About Us Contact Us Resources News & Events Technical Support Careers Applications Products Services Life Cycle Container Closure Integrity Testing Home • Container Closure Integrity Testing • Container Closure Integrity (CCI) Testing throughout the Product Life Cycle. CCI testing plays an important role in maintaining the sterility and stability of sterile injectable products. Recent regulatory guidance and requirements are influencing changes in industry best practices for CCI testing. Emphasis is being put on implementing validated deterministic CCI testing methods and generating science-based CCI data. LIGHTHOUSE offers solutions for CCI testing activities based on non-destructive laser-based headspace analysis. These solutions can be applied to various activities throughout the product life cycle in Development, Manufacturing and Quality Control. Solutions for CCI testing activities CCI Test Method Development and Validation Gas Ingress CCIT as Replacement for Blue Dye Ingress and/or Microbial Ingress testing CCI during Deep Cold Storage & Transport Headspace Vacuum Maintenance Qualification of Raised Stopper Limits CCI of Freeze-dried Product Article: Industry Survey on Best Practices in CCI Testing Webinar: A Science-based Approach for Ensuring Container Closure Integrity of sterile vials Article: Regulatory Guidance in Designing a Strategy for CCI Testing Article: A Holistic Strategy to Ensure CCI of Sterile Vials CCI Testing Method Development & Validation An appropriate CCI test method should be applied for the specific product container closure system configuration used, the stage in the product life cycle, and the testing throughput required. LIGHTHOUSE offers robust analytical CCI testing method development, optimizing the method per customer product container configuration, demonstrating the detection of critical leaks with scientific studies, and determining limits of detection. Customers are supported with transfer and validation of the method through the provision of method validation protocols and on-site support with protocol execution. Article: Container Closure Integrity Test Method Development using Headspace Gas Ingress Case Study: CCI Test Method Validation for Prefilled Syringes Webinar: CCIT Method Development Gas Ingress CCIT as Replacement for Blue Dye Ingress and/or Microbial Ingress testing Imagine a blue dye ingress test but replace the dye with a tracer gas. Instead of visually inspecting containers to observe traces of blue dye and destroying valuable product, ingress of a tracer gas can be deterministically and nondestructively measured with a Headspace Gas Analyzer. Headspace Gas Ingress CCI testing is capable of generating robust analytical CCI data in all stages of the product life cycle. The non-destructive nature of the test and the generation of analytical data enables robust method development and validation of CCI test methods. Article: Evaluating the Container Closure Integrity of a Vial Using Headspace Gas Ingress Methods E-Book: Headspace Gas Ingress as a Replacement of Dye Ingress for CCI Testing Webinar: Headspace Gas Ingress testing for CCI Article: Gas Ingress Methods as Replacement of Blue Dye Ingress Testing for CCI Article: Method Development for a CCI Test Using Headspace Gas Ingress Product note: CCIT Vessel Headspace Gas Ingress Testing CCI during Deep Cold Storage & Transport Certain sterile pharmaceutical products require deep cold storage, either at dry ice (-80°C) or even cryogenic (−196 °C) temperatures. Viral vaccines, gene therapies, or products that contain active cells (cell therapies) often need deep cold storage temperatures to maintain stability and/or activity. Such storage conditions pose a challenge to packaging components. It is therefore imperative that data is generated to demonstrate the maintenance of container closure integrity during deep cold storage and transport Application Note: CCI of Products Requiring Deep Cold Storage Article: Effects of Deep Cold Storage on CCI eBook: Container Closure Integrity and Deep Cold Storage Case Study: Container Closure Integrity Testing for Sterile Vial Products in Deep Cold Storage Case Study: Ensuring CCI of Gene Therapy Cancer Vaccine needing Deep Cold Storage Case Study: Generating RSF & CCI Correlation Data to Ensure Container Closure Integrity Article: CCIT Method Development for Vials in Deep Cold Storage Webinar: Container Closure Integrity of Product Requiring Deep Cold Storage Headspace Vacuum Maintenance Some pharmaceutical formulations are sealed under (partial) vacuum to ensure proper reconstitution or to prevent interactions between the formulation and headspace gases. Regulatory guidelines require checking maintenance of vacuum in product containers over the shelf life of the product. Laser-based headspace analysis enables a rapid determination of the headspace pressure in sealed pharmaceutical product containers. Due to the nondestructive nature of the measurement, vacuum maintenance in samples can be followed over the entire product shelf life. Case Study: Vacuum Maintenance Qualification of Raised Stopper Limits LIGHTHOUSE provides solutions for stopper height sensor qualification and validation of raised stopper limits. Scientific studies using laser-based headspace analysis can be executed to correlate the probability of CCI failure to raised stopper height. Raised stopper limits are determined for rejecting product at risk for loss of CCI. Assessing The Effects Of Raised Stoppers On CCI CCI of Freeze-Dried Product Freeze-dried product is often packaged with a modified atmosphere headspace consisting of a partial pressure of nitrogen. Therefore, a simple headspace oxygen measurement can be an optimum CCI test: detection of oxygen ingress identifies a CCI defective vial. The vial sealing process in the lyo chamber and extended time that a freeze-dried vial remains uncapped and uncrimped can introduce risk to the seal integrity of the container. A risk assessment may therefore conclude that CCI testing of freeze-dried vials is critical. 100% CCI inspection is often implemented in commercial production or for the re-work of CCI at risk batches. Application Note: Stopper ‘Pop-Up’ and the Effects on Container Closure Integrity of Freeze-Dried Vials Application Note: Sterile production process studies using 100% headspace inspection of finished product Case study: 100% CCIT of freeze-dried product Container Closure Integrity Testing Quick Links APPLICATIONS Container Closure Integrity Testing Oxygen Monitoring Water Activity Determination Moisture Determination PRODUCTS Automation Laboratory Instruments SERVICES Lab Testing On-site Testing Equipment Lease LIFE CYCLE Development Manufacturing Quality Control Contact Us Wherever you need support optimizing product and process quality throughout the product lifecycle, LIGHTHOUSE experts are available for you. 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