Setting the New Standard for Aseptic Processing: Esco OxAP Isolator
Esco Lifesciences introduces the Esco OxAP (Operational Excellence Aseptic Platform) Isolator, its latest innovation in isolator technology, purpose-built to meet the stringent requirements of aseptic processing and sterile product handling.
Pharmaceutical isolators are widely recognized under PIC/S, TGA, and USP guidelines as recommended primary engineering control to minimize operator contact with aseptic materials that are highly sensitive and vulnerable to cross-contamination. The OxAP is engineered to meet these expectations with the precision, reliability, and safety that critical aseptic operations demand.
The platform operates under positive pressure with Grade A (ISO 5) unidirectional airflow in its main chamber, backed by a heavy-gauge 3.0 mm SS316L work chamber and a Class 3 pressure-hold rating per ISO 10648-2 for verified containment integrity. Its four-glove main chamber, paired with a non-gloved transfer chamber, enables efficient operator access and material transfer, while nebulized H2O2 bio-decontamination achieving a 6-log reduction — supported by catalytic converters on every chamber exhaust and the recirculation loop - minimizes operator and environmental exposure.
A 15-inch Allen-Bradley HMI/PLC with standard relay contact for facility integration rounds out a platform suited to applications ranging from aseptic filling to sterility testing as a critical go/no-go test for batch release. Esco's standard options and configurations ensure that the OxAP can be tailored to specific process and facility requirements.
Applications
- Aseptic Processing
- Aseptic Filling
- Cell Processing
- Sterility Testing
- Material Transfer
Key Features & Benefits
- 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
- HEPA (H14) Filtration on supply and exhaust, protecting both the aseptic environment and the surrounding room
- 15" Allen Bradley HMI/PLC 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 performed in accordance with ISO 14644-7, with a Class 3 rating per ISO 10648-2
- Inflatable Door Seals on all doors for a reliable aseptic boundary
- Bag-Out Port with SART and RTP integration for aseptic material transfer
- Optional Wireless Glove Leak Tester for integrated glove integrity testing
- Data Logging and PDF Reporting for full process traceability
The OxST Variant
Also available is the OxST, a purpose-built sterility testing variant of the OxAP. It shares the same chamber construction, airflow design, and aseptic performance as the standard platform, differing only through the addition of an integrated sterility test pump, a floor-level drain, and a cable pass-through for foot-pedal operation. These modifications have minimal impact on the unit's footprint or aseptic integrity.
As part of Esco's comprehensive aseptic containment and cleanroom equipment portfolio, the Esco OxAP Isolator supports pharmaceutical manufacturers and testing laboratories in meeting the highest standards of sterility assurance and regulatory compliance.
