Sterility Testing Isolator
Sterility Testing Isolator
Key Applications:
Pharmaceutical sterility testing
Cell culture and media preparation
Aseptic process simulation
Hazardous drug handling
Medical device testing
Technical Specifications
Critical Components:
Airflow System: Unidirectional laminar flow (0.45±0.1 m/s)
Filtration: H14 HEPA (99.995%) or U15 ULPA (99.9995%)
Decontamination: Automated VHP cycle (6-log reduction)
Construction: 316L stainless steel frame, tempered glass panels
Control System: PLC with 10″ touchscreen, 21 CFR Part 11 compliance
- Material:
- Contact Person:
Specifications
Parameter | Specification |
Air Changes | ≥50 ACH |
Noise Level | ≤65 dB |
Decon Time | 90-120 minutes |
Glove Ports | 2-6 (quick-change) |
Monitoring | Continuous particle, pressure, temp/RH |