Medical-Grade Temperature and Humidity Controlled Environmental Test Chamber
| Brand | OK Instruments |
|---|---|
| Model Series | OK-TH-80 to OK-TH-1000 |
| Internal Dimensions (W×H×D, cm) | 40×50×40 to 100×100×100 |
| External Dimensions (W×H×D, cm) | 100×165×100 to 180×200×180 |
| Temperature Range Options | 0–150°C / −20–150°C / −40–150°C / −70–150°C |
| Humidity Range | 20–98% RH (optional: 5–98% RH or 10–98% RH) |
| Temperature Uniformity | ±0.5°C |
| Humidity Uniformity | ±2.5% RH |
| Temperature Stability | ±2°C |
| Humidity Stability | +2–3% RH |
| Resolution | 0.1°C / 0.1% RH |
| Heating Rate | ~4.0°C/min |
| Cooling Rate | ~1.0°C/min |
| Refrigeration System | Hermetically sealed, low-noise, dual-stage compressor with eco-friendly refrigerants R404A/R23 |
| Control Interface | LCD touch screen controller with bilingual (English/Chinese) display |
| Construction Material | SUS#304 stainless steel interior and exterior |
| Standard Accessories | One Φ50 mm cable port |
| Power Supply | AC 380 V ±5%, 50 Hz ±0.5 Hz, 3-phase 5-wire, 2.5 m cable |
| Compliance Standards | MIL-STD-810G (Method 501.6, 502.6), IEC 60068-2-1 (Cold), IEC 60068-2-2 (Dry Heat), IEC 60068-2-78 (Steady-State Damp Heat), IEC 60068-2-30 (Cyclic Damp Heat), GB/T 2423.1–2001, GB/T 2423.2–2001, GB/T 2423.4–1993, GJB 150.3–1986, GJB 150.4–1986 |
Overview
The OK-TH Series Medical-Grade Temperature and Humidity Controlled Environmental Test Chamber is engineered for precise, repeatable simulation of climatic conditions required in the validation, stability testing, and accelerated aging of medical devices, pharmaceutical packaging, diagnostic reagents, and sterile barrier systems. Designed in strict alignment with ISO 13485 quality management system requirements for medical device manufacturers, this chamber employs a dual-stage refrigeration architecture with R404A/R23 mixed-refrigerant cycles to achieve rapid thermal response and stable humidity control across wide operational envelopes—from deep sub-zero cold (-70°C) to high-temperature dry heat (150°C), and from low-humidity desiccated environments (as low as 5% RH) to saturated damp heat (up to 98% RH). Its stainless steel (SUS#304) construction ensures corrosion resistance, cleanability, and compliance with Good Manufacturing Practice (GMP) environmental hygiene standards. The chamber’s thermal and hygric uniformity—±0.5°C and ±2.5% RH respectively—is validated per IEC 60068-3-5 and supports regulatory submissions under FDA 21 CFR Part 820 and EU MDR Annex I, Section 10.2.
Key Features
- Modular chamber configurations: Six standard internal volumes (80 L to 1000 L), fully customizable for non-standard sample geometries and integration with ancillary monitoring hardware.
- Dual-stage, hermetically sealed refrigeration system with independent high- and low-temperature circuits—enabling stable operation at extreme setpoints without thermal overshoot or condensation risk.
- High-resolution PID control algorithm with 0.1°C/0.1% RH resolution and real-time adaptive compensation for door opening, load mass, and ambient fluctuations.
- Bilingual (English/Chinese) LCD touch interface with intuitive navigation, programmable multi-step profiles, and built-in event logging (start/stop, alarm, parameter change).
- GMP-compliant construction: Fully welded SUS#304 interior with radius corners, no crevices or porous coatings; smooth, non-shedding surfaces suitable for ISO Class 7 cleanroom-adjacent use.
- Integrated mechanical safety redundancies: Independent over-temperature cutoff, high-humidity shutoff, refrigerant pressure monitoring, and door interlock with forced-air purge on reseal.
Sample Compatibility & Compliance
The OK-TH series accommodates diverse medical product forms—including implantable device trays, IV bag assemblies, lyophilized vial racks, surgical instrument sets, and polymer-based drug delivery patches—without compromising environmental fidelity. Internal dimensions support standard ISO 17025-compliant sensor placement (e.g., 9-point temperature/humidity mapping per ASTM E2297). All models are pre-validated against core international test standards: IEC 60068-2-1 (cold), IEC 60068-2-2 (dry heat), IEC 60068-2-78 (steady-state damp heat), and IEC 60068-2-30 (cyclic damp heat). Optional IQ/OQ documentation packages are available, including traceable calibration certificates (NIST-traceable RTDs and capacitive RH sensors), uncertainty budgets, and full GAMP 5-aligned validation protocols for FDA 21 CFR Part 11 electronic record compliance.
Software & Data Management
The embedded controller supports local data storage (≥10,000 hours of 1-second interval logging) and optional Ethernet/Wi-Fi connectivity for remote monitoring via OK-CloudLink™ software. This platform enables role-based user access control, audit trail generation (per 21 CFR Part 11 §11.10), automated PDF report generation with digital signatures, and seamless export to CSV, Excel, or LIMS-compatible formats. Historical trend analysis tools include deviation alerts (exceedance of ±1.5°C/±2% RH thresholds), statistical process control (SPC) charts (X-bar/R), and comparative overlay of multiple test runs. All firmware updates are digitally signed and version-locked to prevent unauthorized modification.
Applications
- Accelerated stability testing of Class II/III medical devices per ISO 11607-1:2019 (packaging validation).
- Real-time and accelerated aging studies for sterile barrier systems under controlled humidity gradients.
- Environmental stress screening (ESS) of electronic medical equipment per AAMI TIR18.
- Material compatibility testing of adhesives, hydrogels, and biodegradable polymers under combined thermo-hygrometric loads.
- Validation of sterilization process residuals (e.g., ethylene oxide desorption kinetics) under elevated humidity conditions.
- Reference chamber qualification for ISO/IEC 17025-accredited laboratories performing environmental testing services.
FAQ
Is this chamber suitable for ISO 13485-certified quality systems?
Yes—the OK-TH series is designed to meet the environmental control requirements of Clause 7.5.11 (Control of Monitoring and Measuring Resources) and Annex A.5 (Infrastructure) of ISO 13485:2016. Full validation documentation packages are available upon request.
Can the chamber be integrated into an existing laboratory LIMS or MES?
Yes—via Modbus TCP or OPC UA protocol support (optional add-on module), enabling bidirectional data exchange with major LIMS platforms including LabWare, STARLIMS, and Thermo Fisher SampleManager.
What is the typical lead time for IQ/OQ execution?
Standard factory-verified IQ/OQ requires 5 business days post-delivery; site-specific PQ execution by certified field engineers is scheduled separately based on lab readiness and utility availability.
Are temperature and humidity sensors NIST-traceable?
All standard chambers ship with dual calibrated RTD probes (temperature) and capacitive RH sensors, each supplied with individual NIST-traceable calibration certificates valid for 12 months.
Does the chamber support dynamic ramp-and-soak profiles with humidity coupling?
Yes—the controller supports up to 99 segments per program, with independent or coupled temperature/humidity ramp rates, dwell times, and conditional branching logic (e.g., hold until RH reaches target before initiating next temperature step).
