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Containment Isolators

For handling powdery active substances.

Protection from powdered hazardous substances. Containment isolators from Ortner provide safety during the production and handling (dosing, weighing, sieving, mixing, etc.) of airborne, powdered hazardous substances.

A negative pressure (-10 to -100 Pa) is maintained in the containment isolator to protect people from contact with the product.

Safety has priority- even when cleaning the isolator. Chamber cleaning is performed by a "wash- in- place" or "cleaning- in- place" (WIP or CIP) process. For this purpose, a fluorescence test is carried out in advance to check cleanability.

The isolator is controlled via touchscreen using an intuitively structured user interface. All processes can also be controlled and monitored via visualizations.

Connections in the inner chamber of the isolator are operated via a touch panel
Cleaning in the work area is carried out by a wash- in- place (WIP) or cleaning- in- place (CIP) process
AP water connection for a WIP or CIP system for chamber cleaning

Maximum Safety for Personnel

Safe working conditions according to GMP Class B

Containment isolators from Ortner prevent the release of hazardous substances- for example, during the production of solid-based medications, where powder particles could be carried away by the air.

Cleanability Test

The cleaning of the work area is done by a WIP or CIP process
The cleanability is confirmed with a fluorescence test
Riboflavin is used to test cleanability
Ortner Plus Symbolgrafik

Ortner PLUS

  • Automated leak test
  • Automated, validated WIP process with rotary and fogging nozzles
  • Dehumidifier for the drying phase after the WIP process
  • Low noise level of < 60 dB (A)
  • Plug & Play system

Environmental Monitoring

Monitoring plays an heavy 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: 

Speed of the Laminar
Laminar flow velocity | Pressure | Temperature | Humidity

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 particle monitoring, vacuum cleaner, compressed air or scales, etc.

Technical Data

Overall Data of the Containment 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
AP water 4 - 65 °C, min. 4 bar, 33 l / min
Exhaust air/supply air: 110 to 260 m³/h (parameterizable)

Technical Data

Control and Monitoring

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

Isolator Chamber (workspace)

Clean room class in the isolator chamber: ISO 7
Front pane glass type/ sealing system: ESG 15 mm/ dynamic
Tightness class of the isolator chamber according to ISO EN 14644-7: 3
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)
Protection filter circulating air: HEPA H14
Chamber cleaning nozzle for AP water

Technical Data

Isolator Supply Air Module

Ventilation principle: turbulent mixed ventilation
Mainfilter stage: HEPA H14

Degree of Protection

Primary: Personal & environmental protection
Secondary: Product protection

Technical Data

Lock

Air pressure in the airlock (SET): -10 to -100 Pa (parameterizable)
Protectionfilter 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

Cleaning- WIP or CIP process

Manual: Hand shower
Automatic: Rotating nozzles
Washing media: AP water cold/ warm, chemical via WIP kitchen

Weitere Informationen

Additional Options

  • Material lock right/ left with fully automatic bio- decontamination
  • Isolator height adjustable
  • Shelf system 150 mm deep
  • Additional sliding tray

Additional Options

  • Integrated temperature and humidity monitoring
  • Intercom system with surveillance camera
  • Remote maintenance access
  • Audit trail
  • OPC- DA client coupling to the operator's higher- level system

Additional Options

  • RTP port
  • RTP beta port endless liner
  • Outer coated
  • ICH9 risk assessment and GMP qualification IQ/ OQ
  • GAMP5 computer validation

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