Product Description
The ISOCARE Sterility Testing Isolator by IWT combines EU-GMP Class A (ISO 5) compliance with Italian engineering excellence to deliver a compact, high-performance solution for sterility testing. Designed with a modular, plug & play setup and predefined configurations, it ensures fast installation and seamless integration into existing workflows. Its automatic decontamination system achieves ultra-rapid 6-log microbial reduction, minimizing downtime while enhancing safety for both operators and products. Energy-efficient and space-saving, ISOCARE is equipped with an advanced control system for real-time monitoring and reliable performance in aseptic and aseptic-toxic environments.
Main Features and Benefits
- EU-GMP Class A (ISO 5) Compliance
- Automatic Decontamination
- Modular, Plug & Play Design
- Compact and Sustainable with Enhanced Safety
- Ensures the highest level of product and operator protection for aseptic and aseptic-toxic operations
- Integrates cGMP standards and Quality by Design (QbD) principles to elevate operational performance
- EU-GMP Class D environments, reducing operational and energy costs
- SCADA system integrates with MES through UPC UA, complying with 21 CFR Part 11 and GAMP5 standards for seamless process control
