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Aseptic Isolator

Closed system for aseptic processes.

For highly sensitive products. Aseptic isolators are modular, closed systems for aseptic production, processing and manipulation of highly sensitive materials and products. They are particularly suitable for use in the pharmaceutical industry or in hospital pharmacies.

Positive pressure (10 to 100 Pa) in the isolator prevents particles from the installation room from entering the isolator and contaminating the product in case of minimal leakage.

The system is designed to be used as product and/ or personnel protection.

To protect people and materials. A quick- acting airlock can be connected to the left as well as to the right of the isolator for the entry and exit of materials. Internal automatic sliding doors 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.

Particle monitoring and USB ports in the inner chamber of the isolator
Automatic sliding doors for loading and unloading
Operation and monitoring of the isolator takes place via touch panel

Maximum Safety for Product

Aseptic 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.

Closed System for Aseptic Processes

Leak tightness test
Leak test of the system is carried out before each H2O2 decontamination
Glove- sleeve system as access device of the hermetically sealed system
Raised floor ensures the homogeneity of the laminar flow up to the working height
Ortner Plus Symbolgrafik

Ortner PLUS

  • Supply and exhaust air- independent of the building services system
  • Integrated glove and isolator leak test according to ISO 14644-7
  • Integrated sterile test pump incl. liquid waste container
  • Cooling system for temperature- labile products
  • Fully automatic LOG6 H2O2 decontamination with logging
  • Integrated H2O2 gas generator for stable decontamination processes
  • Electrically height- adjustable seat/ stand workstation (+/- 150 mm)
  • Low noise level of < 58 dB (A)
  • Plug & Play system

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

Inner chamber of an aseptic isolator

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

 

EQUIPMENT OF THE INNER CHAMBER
The inner chamber of the isolator can be equipped with various equipment- such as particle monitoring, USB ports, sterile test pump, etc.

Transfer Sluice 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 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.

Technical specifications

Overall Data of the 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/ 1200 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 specifications

Isolator Chamber (workspace)

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: 3 - 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

Protection Class

Primary: Product protection
Secondary: Personal & environmental protection

Technical specifications

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)
Protection 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 specifications

H2O2 Decontamination

Isolator for H2O2 decontamination: ready
Decontamination level: LOG 6 reduction

Integrated "ISU Compact" H2O2 Gas Generator

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

Ortners Aseptic Isolator protects the product from environmental contamination. An overpressure (10 to 100 Pa) prevails in the isolator to prevent particles from the installation room from entering the isolator in the event of minimal leakage and thus contaminating the product.

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 of H2O2 decontamination 
  • 230 V sockets, USB or RS432 connection in the isolator chamber
  • Shelf system 150 mm deep

 

 

  • 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
  • Central user administration
  • OPC- DA client coupling to the superordinate system 
  • RTP port
  • RTP beta port endless liner
  • ICH9 risk assessment and GMP qualification IQ/ OQ
  • GAMP5 computer validation

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.

Fully Automatic Bio- Decontamination