Sterility Testing
Isolators
Engineered for Excellence. Purpose-built for cGMP sterility testing with robust protection for products and operators. Trusted by the FDA.
Engineered for Excellence
ISOFLOW’s sterility testing isolators are purpose-built for cGMP sterility testing, offering robust protection for both products and operators. Available in two configurations, these systems cater to a range of testing needs.
C8 Model (8′ with 4 Gloves)
Designed for high-volume sterility testing, featuring four glove ports for multi-operator use and maximum throughput.
C4 Model (4′ with 2 Gloves)
A compact, mobile option ideal for smaller batches or material transfer, providing flexibility in dynamic workflows.
Technical Specifications
- ISO 5 Unidirectional Airflow Vertical laminar flow (60 ft/min @ 12″) in positive pressure maintains a sterile environment.
- 316 Stainless Steel Construction Combined with tempered glass for durability and visibility.
- Integrated H2O2 Decontamination Fast cycles and recovery rates. One HMI controls both the isolator and generator.
- Millipore Pump Integration Seamlessly integrates sterility pumps for efficient testing workflows.
Intelligent Monitoring & Control
Isotech Pharma isolators integrate cutting-edge technology for seamless operation and real-time oversight of your critical environment.
HMI Touch Interface
Allen-Bradley HMI provides comprehensive control, including pressure adjustment, temperature/humidity monitoring, door status, and out-of-range alarms.
Magnetic Gauges
Continuous pressure monitoring for each fan filter unit and the main chamber ensures optimal conditions are met at all times.
Lighting System
Lighting installed on both sides of the chamber, positioned over each door with individual/overall switches for maximum visibility.
Why Isotech Pharma?
Regulatory Compliance
Meets IEST, FDA, and EU GMP Grade A standards for aseptic processing.
Enhanced Safety
Automatic interlocking doors and positive pressure design minimize contamination risks.
End-to-End Support
From design to validation (IQ/OQ/PQ), we’re your partner in compliance.
Elevate Your Operations
Discover how Isotech Pharma’s sterility testing solutions can ensure compliance and efficiency.
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