PEA PEA-Series Mobile Vaporized Hydrogen Peroxide (VHP) Sterilizer

Overview

The PEA PEA-Series Mobile Vaporized Hydrogen Peroxide (VHP) Sterilizer is an engineered solution for non-thermal, residue-free biodecontamination of critical environments—including ISO Class 5–8 cleanrooms, isolators, pass-through chambers, biosafety cabinets, animal housing facilities, and HVAC ductwork. Unlike conventional steam or ethylene oxide systems, this unit employs catalytic vaporization of pharmaceutical-grade hydrogen peroxide (30–35% w/w), generating a stable, sub-micron VHP aerosol with consistent saturation kinetics. The process operates at ambient to moderately elevated temperatures (no external heating required), minimizing thermal stress on sensitive instrumentation, polymers, and electronics. Designed for compliance with international cleanroom standards—including ISO 14644-3, ISO 14644-5, and EU GMP Annex 1—the system delivers reproducible microbial inactivation through controlled vapor dispersion, real-time environmental monitoring, and catalytic decomposition post-cycle.

Key Features

• Fully automated sterilization cycles with up to 500 user-programmable protocols—each configurable for dwell time, concentration ramping, air exchange rate, and catalyst activation timing.
• Dual-stage condensation-based dehumidification ensures rapid RH reduction (<30% RH pre-cycle), enabling uniform VHP penetration and eliminating condensation risk on cold surfaces.
• Integrated Siemens S7-1200 PLC controller with audit trail functionality compliant with FDA 21 CFR Part 11 requirements—including electronic signatures, change history, and data integrity safeguards.
• Mobile chassis (770 × 1380 × 900 mm L×H×D) with casters and leveling feet; optional integration into fixed infrastructure via flanged duct connections or HVAC interlocks.
• Pt-based noble metal catalysts (platinum or ceramic-coated variants) provide >99.9% H₂O₂ decomposition efficiency without regeneration, ensuring long-term operational stability and minimal maintenance intervals.
• High-capacity recirculation fan (up to 95 m³/h) coupled with the LiRo™ directional gas distribution system—featuring adjustable air nozzles and real-time feedback control—for homogeneous vapor dispersion across complex geometries.
• Onboard Ethernet and RS485 interfaces support integration with building management systems (BMS), SCADA platforms, and centralized validation databases.

Sample Compatibility & Compliance

The PEA-Series demonstrates broad material compatibility validated per ISO 10993-5 and USP , including polypropylene, polycarbonate, stainless steel 316L, silicone elastomers, and printed circuit boards. It poses no corrosion risk to calibrated sensors or optical components when operated within specified concentration (≤1000 ppm) and exposure duration limits. All hardware meets CE marking requirements under the Machinery Directive 2006/42/EC and Electromagnetic Compatibility Directive 2014/30/EU. Validation documentation—including IQ/OQ/PQ protocols, cycle development reports, and installation qualification templates—follows ASTM E2081 and PDA Technical Report No. 35 guidelines. Process verification adheres to ISO/IEC 17025-accredited laboratory practices.

Software & Data Management

The embedded HMI interface provides intuitive cycle setup, live parameter visualization (RH, temperature, H₂O₂ ppm, airflow), and alarm logging. All operational data—including timestamps, operator IDs, setpoints, deviations, and catalyst status—are stored locally on encrypted SD card and exportable in CSV or PDF format. Optional A4 thermal printer enables immediate hardcopy generation of cycle certificates with digital signature fields. Remote diagnostics and firmware updates are supported via secure HTTPS tunneling. Audit trails retain full traceability for GLP/GMP-regulated environments, with configurable retention periods (minimum 12 months) and role-based access control (administrator, technician, reviewer).

Applications

This system is deployed across regulated and research-intensive sectors requiring validated, repeatable biodecontamination: sterile manufacturing suites (aseptic filling lines, RABS, isolators), BSL-2/3 laboratories, vivariums with SPF rodent housing, military field-deployable containment units, and public health emergency response infrastructure. Its modular architecture supports both single-room decontamination and multi-zone synchronized treatment—such as simultaneous sterilization of interconnected cleanrooms using CEVA-type networked configurations. Integration with HVAC systems allows whole-facility treatment without disassembly, reducing downtime and validation burden.

FAQ

Does the PEA-Series require external hydrogen peroxide supply lines or bulk tanks?
No—it uses integrated peristaltic dosing of pre-filled, certified 30–35% H₂O₂ cartridges, eliminating plumbing complexity and cross-contamination risk.
Can the system be validated for use in FDA-registered pharmaceutical facilities?
Yes—full IQ/OQ/PQ documentation packages, protocol templates, and third-party validation support are available upon request.
What is the typical cycle duration for a 50 m³ isolator?
Standard cycles range from 90 to 180 minutes depending on initial RH, surface loading, and required log reduction; optimization services are included with commissioning.
Is catalyst replacement required during routine operation?
No—Pt-based catalysts maintain performance over ≥2000 cycles without regeneration or replacement under normal operating conditions.
How is residual H₂O₂ monitored and verified post-cycle?
Optional electrochemical H₂O₂ sensors (0–10 ppm range, ±0.1 ppm accuracy) can be installed at exhaust points; all units include catalytic breakdown verification via integrated thermal decay profiling.