Rigid-Wall Isolator For Common Aseptic Applications

Cost-effective rigid-wall isolator with a focused core feature set that maximizes value

• Operator-friendly

• Full traceability and compliant with FDA 21 CFR Part 11

• Core high-end Getinge isolator capabilities in a cost-effective solution

• Optimized for continuous operations

Easy access to electrical cabinet for maintenance operations Versatile, the ISOPRIME is suitable for all major sterile applications from aseptic filling and repackaging of sterile components, to sterility testing, compounding, preparation of medical drugs and devices, and more.

Our isolators are compatible with our full range of DPTE® transfer solutions to ensure safe and efficient transfer without breaking containment.

Efficient ventilation

With the ISOPRIME, choose from unidirectional or turbulent airflow to meet various process requirements.

In this sealed, operator-free environment with control over sources for contamination entry (HEPA filters, transfer ports), engineered turbulent flow (ETF) is sufficient to maintain sterile conditions.

However, for aseptic applications where it is important to ensure that nonviable particles are rapidly swept away from critical areas, unidirectional airflow (also known as UDAF, LAF, laminar flow) is appropriate to meet Grade A/ISO 4.8.

Validated process control and traceability

ISOPRIME offers a Siemens PLC for process control and monitoring. The control system is equipped with a 10" color touch panel PC with an intuitive user interface for easy navigation, operation, and parameter monitoring. The reports are generated in PDF and can be transferred to a network server, a USB flash drive, or sent to a network printer.

User access is easily managed and adapted to your needs using a non-pyramidal structure. Authorized users can adjust process parameters according to the unique requirements of a specific process. The system allows you to choose up to two signatories.

ISOPRIME is FDA 21 CFR Part 11 compliant in accordance with the PLC capabilities.

Modular design

The modular design allows the isolator to be tailored according to your needs with the choice of:

• UDAF or ETF ventilation
• Optional bio-decontamination transfer hatch
• Customizable, retrofittable secondary access service plate
• Integrated monitoring devices, shelving solutions and other typical isolator accessories

Effective bio-decontamination

When it comes to bio-decontamination, the ISOPRIME provides the means to bio-decontaminate the isolator working chamber, the hatch, or both chamber and hatch simultaneously.

The integrated H₂O₂ generator ensures safe operations and reliable processes. The unit is controlled by the same interface as the isolator, thus enabling validation and maintenance of a single piece of equipment. The H₂O₂ bottle is fitted with an RFID (Radio Frequency Identification Device) to improve and ensure traceability, quality, and batch number management.