BIT-L01

CCIT – Bacterial Ingress Tester

Designed to perform testing of and verify the container closure integrity

The CCIT- Bacterial Ingress Tester is critical to maintaining the sterility of drugs intended to be sterile. GMP specifies that the integrity of packaging & containers shall be validated for the pharmaceutical products.

Tailin Container Closure Integrity Tester BIT-L01: specifically designed to perform testing of and verify the container closure integrity. By setting different pressures, it can verify the microbial barrier performance of specific packaging containers and sealing quality.

Compact design, saves space

Safe and reliable use process, no microbial leakage

Built-in gas source components, no external gas source required

Features

  • Test samples of different specifications of various products
  • Easy to operate, easy to plug and unplug the tank connector
  • Compact design, saves space
  • The test tank is made of colorless, transparent, high-strength material, resistant to high temperature and high pressure, and easy to observe the test results
  • Safe and reliable use process, no microbial leakage
  • Built-in gas source components, no external gas source required
  • Equipped with an equipment self-test function to ensure safe use
  • Real-time printing function of basic test information and test process data

Specifications

Pressure Adjustment Range: -80 ~ +100KPa Test Vessel Sterilization: Autoclave sterilization
Keep Time: 0-999min User Authority: 3-level user authority management
Pressure Adjustment Accuracy: ±0.5KPa Alarm:1.Test vessel overpressure/under-pressure alarm
2.Self-diagnostic failure alarm
3.Test vessel pressure deviation alarm
Pressure Detection Accuracy:±0.25KPa Monitoring Parameters:Time,Pressure
Pressure Reading Resolution:0.1KPa Recipe Edit &Recall:Support
Gauge Pressure Error. ±0.5KPa Data Export:Support data export in the form of reports
Infusion Flow:(0~1500)mL/min Data Printing:Dot matrix micro printer
Recipe Storage Capacity:No less than 100 Power:≤500W

Applications

  • Evaluation of the consistency of injections — Package Integrity Test
  • Qualification of the capping & sealing process
  • Verification of the validity of physical inspection methods
  • Establishing a relationship between orifice size and microbial barrier performance
  • Drug stability study and validation
  • Microbial challenge testing on conditions for transport and storage of sterile packages
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