Other Brands OK-HAST Series High-Pressure Autoclave Test Chamber

Overview

The OK-HAST Series High-Pressure Autoclave Test Chamber is an engineered environmental stress testing system designed to simulate accelerated aging conditions under controlled saturated steam, elevated temperature, and positive gauge pressure. It operates on the principle of high-pressure saturated steam exposure—commonly applied in reliability validation of medical device packaging, sterilization process development, polymer stability assessment, and accelerated moisture ingress testing per ISO 11737-1, ASTM F1980, and IEC 60068-2-13 standards. Unlike conventional steam ovens or humidity chambers, this system maintains precise thermodynamic equilibrium between temperature, pressure, and relative humidity within the chamber volume, ensuring reproducible exposure profiles critical for shelf-life prediction and package integrity verification.

Key Features

• Automated test sequence execution with start-to-finish programmability—no manual intervention required after initiation.
• Dual independent overtemperature protection circuitry: primary PID-controlled heating and secondary mechanical cut-off that triggers audible alarm and immediate power disconnection upon exceeding setpoint by >2 °C.
• PID-based digital temperature controller (LED display) with ±0.1 °C steady-state accuracy and real-time feedback loop optimization.
• Delay-start digital timer activated only when chamber reaches target temperature—eliminating premature timing errors due to thermal lag.
• Simultaneous LED readout of internal pressure (kg/cm²) and temperature (°C), enabling direct correlation of thermodynamic states during exposure.
• Integrated steam quality management: automatic purge of non-condensable gases and unsaturated vapor prior to and during test cycles to ensure ≥95 % saturation ratio.
• Self-regulating water level control system with conductive probe sensing and solenoid-driven refill—prevents test interruption caused by evaporation loss.
• Interlocked door safety mechanism: chamber remains de-energized unless door is fully latched and sealed; prevents accidental operation during loading/unloading.
• Spring-loaded pressure relief valve calibrated to activate at 4.2 kg/cm² (±0.1 kg/cm² tolerance), providing fail-safe overpressure venting aligned with ASME BPVC Section VIII requirements.
• Ergonomic ABS thermal barrier on door surface limits external surface temperature to <45 °C during full-cycle operation—compliant with EN 61000-3-2 touch-safety guidelines.
• One-piece molded silicone door gasket with Shore A 60 hardness and compression set resistance >10,000 cycles—ensures long-term sealing integrity without degradation.

Sample Compatibility & Compliance

The OK-HAST chamber accommodates a wide range of sample geometries and material classes—including Tyvek®-laminated pouches, thermoformed trays, silicone elastomer seals, polyolefin films, and stainless-steel implant carriers. Its cylindrical chamber design minimizes thermal stratification and ensures uniform steam penetration across vertically stacked samples. All models meet essential requirements for GLP-compliant accelerated aging studies, supporting audit-ready documentation for FDA 21 CFR Part 11–enabled software configurations (optional upgrade). The system is validated for use in accordance with ISO 11134 for moist heat sterilization cycle development and ASTM D4332 for conditioning plastic specimens prior to mechanical testing.

Software & Data Management

Standard configuration includes embedded firmware with onboard data logging (1-second sampling interval, 30-day buffer memory) and RS-485/Modbus RTU interface for integration into centralized LIMS or MES platforms. Optional PC-based software provides real-time graphing, deviation alerts, electronic signature support, and automated report generation compliant with 21 CFR Part 11 Annex 11 requirements—including user access control, audit trail with immutable timestamps, and encrypted data export (CSV/PDF). Calibration records, maintenance logs, and cycle validation summaries are stored separately with versioned revision history.

Applications

• Accelerated aging of sterile barrier systems per ASTM F1980 and ISO 11607-1.
• Validation of terminal sterilization parameters for Class II/III medical devices.
• Moisture permeation rate estimation for pharmaceutical blister packaging.
• Hydrolytic degradation testing of biodegradable polymers (e.g., PLA, PCL).
• Corrosion susceptibility screening of coated metallic components under cyclic steam exposure.
• Process qualification of autoclave-based depyrogenation cycles in API manufacturing.
• Reliability assessment of MEMS sensors and hermetically sealed electronics packages.

FAQ

What standards does the OK-HAST chamber comply with for medical device validation?
It supports test protocols referenced in ISO 11737-1 (microbial challenge), ASTM F1980 (accelerated aging), and IEC 60068-2-13 (damp heat, cyclic)—with optional IQ/OQ documentation packages available.
Can the chamber operate continuously for extended validation runs?
Yes—designed for unattended 72+ hour operation with redundant safety monitoring, automatic water top-up, and thermal runaway prevention architecture.
Is third-party calibration certification included with delivery?
Factory calibration certificates traceable to NIST standards are provided; UKAS-accredited field calibration services are available upon request.
How is steam saturation verified during operation?
Via continuous dew point measurement using chilled-mirror hygrometry (optional add-on) or inferred from pressure–temperature equilibrium deviation analysis per IAPWS-95 formulation.
What electrical and utility requirements must be met for installation?
Three-phase 380–415 VAC ±5 %, 50/60 Hz, with dedicated 30 A circuit breaker and GFCI protection; supply water conductivity <10 µS/cm recommended for optimal boiler longevity.