OKEO Environmental Test Chamber for Mask Preconditioning (Temperature & Humidity Controlled Chamber)
| Brand | OKEO |
|---|---|
| Origin | Imported |
| Manufacturer Type | Authorized Distributor |
| Price | USD 2,650 (Reference Only – Final Quotation Subject to Technical Specification Review and Configuration) |
Overview
The OKEO Environmental Test Chamber for Mask Preconditioning is a precision-engineered temperature and humidity controlled chamber designed specifically to meet the stringent environmental conditioning requirements of respiratory protective equipment prior to physical and filtration performance testing. It operates on a dual-loop PID-controlled refrigeration and humidification system, enabling stable, repeatable maintenance of specified temperature (typically 23 ± 1 °C) and relative humidity (50 ± 3 % RH) conditions as mandated by international standards for mask evaluation. This chamber is not a general-purpose climatic chamber; it is calibrated and validated for compliance with the preconditioning protocols defined in GB 2626–2019 (equivalent to EN 149:2001+A1:2009), GB/T 32610–2016, and GB 2890–2009 — all of which require standardized ambient exposure for at least 24 hours before tensile strength, breathability, particle filtration efficiency (PFE), and fit testing.
Key Features
- Programmable multi-segment control: 120 user-defined programs, each supporting up to 999 operational segments (ramp/soak/humidity transition)
- Dual independent PID loops for simultaneous, decoupled regulation of temperature and relative humidity
- RS-232 serial interface compliant with Modbus RTU protocol for integration into laboratory automation systems and remote supervision via PC-based software
- Comprehensive safety architecture: dry-run protection for humidifier, over-temperature/under-temperature cut-off, over-humidity/under-humidity deviation alarm, phase-loss detection, earth leakage protection, and non-fuse circuit breakers
- Power failure recovery: retains full program memory and real-time clock for up to 6 months without external power
- User-configurable time-triggered outputs (2 channels) for synchronized activation of auxiliary devices (e.g., data loggers, exhaust interlocks)
- Calibration traceability support: built-in sensor offset adjustment and probe calibration verification mode for NIST-traceable field validation
- Operational flexibility: selectable cold-start / hot-start mode; programmable hold, jump, standby, and pause functions
Sample Compatibility & Compliance
This chamber accommodates standard test specimens per ISO 13485-aligned workflows: flat-fold and cup-style respirators (including KN95, FFP2, N95, and surgical masks), up to 20 units per cycle without compromising airflow uniformity or thermal/hygrometric homogeneity. Internal chamber volume (standard configuration: 150 L) ensures ≥90% spatial uniformity across all critical zones (per IEC 60068-3-5). The unit is supplied with factory-verified calibration certificates for both PT100 temperature sensors and capacitive RH transducers, referenced to ISO/IEC 17025-accredited metrology labs. It satisfies the preconditioning clauses of GB 2626–2019 Section 6.5–6.6 (conditioning duration, tolerance, and stabilization criteria), GB/T 32610–2016 Annex A, and GB 2890–2009 Clause 6.9 — and is routinely deployed in GLP-compliant QA laboratories conducting regulatory submissions to CNCA, NMPA, and notified bodies under MDR 2017/745.
Software & Data Management
OKEO’s proprietary ChamberLink™ PC software (Windows 10/11 compatible) provides full bidirectional communication: real-time parameter monitoring, drag-and-drop program editing, automated report generation (PDF/CSV), and audit trail logging compliant with FDA 21 CFR Part 11 requirements (electronic signatures, user access levels, immutable event history). All recorded data — including chamber setpoints, actual values, alarm timestamps, and safety interlock status — are stored with ISO 8601 timestamps and embedded checksums. Data export supports ASTM E2500-21 Annex B metadata tagging for traceability in quality management systems (QMS) such as TrackWise or Veeva Vault.
Applications
- Pre-test conditioning of particulate-filtering facepieces prior to filtration efficiency (NaCl/Oil aerosol) testing per GB 2626–2019 and ISO 16900 series
- Stabilization of medical/surgical masks before differential pressure (ΔP) measurement per GB/T 32610–2016
- Environmental equilibration of filter media samples for tensile strength and elongation testing (ASTM D5034, GB/T 3923.1)
- Long-term stability assessment of electrostatically charged melt-blown layers under controlled hygrothermal stress
- Supporting ISO 10993-12 extractables studies where polymer degradation kinetics are humidity-dependent
FAQ
Is this chamber certified to ISO 17025 or UKAS standards?
No — the chamber itself is not accredited, but its factory calibration reports are issued by an ISO/IEC 17025-accredited third-party lab. End users may perform in-house verification using NIST-traceable reference standards.
Can the chamber maintain 50 ± 1% RH continuously for 72 hours?
Yes — under nominal load (≤70% internal volume occupancy) and ambient room conditions ≤28 °C/60% RH, the system achieves ±0.8% RH stability over 72-hour periods, verified per ISO 16750-4 Annex C.
Does it support Ethernet or only RS-232?
Standard configuration includes RS-232; optional RS-485 and Ethernet (TCP/IP Modbus) modules are available upon request for integration into SCADA or MES environments.
What is the typical recalibration interval recommended?
Annual recalibration is advised; however, user-performed daily verification using certified hygrometric and thermometric references satisfies ISO/IEC 17025 clause 5.5.2 for routine use.
Is GMP documentation package available?
Yes — IQ/OQ protocols, URS templates, and 21 CFR Part 11-compliant electronic record packages are provided as optional add-ons for pharmaceutical and medical device clients.
