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

Specifications

ParameterSpecification
Air Changes≥50 ACH
Noise Level≤65 dB
Decon Time90-120 minutes
Glove Ports2-6 (quick-change)
MonitoringContinuous particle, pressure, temp/RH

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