The Applied Technical Services Family of Companies (ATS FoC) offers container closure integrity testing (CCIT) to assess pharmaceutical packaging and verify its ability to protect products during their shelf life. CCIT evaluates whether sealed packages maintain barriers against contaminants, microorganisms, gases, moisture, and other sources of degradation. Our services provide pharmaceutical and biopharmaceutical manufacturers with reliable data for development, validation, quality control, and regulatory compliance.
Which Pharmaceutical Packaging Systems Can Undergo CCIT?
Our CCIT services assess a wide range of primary and secondary pharmaceutical packaging components. Testing determines if the complete closure system provides necessary product protection. Our laboratory can evaluate packaging such as:
- Glass vials, ampules, stoppers, and septa
- Syringes, plungers, and barrels
- Flexible bags and other flexible packaging
- Aluminum caps and other secondary closure components
Testing supports packaging for pharmaceuticals, biologics, vaccines, sterile products, and other drug formulations. Evaluating the entire closure system provides manufacturers data on package performance and the risk of contamination or environmental impact on product quality.
About Our Container Closure Integrity Testing
Our laboratory offers comprehensive CCIT solutions using analytical methods tailored to the package, closure, and product characteristics. These services provide objective information on potential leaks and package integrity. Our container closure integrity testing services include:
- Dye ingress testing to identify potential package leaks
- Bubble emission testing for leak detection
- High voltage leak detection (HVLD) for suitable nonconductive containers and conductive solutions
- Vacuum decay testing for vials, ampules, syringes, flexible packaging, and other systems
- Laser headspace analysis for oxygen, carbon dioxide, and moisture
- Microbial ingress testing to evaluate resistance to microorganism penetration
- Sterility testing to assess the effectiveness of primary and secondary packaging
These services help manufacturers assess package integrity during development, qualification, validation, and quality programs.
How Are CCIT Test Methods Selected for Different Packaging Systems?
Selecting the appropriate CCIT method involves evaluating container material, closure design, product characteristics, leak size, and testing objectives. Our technical team reviews these factors to determine the best testing strategy for each system. Method selection may consider:
- Container and closure materials
- Product formulation and conductivity
- Liquid, lyophilized, or other product formats
- Required sensitivity and detection limits
- Primary versus secondary packaging
- Development, validation, or quality control objectives
Request a Quote
Our container closure integrity testing services provide the technical data manufacturers need to evaluate package performance, support validation activities, and maintain product quality throughout its shelf life. Submit an online inquiry or call +1 (888) 287-5227 to discuss your pharmaceutical packaging requirements, determine the appropriate CCIT method, and request a testing quote.
