Mahant Pharma Advances

CCIT Testing Kit

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Mahant Pharma Advances offers high-quality Container Closure Integrity Testing (CCIT) Kits designed to help pharmaceutical manufacturers ensure product sterility and compliance with regulatory standards. Our CCIT Testing Kits are the best choice for validating vacuum decay, high-voltage leak detection (HVLD), pressure decay, and other CCIT methods. As a leading CCIT Testing Kit manufacturer and supplier, we provide strong solutions for simulating micro-leaks and verifying the integrity of vials, ampoules, and syringes. Each Container Closure Integrity Testing Challenge Kit is certified and designed for accurate testing.

 

CCIT Testing Kit includes

  1.   Positive and negative control samples with known leakage or defects
  2.  Sample containers (vials/ampoules/syringes) with engineered leak paths
  3.   Leak simulation accessories (e.g., micro-drilled caps, defective seals)
  4.   Documentation with defect classification and certification
  5.   Optional compatibility with:
    • Vacuum decay
    • High-voltage leak detection (HVLD)
    • Pressure decay
    • Blue dye ingress
    • Helium mass spectrometry

Features Of CCIT Testing Kit

Our CCIT kits are built for accuracy,eco-friendliness, and across multiple leak detection technologies.

  • FDA & GMP compliant
  • Certified challenge kits with artificial defects
  • Supports vacuum decay, HVLD, pressure decay methods
  • Customizable for various container types
  • Reusable and long-lasting design
  • Traceable and documented defect samples
  • Global availability and support
  • Trusted by leading pharmaceutical companies

Applications of CCIT Testing Kit

  • Container closure integrity testing

  • System calibration and validation

  • Operator training for CCIT methods

  • Following industry standards and audits

  • Micro-leak detection testing

  • Qualification of automated CCIT systems

  • Routine performance checks for in-process control

  • Compliance with USP , Annex 1, and PDA Technical Reports

Benefits of CCIT Testing Kit

  • Supports method development and validation
  • Ensures consistent and reliable leak detection
  • Assists in FDA/EMA compliance during inspections
  • Reduces product loss due to undetected leaks

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