VHP Generator-EN

Product Overview

With a sterilization capacity of 5-100m³ and cycle times of 30-90 minutes, it achieves a 6-log reduction (99.9999%) in microbial load—compliant with EN 1422 and CE IVDR regulations. The touchscreen-controlled system features automatic dosage calculation, residual air purge, and real-time process monitoring. Constructed with 316L stainless steel, it’s suitable for pharmaceutical cleanrooms, medical device facilities, and biosafety laboratories across Europe and global markets.

Scenario-Based Solutions

Pharmaceutical Aseptic Processing

In sterile drug production (injectables, ophthalmics), the VHP Generator EN sterilizes filling machines, isolators, and cleanroom zones before batch runs. Its programmable cycles adapt to different room volumes, while the residual sensor ensures H₂O₂ levels <1ppm post-sterilization—meeting FDA and EMA requirements.

Medical Device Manufacturing

For Class III medical device (e.g., stents, implants) facilities, the generator sterilizes packaging areas and equipment surfaces. The dry vapor process avoids moisture damage to electronics, and the data logging system provides traceable records for MDR (Medical Device Regulation) audits.

Biosafety Laboratory Decontamination

In BSL-2/3 labs handling pathogens, the VHP Generator EN decontaminates biosafety cabinets, pass boxes, and waste storage areas. The portable design (caster-mounted) allows flexible use, while the leak detection system ensures operator safety.

Key Product Features

CE-certified: compliant with EN 1422, 2014/34/EU (ATEX), and IVDR 2017/746.

Automatic dosage: 0.5-7mg/L H₂O₂ concentration adjustment based on room volume.

Residual control: integrated catalytic converter reduces H₂O₂ to <1ppm in 15 minutes.

Remote monitoring: WiFi connectivity for process control via mobile/PC.

Safety features: door interlock, overpressure alarm, and emergency stop.

Technical Support & Related Services

We provide CE compliance support (technical file preparation), on-site installation, and validation services (DQ/IQ/OQ/PQ). Operator training covers cycle programming, safety protocols, and maintenance. Spare parts (H₂O₂ cartridges, filters) are available with 48-hour EU delivery. We offer annual calibration and process optimization for new applications, plus regulatory consultation for MDR/FDA submissions.

FAQ

Q1: What concentration of H₂O₂ is used, and is it safe for equipment?

A1: Concentration ranges 0.5-7mg/L (adjustable). The dry vapor (≤6% humidity) is safe for electronics, stainless steel, and most plastics. We provide a material compatibility list for custom applications.

Q2: How long does a typical sterilization cycle take?

A2: For a 50m³ room: 30-minute conditioning, 40-minute sterilization, 20-minute residual purge—total 90 minutes. Smaller spaces (e.g., 10m³ isolators) take 45 minutes total.

Q3: Is the generator compatible with existing cleanroom HVAC systems?

A3: Yes. It connects to HVAC via duct adapters or operates in standalone mode. Our engineers will design integration to avoid pressure fluctuations and ensure uniform vapor distribution.

TKSAGE-EN uses low-temperature flash vaporization technology to achieve complete vaporization of hydrogen peroxide; The process saturation control technology is adopted to realize no liquefaction and no condensation in the whole process of sterilization; The process monitoring parameters include: temperature, relative humidity, hydrogen peroxide concentration and vapor saturation; The adjustment parameters include: flash temperature, circulating air volume, and peristaltic pump injection rate; The safety control parameters include: hydrogen peroxide concentration, saturation and hydrogen peroxide residual concentration; The VHP generator is integrated with the catalytic degradation, making the sterilization more convenient and faster.

Pipeline connection

Drawings of TKSAGE-EN II VHP generator	Pipeline connection diagram

VHP sterilization curve