Cost-effective rigid-wall isolator for aseptic applications
When conducting aseptic processes such as sterile testing, small batch production, or compounding, contamination control is a critical challenge. Ensuring a sterile environment and maintaining traceable processes are essential to meet regulatory standards and prevent cross-contamination.
Enhances sterility with optimized process control
The ISOPRIME isolator by Getinge offers a cost-effective solution for various aseptic applications. Designed with a rigid-wall structure, it ensures continuous operations with a focus on traceability and compliance with FDA 21 CFR Part 11. The ISOPRIME is equipped with a Siemens HMI for user-friendly process control and monitoring. Operators benefit from easy access to the chamber and hatch due to the upwards-opening door, which frees up working space. Ventilation options include Unidirectional Airflow (UDAF) or Engineered Turbulent Flow (ETF), allowing the isolator to meet diverse aseptic process requirements. Additionally, the integrated Steritrace bio-decontamination unit ensures effective sterilization, while the dual-waste DPTE-BetaBag® system enables safe waste handling without breaking containment.
Benefits
- Ensures regulatory compliance with FDA 21 CFR Part 11
- Facilitates effective bio-decontamination with integrated Steritrace unit
- Offers flexible ventilation options to meet various aseptic requirements
- Provides easy access to the chamber and hatch for maintenance
- Enables safe waste removal with DPTE-BetaBag® system