Sterility testing isolator for pharmaceutical labs
Ensure reliable sterility testing in a controlled sterile environment with this isolator, designed to optimize workflows, minimize contamination risks, and facilitate dual-operator continuous processing for efficient pharmaceutical and medical device production.
Facilitates Sterility Testing and Bio-Decontamination
The ISOTEST Sterility Testing Isolator from Getinge is engineered for precise sterility testing and bio-decontamination in pharmaceutical and biotechnological operations. This two-person isolator optimizes workflows, enabling continuous operations with dual-operator access. Designed to support diverse applications such as aseptic processing, cell culture, and gene therapy, it facilitates the production of sterile vials, pre-filled syringes, and more.
The isolator integrates a single Siemens PLC control system for process monitoring and offers SCADA integration, enhancing control and traceability. It boasts a high throughput of up to 40 tests per 8-hour shift with rapid bio-decontamination cycles using hydrogen peroxide vapor (HPV). The DPTE-BetaBag® system ensures safe waste handling without compromising isolator integrity. Its design meets industry standards for sterile environments, making it ideal for healthcare facilities, pharmaceutical manufacturers, and research labs.
Benefits
- Increases operational efficiency by enabling continuous testing with dual-operator access.
- Enhances contamination control, reducing false positives and ensuring reliable sterility results.
- Maximizes productivity with bio-decontamination cycles completed in 30-45 minutes.
- Ensures process integrity and traceability with integrated PLC controls and SCADA compatibility.
- Provides safe waste management, maintaining sterile conditions and isolator integrity.
- Applications
- Total parenteral nutrition (tpn), Personalized medicine, Aseptic processing, Medical devices, Sterile closures, Cell, Sterile drugs, Gene therapy, Intravenous (iv) solutions, Sterile components, Cytotoxic reconstitution, Pharmaceuticals
- End products
- Implantable medical devices, Car-t cell therapies, Biopharmaceutical products, Cytotoxic drug formulations, Sterile surgical instruments, Sterile stoppers, Sterile caps, Monoclonal antibodies, Personalized cancer treatment formulations, Chemotherapy drugs, Pre-filled syringes, Mrna vaccines, Sterile vials, Intravenous vitamin blends, Total parenteral nutrition bags, Custom sterile kits
- Steps before
- Aseptic processing, Parts preparation, Transfer of sterile components, Repacking of sterile components, Reactor or vessel charging, Assembly and preparation of medical devices, Compounding
- Steps after
- Bio-decontamination, Traceability reporting, Safe waste handling, Testing result analysis, Continuous workflow monitoring
- Input ingredients
- sterile drugs, sterile components, sterile devices, 20 ml containers, 20 ml vials
- Output ingredients
- reliable sterility test results, bio-decontaminated components, validated process data, waste removal, safe waste
- 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.
- Bio-decontamination cycle time
- 30-45 minutes
- Throughput rate
- Up to 40 tests per 8-hour shift
- Automation
- PLC-controlled
- Sterilant used
- Hydrogen peroxide (H2O2) vapor
- Dual-operator capacity
- Yes
- Closed system design
- Yes
- Process monitoring and control
- Siemens PLC system
- Data integration option
- SCADA integration
- HMI type
- Color touchscreen
- Batch vs. continuous operation
- Continuous
- Automation level
- PLC / SCADA
- Cleaning method
- HPV Bio-decontamination
- Changeover time
- 30-45 minutes
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Workstation configuration
- Double work station
- Operator access
- Dual-operator access
- Control panel type
- Color touchscreen
- Integration system
- Siemens PLC control system
- Decontamination system
- Integrated bio-decontamination unit using H2O2 vapor
- Waste handling system
- Dual-waste DPTE-BetaBag®
- Control panel type
- Color touchscreen
- Integration possibilities
- SCADA, Remote PC
- Waste handling system
- DPTE-BetaBag®