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.

General


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.

Technical Specifications


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

Operating Characteristics


Batch vs. continuous operation
Continuous
Automation level
PLC / SCADA
Cleaning method
HPV Bio-decontamination
Changeover time
30-45 minutes

Material Compatibility


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

Physical Characteristics


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®

Custom Options


Control panel type
Color touchscreen
Integration possibilities
SCADA,Remote PC
Waste handling system
DPTE-BetaBag®