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Home > Container Closure Integrity Tester (CCIT) > CCIT – Bacterial Ingress Tester

BIT-L01S

CCIT – Bacterial Ingress Tester

External air source

Introduction

Features

Specifications

Compliance

Applications

Inquiry

The BIT-L01S container closure integrity tester (Dye Penetration/Microbial Challenge Method) is a specialized device for ensuring the integrity of sterile pharmaceutical packaging. It provides a comprehensive solution by integrating pressure control, microbial solution management, and protection, streamlining the entire process of microbial challenge packaging integrity testing.

CCIT Bacterial Ingress Tester

Self-Diagnostic Fuction

Adjustable Parameters

Permission Management

Features

  • Supports dye penetration and microbial challenge methods for sterile packaging integrity testing
  • Storage of multiple testing protocols, simplifying parameter configuration
  • Suitable for various packaging types, including powder injections and large-volume injectables
  • Custom-designed immersion racks ensure complete contact between samples and microbial solution
  • Automatically saves test data, which can be reviewed but not modified
  • Real-time data display via a color touchscreen
  • Switchable negative and positive pressure settings for more rigorous and consistent testing
  • Main unit and test tank are separate, with quick-connect pipelines to ensure safety and prevent leakage
  • Stainless steel test tank can endure 125°C steam sterilization, with flange-sealed openings to prevent leakage,
  • and an IP69 waterproof rating
  • All pressure adjustments and microbial solution management are conducted in a fully sealed environment
  • Traceable operations with exportable, unmodifiable records

Specifications

Main Unit Dimensions: 415 mm×430 mm×240 mm Weight: Approx. 18 kg
Test Tank Capacity: 10L, 20L, 30L (customizable Power: 220 V, ≤500 W
Formula Storage: 100 Alarms: 1. High or low tank pressure; 2. Self-check failure
Pressure Range: -90~＋400 KPa Pressure Accuracy: ±0.5 KPa
Automatic Bacterial Solution Filling: Speed-adjustable peristaltic pump(optional) Sample Loading Capacity: Depends on tank size and sample rack (customizable)

Compliance

  • Complies with GAMP5 validation standards
  • Adheres to NMPA CDE guidelines for the integrity of chemical injectable packaging
  • Fulfills USP43 1207.2 requirements for packaging integrity testing
  • Aligns with T/ZJPA 001-2023 standards for microbial challenge immersion tests in injectable packaging

Applications

  • Challenge tests for sterile packaging during transportation and storage
  • Pharmaceutical stability research and validation
  • Studies on the correlation between physical pore size and microbial penetration
  • Validation of physical inspection methods
  • Verification of crimping and sealing processes
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