IntroductionBIER-EO100 is designed to evaluate the resistance of biological indicators to ethylene oxide sterilization. It is intended for use by pharmaceutical and medical device manufacturers, regulatory authorities, third-party testing laboratories and biosafety facilities requiring traceable, repeatable resistance testing.
Features- Automated operation with one-touch water filling, sterilization cycle initiation and exhaust control.
- Data integrity and traceability with real-time monitoring and secure recording to verify sterilization conditions.
- Safety features including interlock door protection, automatic pressure relief, temperature staging and negative-pressure airtightness testing routines.
- High operational stability with rapid concentration response (rise/decline ≤ 10 s).
- Customizable programs and user-level management with one-click generation of standardized test reports.
Applications- Pharmaceutical production and quality control
- Medical device manufacturing and validation
- Biosafety and testing laboratories
Technical specifications- Monitoring method: US-brand sensors
- Sterilizer concentration: 100–1200 mg/L
- Sterilization temperature: 29°C–65°C
- Relative humidity (RH): 30%–80%
- Pressure range: 4–20 kPa
- Concentration rising period: ≤ 10 s
- Concentration decline period: ≤ 10 s
- Time to vacuum: ≤ 60 s
- Leakage rate: ≤ 0.13 kPa/min
- Single sterilization quantity: 20 pcs
- Management authority: three user levels meeting GMP requirements
- Electronic signature: yes
- Sterilization curve output: yes
- Power supply: 380 VAC / 50 Hz
- Power: 5 kW
- Dimensions (W×H×D): 112 × 183 × 105 cm
- Weight: 700 kg
- Test report: included