Sterility Testing Isolator

Basic specifications

• External Casing: STS304 2T
• Airflow: Vertical laminar air flow (Standard: 0.45m/s)
• HEPA Filter: 99.99% efficient at 0.3 microns
• HEPA Filter Protection Net: Mesh Screen (#200)
• Lighting: LED: embedded in the mesh screen
• Gloves: 10" Oval Acetal
• Pressure: 25Pa ± 10Pa during Sterility Testing

Alarm related

• Alarm message display (popup) & buzzer
• Display the action screen when checking the alarm
• Alarm history backup to USB (authorization setting)

Log & back up

• Logging of various data
• Save and backup as Excel file or PDF file
• Save VHP Cycle Recipe
• Saving and outputting result report as PDF file after sterilization
• 21 CFR Part 11 Compliance

Glove Leak Tester

• Including installation and commissioning
• Data storage and report output - PDF storage, dot printer output
• 21 CFR Part 11 Compliance