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The pharmaceutical and life science industries rely on package integrity to maintain product efficacy throughout the shelf life of a drug or biologic. Container Closure Integrity (CCI) testing forms a foundation for sterile product delivery, helping companies maintain consistency and meet stringent regulatory requirements. PTI offers a complete suite of CCI services tailored to every phase of product development and commercialization. From test method development and validation to analytical testing and ongoing system support, these services provide a pathway for organizations to implement robust CCI programs.

Comprehensive Life Science Services Offered by PTI

1. CCI Development Services

CCI development services support method creation, refinement, and validation aligned with industry standards. The process begins with Initial Recipe Creation (IRC), where measurements are performed on both defective and intact samples using various test parameters. These values are analysed to develop a starting method, which includes proposed reject limits and a comprehensive data summary.

The next step is Test Method Development, focusing on building a reliable and sensitive method through system suitability testing and statistical analysis. Proprietary equipment and dedicated facilities are used for this stage, with optional on-site testing available.

Once the method is defined, PTI offers Method Validation Support, providing execution templates based on USP <1207>, hands-on engineering support, and documented validation of method performance. Each stage concludes with a final report and client consultation to maintain transparency and alignment throughout the process.

2. CCI Analytical Testing

PTI delivers contract-based CCI analytical services that support manufacturers. Batch testing is conducted using deterministic technologies like Vacuum Decay and MicroCurrent HVLD, delivering high-sensitivity results that meet industry and regulatory expectations. For new packaging formats or inspection approaches, experimental feasibility studies help determine the most effective testing solution. These studies generate data on test viability and guide further method development. In addition, Limit of Detection (LOD) Studies define the smallest defect size a method can consistently identify. LOD studies often include laser-drilled samples and statistical analysis, offering valuable data for regulatory submissions.

Helium Leak Testing services are also available and widely used across pharmaceutical and industrial sectors. These services support R&D, process control, and large-scale testing programs with precision and speed. For products requiring ultra-low temperature storage, Cold Storage Testing is offered using helium-based methods down to –160°C, allowing accurate testing of frozen or cryogenic samples using both glass and plastic packaging formats.

3. CCI Campus – CCI Consulting & Training

The CCI Campus initiative provides extended support through consulting and training services for those seeking to implement or enhance package integrity programs. CCI consulting spans early-phase development to commercial scale-up, offering strategic guidance on test method selection, protocol implementation, and packaging challenges.

Consulting engagements also cover sample plan design, interpretation of CCI data, and compliance alignment with USP <1207>, USP <382>, and EU Annex 1 standards. For hands-on knowledge transfer, training programs are available for professionals at all levels. These sessions cover everything from regulatory overviews and MALL concepts to method comparison and system-specific training.

4. CCI Care+

The Care+ program is a comprehensive service support offering designed to sustain equipment performance and testing reliability over time. The Platinum Annual Service Contract includes calibration, documentation support, system optimization, and discounted software upgrades. Clients benefit from direct access to expert technical support for prompt issue resolution and ongoing system enhancement.

PTI also offers our Care+ GMP Turnkey Solutions – providing comprehensive, end-to-end support for Container Closure Integrity (CCI) compliance.

As part of this service suite, the Seal Quality Assurance Program focuses on flexible packaging applications. Leveraging proprietary Seal-Scan® airborne ultrasound technology (ASTM F3004), it delivers precise, non-destructive seal quality inspection for pouches and related materials. This method enhances seal validation by identifying potential defects with a high degree of sensitivity. Through Care+, clients receive a proactive maintenance strategy paired with advanced inspection capabilities to keep systems operating at peak performance.

CCI Life Science Services offer a unified approach to addressing the multifaceted requirements of container closure integrity. From initial test method creation to long-term equipment performance support, these services are structured to provide clarity, compliance, and consistency. By combining science-based methods, regulatory alignment, and dedicated service, Life Science CCI Services serve as a dependable resource for ensuring packaging integrity across diverse product lines.