Integrity tester BIT-L01

CCITlaboratoryfor the pharmaceutical industry

Introduction
The CCIT Bacterial Ingress Tester BIT-L01 is designed to evaluate and verify container closure integrity for sterile pharmaceutical products in accordance with GMP requirements. The instrument applies adjustable positive and negative pressures to assess microbial barrier performance and sealing quality of packaging containers.

Features

• Accommodates test samples of various specifications and container types
• User-friendly operation with quick-connect tank connector
• Compact footprint for laboratory and production environments
• Transparent, high-strength test vessel for visual observation; resistant to high temperature and pressure
• Safe test procedure minimizing risk of microbial leakage
• Built-in gas supply components; no external gas source required
• Equipment self-test and multi-level user authorization for secure use
• Real-time printing of test identification and process data

Specifications (table)

• Pressure adjustment range: -80 to +100 kPa
• Pressure adjustment accuracy: ±0.5 kPa
• Pressure detection accuracy: ±0.25 kPa
• Pressure reading resolution: 0.1 kPa
• Gauge pressure error: ±0.5 kPa
• Keep time: 0–999 min
• Infusion flow: 0–1500 mL/min
• Test vessel sterilization: Autoclave sterilization
• User authority: 3-level user management
• Monitoring parameters: Time, Pressure
• Recipe edit & recall: Supported (storage ≥ 100)
• Data export: Exportable in report format
• Data printing: Dot-matrix micro printer
• Power consumption: ≤500 W
• Alarms: overpressure/under-pressure, self-diagnostic failure, pressure deviation

Applications

• Container closure integrity testing for sterile drug containers
• Qualification of capping and sealing processes
• Validation of physical inspection methods
• Correlation studies between orifice size and microbial barrier performance
• Drug stability studies and process validation
• Microbial challenge testing for transport and storage conditions of sterile packages

Technical specifications

• Model: BIT-L01
• Pressure adjustment range: -80 to +100 kPa
• Pressure adjustment accuracy: ±0.5 kPa
• Pressure detection accuracy: ±0.25 kPa
• Pressure reading resolution: 0.1 kPa
• Gauge pressure error: ±0.5 kPa
• Keep time: 0–999 min
• Infusion flow: 0–1500 mL/min
• Test vessel sterilization: Autoclave sterilization
• User authority: 3-level user management
• Monitoring parameters: Time, Pressure
• Recipe storage: ≥ 100 records
• Data export/printing: Report export and dot-matrix micro printer
• Alarms: overpressure/under-pressure, self-diagnostic failure, pressure deviation
• Power: ≤500 W
• Design notes: Compact design; transparent high-strength test vessel; built-in gas source; equipment self-test