Cost-effective rigid-wall isolator for aseptic applications
Ensure sterility and safety with a versatile isolation and decontamination solution designed for continuous operations and seamless integration in aseptic processes.
Ensures Sterility and Safe Aseptic Processing
The ISOPRIME Isolators from Getinge provide a robust solution for pharmaceutical, biotech, and healthcare facilities requiring stringent sterility and contamination control. Designed with modular rigid-wall systems, the ISOPRIME excels in a range of aseptic and sterile processing applications, including compounding, aseptic filling, and sterility testing. Engineered for continuous operation, these isolators incorporate a validated Siemens PLC for reliable process control and traceability while supporting large-scale production efficiency through versatile airflow options—unidirectional or turbulent.
Suited for a diverse array of end-products like monoclonal antibodies, saline IV bags, and personalized cancer vaccines, ISOPRIME ensures compliance with FDA 21 CFR Part 11. It delivers comprehensive bio-decontamination capabilities through an integrated H2O2 generator, facilitating in-situ cleanliness and safety.
Optimized for ease of access and maintenance, the design features upward-opening doors and convenient electrical cabinet entry points, reducing downtime. Integration with Getinge’s DPTE® transfer system guarantees secure material transfer without breaking containment, while glove leak testing technology ensures operational integrity.
Constructed for resilience, ISOPRIME offers various customization options, including specific ventilation and access configurations, tailored to meet unique production line needs. It supports both liquid and solid product types, making it adaptable across laboratories and processing departments dedicated to cutting-edge medical solutions.
Benefits
- Enhances production efficiency with continuous, uninterrupted aseptic processing.
- Lowers operational costs through integrated bio-decontamination and streamlined maintenance.
- Ensures regulatory compliance with FDA 21 CFR Part 11 standards for traceability and control.
- Facilitates safe and secure material transfer, preventing contamination risks.
- Customizable design supports a wide range of applications and industry-specific requirements.
- Applications
- Closure components,Personalized medicine,Medical devices,Cell,Biopharmaceuticals,Gene therapy,Total parenteral nutrition,Intravenous solutions,Sterile components,Cytotoxic reconstitution,Pharmaceuticals
- End products
- Gene-edited skin grafts,Insulin vials,Capsules,Lipid emulsion tpn mixtures,Personalized cancer vaccines,Sterile syringes,Vial stoppers,Monoclonal antibodies,Car-t cells,Pacemakers,Saline iv bags,Tablets,Chemotherapy iv mixtures,Surgical stents
- Steps before
- Aseptic filling,Component preparation,Material loading
- Steps after
- Sterility testing,Compounding,Medical device preparation,Repackaging,Waste handling
- Input ingredients
- aseptic components,sterile components,medical drugs,raw materials,H2O2 for decontamination,cell cultures,parts for assembly
- Output ingredients
- finished sterile products,compounded medications,sterile medical devices,tested sterility samples,prepared cell and gene therapy solutions
- 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
- PLC-controlled
- Compliance
- FDA 21 CFR Part 11
- Ventilation Type
- Unidirectional Airflow (UDAF) / Engineered Turbulent Flow (ETF)
- Access Mechanism
- Upwards-opening door
- Bio-decontamination
- H2O2 generator
- Glove Leak Testing
- In-situ testing system
- Waste Handling
- DPTE-BetaBag® dual-waste system
- User Interface
- 10" color touch panel
- Traceability
- Integrated with Siemens HMI
- Remote Maintenance
- Optional integrated module
- Airflow Control
- Maintain Grade A/ISO 4.8 conditions
- Working Mechanism
- Modular rigid-wall isolator
- Automation level
- PLC-controlled
- Cleaning Method
- Integrated bio-decontamination unit
- Batch vs. Continuous Operation
- Continuous
- Integrated Steps
- Bio-decontamination,Glove Leak Testing
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- FDA compliance
- 21 CFR Part 11
- Footprint
- Compact
- Transfer Hatch Type
- Upwards-opening door
- Glove Ports
- Integrated
- Ventilation System
- UDAF or ETF
- Material Compatibility
- High-quality rigid-wall construction
- Access Points
- Front,right,top accesses
- Integrated Bio-decontamination Unit
- Steritrace
- Waste Handling System
- Dual-waste DPTE-BetaBag®
- Control panel type
- 10" color touch panel PC
- HMI type
- Siemens HMI
- Integration possibilities
- Remote software updates and investigations
- Ventilation options
- UDAF or ETF
- Bio-decontamination options
- Integrated H2O2 generator
- Secondary access service plate
- Customizable,retrofittable
- Accessory integration
- Shelving solutions,monitoring devices