Cost-effective rigid-wall isolator with a focused core feature set that maximizes value
- 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.
Simple and clean design
Simple and clean design
Meet various aseptic process requirements with Unidirectional Airflow (UDAF) or Engineered Turbulent Flow (ETF) ventilation.Read more
User-friendly Siemens HMI providing connectivity and traceability.Read more
Safe and easy access to the chamber and hatch thanks to their door opening upwards.Read more
Effective bio-decontamination with Steritrace, a built-in bio-decontamination unit.Read more
Ensure safe production and process control with a reliable, repeatable, traceable leak detection system that enables seamless in-situ glove testing.Read more
A dual-waste DPTE-BetaBag® allows for safe removal of liquid and solid waste from the isolator.Read more
Easy to access
Intelligently designed for simple, direct, operator-friendly access.
One of the unique features of ISOPRIME is the upwards-opening door to its optional transfer hatch and main chamber.
This frees up working space in front of the isolator for operators to easily load or unload material and interact with the control panel when the door is open.
Safe and efficient waste handling
A dual-waste DPTE-BetaBag® allows for safe removal of liquid and solid waste from the isolator.
The DPTE® system provides egress from inside the isolator chamber while maintaining isolator integrity; there is no risk of sample or environmental contamination.
Easy in-house maintenance
Save time and effort during maintenance with direct and easy access to the electrical cabinet. Save space by reducing the clearance area for maintenance by using the ISOPRIME front, right, and top accesses.
At Getinge, we offer comprehensive support whenever you need it. An optional integrated module allows Getinge’s team to safely execute software updates and investigations remotely.
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.
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
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.
The ISOPRIME is a multipurpose and tailored solution used in various aseptic applications.
- Sterility testing or quality control (membrane filtration, direct inoculation, rapid method)
- Small batch fill and finish
- Transfer or Biodecontamination isolator (can be mobile)
- Aseptic processing (assembly of processes, parts preparation, etc.)
- Transfer, repacking of sterile components, closures, etc.
- Reactor or vessel charging isolator
- Assembly, preparation of medical devices
- Compounding (Total Parenteral Nutrition TPN, Intravenous IV solution, cytotoxic reconstitution…)
- Cell culture, cell & gene therapy
- Personalized medicine