IRM SDE115 Dry Heat Sterilizer
| Brand | IRM |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | SDE115 |
| Convection Type | Forced Air Convection |
| Temperature Range | Ambient + 5 °C to 300 °C |
| Temperature Control Accuracy | ±0.2 °C |
| Temperature Uniformity | ±2% |
| Heating Power | 1000 W |
| Internal Dimensions (W×D×H) | 500 mm × 450 mm × 510 mm |
Overview
The IRM SDE115 Dry Heat Sterilizer is a precision-engineered laboratory-grade thermal sterilization system designed for reliable, repeatable destruction of microorganisms—including bacterial endospores—via sustained elevated temperature in an oxygen-rich environment. Unlike moist-heat methods (e.g., autoclaving), dry heat sterilization relies on conductive and convective heat transfer to achieve microbial lethality through protein denaturation and oxidative damage. This mechanism makes the SDE115 especially suitable for heat-stable, moisture-sensitive, or non-porous materials such as glassware, metal instruments, powders, oils, and anhydrous pharmaceutical excipients. Its forced-air convection architecture ensures rapid thermal equilibration and minimizes temperature gradients across the chamber, supporting compliance with ISO 17665-1, ISO 11138-4, and USP requirements for dry heat sterilization validation.
Key Features
- Forced-air circulation system with adjustable fan speed for optimized airflow distribution and reduced thermal overshoot during ramp-up.
- High-resolution LCD touchscreen interface with intuitive navigation, real-time display of setpoint/actual temperature, elapsed time, remaining time, segment progress, cycle count, and date/time stamp.
- Dual-zone PID control architecture with auto-tuning capability—configurable low- and high-temperature PID parameters to maintain stability across wide operational ranges (ambient + 5 °C to 300 °C).
- Temperature correction function enables user-defined offset calibration to compensate for sensor drift or chamber-specific thermal lag.
- Comprehensive safety redundancy: integrated leakage current circuit breaker, independent mechanical overtemperature cut-off (non-resettable at >320 °C), door interlock switch (heating disabled upon door opening), and built-in controller-based overtemperature alarm.
- Programmable operation modes: constant-temperature hold, timed sterilization, delayed start (预约运行), and multi-segment ramp-soak profiles (up to 50 segments, 99 cycles, infinite loop option).
- U-disk data logging: continuous recording of temperature vs. time with timestamp; exportable CSV files for audit-ready documentation and statistical process analysis.
- Power-fail recovery: automatic resumption from last active segment upon power restoration, preserving process integrity during brief outages.
Sample Compatibility & Compliance
The SDE115 accommodates standard laboratory glassware (e.g., Petri dishes, pipettes, flasks), stainless-steel tools, ceramic components, and thermally stable polymers. Its internal volume (115 L) and shelf configuration (2 standard + 4 optional shelves, each rated for 30 kg load) support batch processing under GLP/GMP-aligned workflows. Chamber uniformity (±2%) and stability (±0.2 °C) meet minimum performance criteria specified in ISO 13408-2 for dry heat sterilizers used in pharmaceutical manufacturing. Optional temperature data loggers (validated per ASTM E2810) and printer modules enable full traceability required for FDA 21 CFR Part 11-compliant environments.
Software & Data Management
The embedded microcontroller firmware supports secure parameter management via password-protected screen lock (user-definable 4–6 digit code). All operational events—including mode changes, setpoint adjustments, door openings, alarms, and power interruptions—are logged with timestamps in non-volatile memory. U-disk export includes raw temperature readings at configurable intervals (1–60 sec), enabling post-run analysis using third-party software (e.g., Excel, JMP, MATLAB). The system does not require external PC connectivity for basic operation but supports optional RS485 communication for integration into centralized lab monitoring platforms.
Applications
- Sterilization of reusable surgical instruments and dental burs where steam penetration is impractical.
- Depyrogenation of glass vials and ampoules prior to aseptic filling in parenteral manufacturing.
- Decontamination of laboratory ovens, weighing boats, and filtration apparatus exposed to biological hazards.
- Thermal validation studies for sterilization cycle development and requalification per ISO 11138-4 Annex B.
- Pre-baking of quartz cuvettes and optical components to remove organic residues without hydrolysis risk.
- Accelerated aging tests for packaging materials under controlled thermal stress conditions.
FAQ
What is the maximum validated sterilization temperature for the SDE115?
The unit is rated for continuous operation up to 300 °C, with thermal validation typically performed at 160 °C for 2 hours or 180 °C for 30 minutes per ISO 11138-4.
Can the SDE115 be used for depyrogenation?
Yes—its temperature uniformity and stability at ≥250 °C satisfy USP criteria for pyrogen removal from glassware and metallic devices.
Is the temperature uniformity verified across the entire chamber volume?
Uniformity testing per ISO 13408-2 requires ≥9 thermocouples placed at defined geometric locations; results must demonstrate ≤±2% deviation from setpoint at all points during steady-state operation.
Does the system support IQ/OQ protocol execution?
Standard factory documentation includes calibration certificates for temperature sensors and electrical safety reports; optional IQ/OQ templates are available upon request for GMP-regulated facilities.
How is data integrity ensured during long-duration cycles?
All recorded data reside in write-protected flash memory; U-disk exports are checksum-verified and include metadata (operator ID, cycle ID, instrument serial number) to fulfill ALCOA+ principles.
