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