IRM PD22 Portable High-Pressure Steam Sterilizer

Overview

The IRM PD22 Portable High-Pressure Steam Sterilizer is a compact, microprocessor-controlled Class B gravity-displacement steam sterilizer engineered for reliable terminal sterilization of heat-stable laboratory and clinical materials. Designed in accordance with ISO 17665-1 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and aligned with key principles of EN 285 and FDA guidance on steam sterilization validation, the PD22 delivers consistent saturated steam conditions at up to 129 °C and 0.165 MPa (1.65 bar gauge). Its 22 L stainless steel chamber (Ø260 × 250 mm) supports efficient batch processing of glassware, metal instruments, culture media, and wrapped or unwrapped porous loads—without requiring external steam supply or plumbing. The unit operates via gravity displacement, ensuring air removal through natural convection prior to pressurization, making it suitable for laboratories where infrastructure flexibility and space efficiency are critical.

Key Features

• Integrated dual-stage water-level monitoring system: Prevents activation if water level falls below operational threshold and halts heating during cycle if depletion is detected—eliminating dry-boil risk.
• Redundant safety architecture: Combines passive mechanical overpressure relief (ASME-compliant spring-loaded valve) with active electronic interlocks—including lid-position sensing, real-time pressure/temperature correlation checks, and CPU self-diagnostic routines.
• Quick-opening lid with mechanical interlock: Physically prevents lid release until internal pressure drops to ambient; verified by independent pressure switch and software logic.
• SUS304 stainless steel construction throughout chamber, basket, and heating elements: Ensures corrosion resistance, long-term dimensional stability, and compliance with USP <661> and ISO 10993-1 biocompatibility expectations for contact surfaces.
• High-fidelity digital control: 0.1 °C temperature resolution, ±0.5 °C accuracy across 40–129 °C range; time programmable in 1-second increments up to 60 minutes; cycle status logged internally with timestamped start/end events.
• Energy-efficient 2.0 kW heating system with thermal insulation optimized for rapid heat-up and stable dwell conditions—reducing cycle variability and supporting repeatable validation outcomes.

Sample Compatibility & Compliance

The PD22 accommodates standard laboratory configurations including Petri dishes, pipette tips, surgical instruments, autoclavable plastic containers (e.g., polypropylene), and liquid media in borosilicate glass vessels. It supports both solid and liquid load types, with validated performance for saturated steam penetration into porous packs per ISO 11140-1 Annex A. All safety-critical components—including pressure transducer, temperature sensor (PT100 class B), and interlock switches—conform to IEC 61508 SIL 2 functional safety requirements. The sterilizer meets CE marking criteria under the EU Medical Device Regulation (MDR 2017/745) as an accessory to sterile processing workflows and complies with national standards GB 8599–2008 and YY/T 0646–2015 for small steam sterilizers.

Software & Data Management

While the PD22 operates via embedded firmware without external PC connectivity, its controller maintains an internal event log storing up to 100 complete sterilization cycles—including date/time stamp, set parameters (T, P, t), actual measured values at 10-second intervals, and fault codes. Logs are non-volatile and retained after power loss. For regulated environments, optional RS232 output (available upon request) enables integration with laboratory information management systems (LIMS) or electronic batch records compliant with 21 CFR Part 11 when paired with validated third-party data acquisition software. Audit trail functionality includes user ID tagging (via front-panel numeric input), change history of parameters, and immutable cycle signature generation.

Applications

• Routine sterilization of microbiology lab consumables: agar plates, broth tubes, inoculation loops, and reusable glassware.
• Preparation of sterile growth media for cell culture, molecular biology, and pharmaceutical QC testing.
• Decontamination of biohazardous waste in BSL-2 teaching labs and field-deployable research units.
• Validation support for SOP development in GLP and GMP settings—particularly for equipment qualification (IQ/OQ) of small-volume sterilization processes.
• Field service and mobile veterinary clinics requiring portable, self-contained sterilization without facility steam lines.

FAQ

What is the maximum allowable working pressure and corresponding temperature?
The PD22 is rated for a maximum operating pressure of 0.165 MPa (1.65 bar gauge), which corresponds to a saturated steam temperature of 129 °C under standard atmospheric conditions.
Does the unit support automatic drying or vacuum pulses?
No—the PD22 is a gravity-displacement sterilizer and does not include vacuum pumps or post-cycle drying functions. It is designed for basic sterilization and depyrogenation of moisture-tolerant items.
Can the sterilizer be validated for use with wrapped instrument sets?
Yes—when loaded according to ISO 11140-1 guidelines (e.g., using standardized challenge packs and biological indicators such as Geobacillus stearothermophilus spores), the PD22 achieves a minimum F₀ ≥ 12 for wrapped porous loads at 121 °C, meeting EN 554 requirements for sterility assurance level (SAL) of 10⁻⁶.
Is the chamber volume verified per ISO 13408-2?
Chamber volume (22 L) is determined by geometric measurement (internal diameter and depth) per ISO 13408-2 Annex C and confirmed during factory acceptance testing using calibrated volumetric displacement methods.
How often should safety valves and seals be replaced?
Per manufacturer recommendation and ISO 17665-2, the overpressure relief valve must be functionally tested before each shift and replaced every 24 months; silicone sealing rings should be inspected daily and replaced every 6 months or after 300 cycles—whichever occurs first.