CCI Analytical Testing

914.337.2005

Batch Release Testing

PTI offers contract CCI batch release testing services for pharmaceutical and biologics manufacturers seeking third-party verification of container closure integrity. Using non-destructive, deterministic technologies such as Vacuum Decay and MicroCurrent HVLD, PTI provides high-sensitivity testing that aligns with USP <1207> and FDA expectations.

Our experienced team ensures rapid turnaround and traceable documentation, enabling sterile batch release with confidence while reducing internal resource strain. This service is particularly beneficial for high-value drug products and companies without in-house CCIT capabilities.

Test Method Development for Container Closure Integrity Testing

Experimental Feasibility Studies

Experimental feasibility studies are the foundation for identifying the most appropriate inspection technology and test method for a given packaging system. These studies help determine if a particular test approach is viable and effective for the specific application.

Each study is supported by comprehensive test data and reporting, offering insight into method suitability, potential limitations, and recommendations for further development or validation.

Limit of Detection (LOD) Studies

The Limit of Detection (LOD) represents the smallest defect size a test method can consistently identify, playing a critical role in evaluating CCIT method sensitivity. Establishing the LOD is vital to demonstrate that the chosen method can detect critical leaks that could compromise sterility.

PTI’s LOD studies are designed to determine the lowest detectable leak rates using technologies such as helium leak detection and non-destructive methods like MicroCurrent HVLD and Vacuum Decay. Utilizing laser-drilled defects and rigorous statistical analysis, these studies support regulatory submissions and align with MALL (Maximum Allowable Leakage Limit) requirements for sterile drug products.

PTI Equipment Support & CCIT Application Support

Helium Leak Testing Services

PTI provides comprehensive Helium Leak Testing services through our Centers of Excellence in Hawthorne, NY, and St-Prex, Switzerland. These services support R&D, material selection, equipment qualification, and ongoing quality control efforts.

Helium Leak Testing is considered the gold standard for package development, offering precise, quantifiable data critical to evaluating package integrity. With deep expertise and a proven track record across pharmaceutical and industrial sectors, PTI tailors its testing solutions to meet the specific requirements of each client whether for small-scale studies or large-volume testing programs.

Expertise: Our organization boasts a wealth of knowledge and experience in helium leak testing. We have a proven track record of assisting pharmaceutical companies in assuring packaging integrity. From start-up entities to large pharmaceutical organizations, we have worked with a wide variety of clients.
Prime Test Method: Helium Leak Testing is the prime method for Package Development and R&D data. It provides precise, quantifiable, reliable results crucial for your packaging development process and quality requirements.
Wide Application Experience:We have successfully provided Helium Leak Testing services across the pharmaceutical and industrial sectors. Our extensive experience allows us to tailor our approach to meet your specific needs. Whether you have ten samples or hundreds, we can provide the proper helium leak test method and develop the data you require.

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Benefits of CCI Helium Services

As you consider Helium Leak Testing for pharmaceutical packaging, you'll appreciate our approach:

Cost-Efficiency

Unlike some testing methods, we can generate leak rate data without the need for a full feasibility study. This not only saves significant time but also eliminates unnecessary expenses.

Reliable Data

With Helium Leak being a Deterministic method, there are no questionable results as would be the case of probabilistic methods. No operator subjectivity.

Time Savings

Compared to headspace analysis, helium leak testing can be performed in less than a day as opposed to many days.

Flexibility

We offer the flexibility to tailor our testing services to your specific needs without the added expense of operating under strict GMP guidelines.

For Pharmaceutical Package applications, we can readily test the following container formats:

Vials: Glass & Plastic versions – crimp seal only or entire vial container.

Cold Temperature Vial Leak Testing – temp range -20° to -160°C.

Syringes & Cartridges - Glass & Plastic versions – Plunger, Crimp, & Needle Shield seal areas.

Foil Blister Cards & Foil Sachets/Pouches – heat seal perimeter and entire package seal.

Tubes – Foil and Foil Laminate versions – Closure/threaded cap & crimp end seals.

IV Bags utilizing the Helium Sniffer Mode test process.

Plastic Containers/Bottles – Closure/threaded cap & Induction seal areas.

Devices – single leak sites or multiple locations can be analyzed

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Cold Storage Testing

Helium testing service that utilizes the Cryo Chiller module to test products which need to be stored at subzero ultra cold temperatures.

100% Helium Flow at Cold temperatures
Samples can be tested at a wide range of temperatures:
from –20° to –160°C.
Both Glass and Polymer (plastic) can be used for low-temperature helium leak rate analysis.

914.337.2005