In the dynamic and highly regulated world of pharmaceuticals, biotechnology, and medical devices, ensuring the integrity of product packaging is vital for maintaining safety and compliance. Container Closure Integrity Testing (CCIT) play a crucial role in verifying that packaging systems effectively safeguard products from contamination, leakage, and environmental factors. From initial feasibility studies to the development of precise test methods, and from stability testing to specialized helium leak detection, these services provide essential insights into the effectiveness of packaging solutions. By leveraging advanced technologies and methodologies, CCIT ensure products remain protected and meet stringent regulatory standards throughout their lifecycle.
Advanced Laboratory Testing Services
CCI testing services provide a comprehensive suite of solutions designed to assess and verify the integrity of packaging systems. Our CCI testing services encompass a range of specialized offerings, including:
Feasibility Studies: These experimental studies are the first step in determining the most suitable inspection technology and test method for a specific application. Our feasibility studies are backed by detailed reporting and comprehensive test result data, providing a solid foundation for subsequent testing and validation.
Test Method Development Support: Our services include the development and documentation of test methods, including advanced initial recipe creation, container qualification, and system suitability testing. We provide thorough testing and documentation to ensure the accuracy and reliability of test methods.
Stability Testing: This service ensures that products maintain container closure integrity throughout their stability period. Stability testing is crucial for verifying that packaging continues to protect the product over time, under various storage conditions.
Recall & Batch Release Testing: Designed for recalled products, products on hold, and batch release, this service provides critical testing to ensure product integrity and compliance before market release.
Helium Testing Services: Helium testing is used for a variety of purposes, including R&D work, component/material selection, packaging equipment qualification, and ongoing quality monitoring. Our helium testing services cover:
- Cold storage testing at temperatures ranging from -0°C to -160°C.
- Helium pre-filled and 100% Helium Flow Method testing.
- Compliance with USP 1207 standards.
- Testing for parenteral formats, blister cards, pouches/sachets, and various industrial applications.
- Package validation, component selection, stability sample testing, and R&D studies.
All leak testing is conducted in a non-GMP environment, ensuring flexibility and efficiency in testing procedures. Our CCI testing services are designed to meet the unique needs of each client, providing reliable and accurate results that support product quality and safety. These services are not just a regulatory requirement but a fundamental component of a commitment to quality and safety in product development and manufacturing.