Modular Gmp isolator for aseptic processing

Ensure contamination-free production with this modular aseptic isolator, designed for sterile handling and bio-decontamination, enabling precise process control and seamless integration into your sterile production line.

Maintains Sterility and Controls Contamination

The ISOFLEX Modular Aseptic GMP Isolator from Getinge is engineered to provide a robust solution for aseptic processing and contamination control in biopharmaceutical and pharmaceutical manufacturing. This isolator stands out with its modular design, allowing customization to fit specific process needs, including sterility testing, bio-decontamination, and repacking. Utilizing engineered turbulent flow or unidirectional airflow, it ensures precise environmental control, meeting Grade A/ISO 4.8 standards necessary for handling sterile APIs or personalized medicines.

The ISOFLEX efficiently supports high-throughput operations, integrating seamlessly into existing production lines with its PLC-based control system from Siemens or Allen Bradley. This system offers user-friendly interfaces for intuitive process monitoring and parameter adjustments. Energy efficiency is enhanced by focusing control within the isolator environment, reducing consumption compared to traditional cleanrooms.

Tailored for various applications, it finds use in producing monoclonal antibodies, insulin analogs, TPN admixtures, and more. The isolator is fully compliant with FDA 21 CFR Part 11 and GMP Annex 11, ensuring adherence to stringent regulatory standards. Optional features like bio-decontamination hatches and adaptable PLC systems underscore its capability to evolve with technological and process requirements, backed by engineering support for unique configurations.

Benefits

  • Ensures high sterility and contamination control with precise environmental management.
  • Customizable modular design accommodates future process changes and expansions.
  • Reduces energy use by limiting controlled environments to the isolator, lowering operational costs.
  • Compliant with FDA and GMP standards, supporting regulatory approval processes.
  • Enhances productivity with seamless integration into existing production lines, minimizing downtime.

General


Applications
Total parenteral nutrition (tpn),Personalized medicine,Cell,Sterile apis,Biopharmaceuticals,Gene therapy,Cytotoxic reconstitution,Intravenous (iv) solution
End products
Tpn admixtures,Erythropoietin,Paclitaxel,Individualized cancer vaccines,Monoclonal antibodies,Car-t cell products,Adeno-associated virus vectors,Docetaxel,Insulin analogs,Chemotherapy admixture,Iv saline solution
Steps before
Parts preparation,Transfer of sterile components,Cell culture preparation
Steps after
Sterility Testing,Bio-decontamination,Repacking of sterile components
Input ingredients
sterile components,closures,H2O2,HEPA filters
Output ingredients
sterile products,contamination-free components,batch reports
Market info
Getinge is known for providing innovative healthcare and life sciences products, specializing in medical technology, infection control, surgical workflows, and critical care solutions. They maintain a strong reputation for quality and technological advancement in these sectors.

Technical Specifications


Automation
Siemens or Allen Bradley PLC-controlled
Ventilation
Engineered Turbulent Flow (ETF) / Unidirectional Airflow (UDAF)
Airflow control
HEPA filters
Compliance
FDA 21 CFR Part 11 / GMP Annex 11
Interface
19" color touch panel PC
Bio-decontamination
Integrated H2O2 generator
Data Storage
Local or network storage

Operating Characteristics


Modular design
Yes
Automation level
PLC / SCADA
Batch vs. continuous operation
Batch
Airflow type
Engineered Turbulent Flow / Unidirectional Airflow
Bio-decontamination method
H₂O₂ generator
Traceability
Built-in SCADA / FDA 21 CFR Part 11 compliant

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Modular design
Yes
Footprint size
Customizable
Glove configuration
Three-glove or four-glove versions
Front window accessibility
Large,easily opened
Bio-decontamination airlocks
Configurable at one or both ends
HMI positioning
Left or right side

Custom Options


Control Panel Type
19” color touch panel PC
HMI Positioning
Left or right side
Glove Ports
Three-glove or four-glove versions
Loading Window
Large front window,easily opened
Airflow Type
Turbulent or unidirectional airflow
Integration with Transfer Solutions
Compatible with DPTE® Transfer Solutions
Bio-decontamination Airlocks
Can be added at one or both ends
Process Control System
Siemens or Allen Bradley PLC
Modular Design
Flexible configuration and modification