processes takes place via intuitive touch panel interface

Highest Safety For Testing For Sterility

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.

 

Closed System for Aseptic Processes

Ortner Plus Symbolgrafik

Ortner PLUS

  • Fully integrated glove and isolator leak test according to ISO 14644-7
  • Automated ambient & online particle monitoring
  • Fully automated LOG6 H2O2 decontamination with logging
  • Integrated H2O2 gas generator for stable decontamination processes
  • Interior chamber design of the isolator flexibly adaptable
  • Touch panel for operation and monitoring of the processes
  • Electrically height-adjustable seat/stand workstation (+/- 150 mm)
  • Low noise level of < 60 dB (A)
  • Plug & Play system

Ergonomic

Electrically height- adjustable sit-stand workstation (+/- 150 mm) ensures the comfort of personnel working in the isolator.

Equipment Inner Chamber

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.

Transfer Lock for Inward and Outward Transfer

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.

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:

Laminar Flow Velocity | Pressure | Temperature | Humidity

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.

Fully Automatic Bio- Decontamination

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.

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.

High- Security Protection System in Positive Pressure Mode for Sterile Testing of Aseptically Produced Drugs

Technical Data

Overall Data of the Sterile Test Isolator

Clean room class at installation site: ISO 8/ D or better
Weight of the system incl. 2- Glove/ 4-Glove airlocks: approx. 900 kg/ 1100 kg

Media Connections

Electrical: 3 x 400 V/ 50 Hz/ 8 kW
Compressed air: H14 filtered 6 bar [2:2:2], 400 L/ min
Exhaust air/ supply air: 150 to 300 m³/ h (parameterizable)

Control and Monitoring

Intuitive touch screen user interface: 9"
PLC model: Siemens S7- 1500

Technical Data

Protection Class

Primary: Product protection
Secondary: Personal & environmental protection

Isolator Chambers (work area)

Clean room class in the isolator chamber: ISO 5/ A
Front pane glass type/ sealing system: ESG 15 mm/ dynamic
Tightness class of the isolator chamber according to ISO EN 14644-7: 4
Material of the surfaces touched by the product: 1.4404 Ra < 0.80 µm
Illuminance in the working area: > 650 LUX
Air pressure in the isolator chamber (SET): 10 to 100 Pa (parameterizable)
Protectivefilter circulating air: HEPA H14
Removable bottom: 3 pieces
Sterile test pump: fully integrated

Technical Data

Isolator Supply Air Module

Rectified flow (TAV): 0.3 to 0.45 m/s +/-20% (parameterizable)
Mainfilter stage: HEPA H14

Lock

Air pressure in the airlock (SET): 10 to 100 Pa (parameterizable)
Protective filter recirculation/exhaust air: HEPA H14
Design of the door to the protection module: sliding door, pneum. operated
Design of the door to the ambient room: revolving door, manual, dynamically sealed

Technical Data

H2O2 Decontamination

Isolator ready for H2O2 decontamination
Decontamination level: LOG 6 reduction

Integrated H2O2 Gas Generator "ISU Compact"

Storable cycles: 1-10 (optionally expandable)
Pump: high precision metering pump
Reproducibility: +/- 1
Scale: 0 - 6000 g
Visualization: external- via isolator
Injection rate: 1-10 g / min
Volume flow: variable up to 60 m3/h
H2O2 reservoir: up to 5 liters (technically pure H2O2)

Weitere Informationen

Additional Options

  • Fully automatic glove testing device with port recognition and logging
  • Height adjustable isolator
  • Material lock right/ left with fully automatic bio- decontamination
  • Integrated H2O2 gas generator with catalyst
  • Air cooler for precise temperature control incl. control and monitoring 
  • 230 V sockets, USB or RS432 connection in the isolator chamber
  • Shelf system 150 mm deep

Additional Options

  • Integrated online particle monitoring for 0.5 and 5 μm, with logging 
  • Air sampler integrated
  • Temperature and humidity monitoring integrated
  • H2O2 concentration measurement HC/ LC sensor
  • Intercom system with surveillance camera
  • Touch panel 19 
  • Remote maintenance access
  • Audit trail

Additional Options

  • Central user administration
  • OPC- DA client coupling to the higher- level system 
  • RTP port
  • RTP beta port endless liner
  • ABL filter, UML filter 
  • Integrated sterile test pump 
  • Fluid reservoir for one pump 
  • ICH9 risk assessment and GMP qualification IQ/ OQ
  • GAMP5 computer validation

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