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Cytostatic Isolators

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.

Hermetically sealed system with glove- sleeve system as access device
Easy operation and accessibility of control and monitoring system
Personal and product protection is achieved through a solid physical barrier

Highest Safety for Personnel and Environment

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.

Closed System for Highly Toxic Processes

Before each H2O2 decontamination, the leak test is performed
All processes are monitored and controlled via touch panel
Loading and unloading of the isolator takes place via a transfer lock with automatic sliding doors
Ortner Plus Symbolgrafik

Ortner PLUS

  • Fully integrated glove and isolator leak test according to ISO 14644- 7
  • Touch panel for operation and monitoring of the process
  • Fully automatic LOG6 H2O2 decontamination with logging
  • Integrated H2O2 gas generator for stable decontamination processes
  • H2O2 fast- acting airlocks for inward and outward transfer of materials
  • Electrically height- adjustable seat/ standing workstation (+/- 150 mm)
  • Low noise level of < 58 dB (A)
  • Plug & Play system

Ergonomics

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

Interior Chamber Equipment

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

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

Bio- Decontamination with H2O2

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.

Quick Lock for Loading and Unloading

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 Data

Overall Data of the Cytostatic 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 Data

Degree of Protection

Primary: Personal & Environmental Protection
Secondary: Product protection

Isolator Chamber (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: 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).
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)
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

Technical Data

H2O2 Decontamination

Isolator ready for H2O2 decontamination
Decontamination level: LOG 6 reduction

Integrierter 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

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.

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

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
  • ICH9 risk assessment and GMP qualification IQ/ OQ
  • GAMP5 computer validation

Fully Automatic Bio- Decontamination

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.