Integrity tester BIT-L01S

CCITlaboratoryfor the pharmaceutical industry

Product Introduction
The BIT-L01S container closure integrity tester from CCIT performs bacterial ingress and dye penetration evaluations for sterile pharmaceutical packaging. Designed for controlled, traceable microbial challenge testing, the system integrates sealed pressure control, microbial solution handling and removable test tanks to support reproducible integrity assessments for vial, ampoule and large-volume injectable formats.

Features

• Supports dye penetration and microbial challenge (immersion) methods for container closure integrity testing
• Stores up to 100 test protocols for simplified parameter recall and validation
• Adaptable to multiple packaging types, including powder injections and large-volume injectables
• Custom immersion racks ensure full sample contact with microbial solution
• Automatic, traceable data saving with exportable, non-modifiable records
• Real-time monitoring via color touchscreen
• Switchable negative and positive pressure modes for rigorous, repeatable tests
• Separated main unit and test tank with quick-connect piping to reduce contamination and leakage risk
• Stainless steel test tank tolerates 125°C steam sterilization and uses flange-sealed openings
• IP69 rating for applicable components and fully sealed pressure/solution handling
• Built-in self-diagnostics and configurable user permission management

Specifications
Main unit dimensions: 415 mm × 430 mm × 240 mm
Weight: approx. 18 kg
Test tank capacity: 10 L / 20 L / 30 L (customizable)
Power: 220 V, ≤500 W
Protocol storage: 100 entries
Alarms: high/low tank pressure; self-check failure
Pressure range: -90 to +400 kPa
Pressure accuracy: ±0.5 kPa
Optional automatic bacterial solution filling: speed-adjustable peristaltic pump
Sample capacity: depends on tank size and rack configuration (customizable)

Compliance

• GAMP5 validation support
• Meets NMPA CDE guidance for injectable packaging integrity
• Complies with USP General Chapter 1207.2 (container closure integrity)
• Aligned with T/ZJPA 001-2023 for microbial challenge immersion tests

Applications

• Microbial challenge and dye penetration testing for sterile packaging during transport and storage
• Pharmaceutical stability studies and validation
• Correlation studies between physical pore size and microbial penetration
• Validation of visual and physical inspection methods
• Verification of crimping and sealing operations
• Integration into liquid preparation, radiopharmaceutical production and PUPSIT workflows

Technical specifications

• Main unit dimensions: 415 mm × 430 mm × 240 mm
• Weight: approx. 18 kg
• Test tank capacity: 10 L / 20 L / 30 L (customizable)
• Power supply: 220 V, ≤500 W
• Pressure range: -90 to +400 kPa
• Pressure accuracy: ±0.5 kPa
• Protocol storage: 100 entries
• Alarms: high/low tank pressure, self-check failure
• Automatic bacterial solution filling: optional speed-adjustable peristaltic pump
• Sample capacity: customizable by tank and rack design
• Materials and durability: stainless steel test tank, 125°C steam sterilizable; flange-sealed openings; IP69 where applicable
• Data management: automatic, traceable saving of test data (exportable, non-modifiable)
• Interface: color touchscreen with real-time data display