Redefining Sterility Testing | Esco OxST Isolator | Esco Lifesciences Group
Redefining Sterility Testing: Esco OxST Isolator
Esco Lifesciences introduces the Esco OxST Isolator, a purpose-built sterility testing platform engineered to meet the stringent requirements of aseptic batch release testing.
Sterility testing is a critical go/no-go checkpoint before product release. Pharmaceutical isolators are widely recognized under PIC/S, TGA, and USP guidelines as the recommended primary engineering control for this step, minimizing operator contact with sterile materials that are highly sensitive and vulnerable to cross-contamination. Built on Esco's OxAP (Operational Excellence Aseptic Platform), the OxST delivers the precision, reliability, and safety required for demanding sterility testing applications.
The platform operates under positive pressure with Grade A (ISO 5) unidirectional airflow in the main chamber. It features a heavy-gauge 3.0 mm SS316L work chamber and a Class 3 pressure-hold rating per ISO 10648-2 for verified containment integrity. The four-glove main chamber, paired with a non-gloved transfer chamber, provides efficient operator access and material transfer while maintaining the aseptic environment of the main chamber.
For bio-decontamination, the OxST utilizes nebulized hydrogen peroxide (NHP) to achieve a 6-log reduction - supported by catalytic converters on every chamber exhaust and the recirculation loop, minimizes operator and environmental exposure.
Purpose-built for sterility testing, the OxST incorporates an integrated sterility test pump, a floor-level drain, and a cable pass-through for foot pedal operation into the standard OxAP platform. These modifications are designed to support routine sterility testing workflows while maintaining a compact footprint and protecting the unit’s aseptic integrity. A 15-inch Allen Bradley HMI/PLC with standard relay contact for facility integration rounds out a platform tailored to specific process and facility requirements.
Applications
- Sterility Testing
- Aseptic Processing
- Material Transfer
- Cell Processing
Key Features & Benefits
- Integrated Sterility Test Pump - A purpose-built addition that supports sterility testing workflows without compromising the chamber's aseptic conditions
- Floor-Level Drain and Foot Pedal Cable Pass-Through - practical additions engineered for the demands of routine sterility testing
- Nebulized NHP Bio-Decontamination - Esco's Nebulized Hydrogen Peroxide (NHP) system achieves a 6-log reduction, distributing finer, more even H2O2 coverage across the chamber than atomized nozzle-based decontamination
- Comprehensive Catalytic Converter Coverage - integrated on the exhaust of all chambers and the isolator chamber's recirculation loop as standard, safeguarding both recirculated and exhausted air
- Four-Glove Main Chamber with Non-Gloved Transfer Chamber - enhanced operator reach and dexterity for aseptic processing, with material transfer that never disrupts the main chamber's aseptic environment
- Heavy-Gauge Aseptic Chamber Construction - 3.0 mm SS316L stainless steel with a fully welded, cGMP-compliant interior and rounded corners for superior cleanability
- H14 HEPA Filtration - HEPA H14 Filtration on supply and exhaust, protecting both the aseptic environment and the surrounding room
- 15" Allen-Bradley HMI/PLC – A local operating panel with standard relay contact for facility and BMS integration
- Real-time Monitoring - temperature and humidity sensors standard on all chambers, with particle monitoring and optional airflow sensor
- Automated Pressure Integrity Testing – automated testing in accordance with ISO 14644-7, with a Class 3 rating per ISO 10648-2
- Inflatable Door Seals – Integrated on all doors for a reliable aseptic boundary
- Bag-Out Port – supports SART and RTP integration for aseptic material transfer
- Optional Wireless Glove Leak Tester – enables integrated glove integrity testing
- Data Logging and PDF Reporting – supports for full process traceability and documentation
As part of Esco's comprehensive aseptic containment and cleanroom equipment portfolio, the Esco OxST Isolator gives pharmaceutical manufacturers and testing laboratories a dedicated platform for sterility assurance and regulatory compliance at batch release.
Enabling a Complete Translational Discovery to Delivery.
