Container Closure Integrity Testing (CCIT) meeting the regulator requirements of EU GMP Annex 1 and following the guidelines of USP <1207>
Container Closure Integrity Testing (CCIT) is critical to ensure the sterility and stability of sterile injectable products. Recent regulatory guidelines (USP 1207) and requirements (EU GMP Annex 1) have led to changes in industry best practices for CCIT, with a focus on validated deterministic methods and the generation of science-based data.
Solutions for CCI testing activities
Container Closure Integrity Testing (CCIT) Method Development and Validation
To ensure effective container closure integrity testing (CCIT), it's crucial to use an appropriate method that fits the specific product container closure system configuration, product life cycle stage, and testing throughput requirements.At LIGHTHOUSE, we offer comprehensive analytical CCIT method development that's tailored to your specific product container configuration. Our approach involves optimizing the testing method to detect critical leaks, backed by scientific studies that determine the limits of detection. Additionally, we provide transfer and validation of the method through the provision of method validation protocols and on-site support to ensure protocol execution.
Headspace gas ingress Container Closure Integrity Testing (CCIT) as a replacement for blue dye ingress or microbial ingress testing.
Imagine replacing the blue dye in a dye ingress test with a tracer gas. Instead of relying on visual inspection to detect blue dye traces and potentially damaging products, use a Headspace Gas Analyzer to measure tracer gas ingress in a deterministic and non-destructive manner.With Headspace Gas Ingress CCIT testing, you can generate robust analytical CCI data at all stages of the product life cycle. This non-destructive testing method also allows for the development and validation of CCI test methods with analytical data.
Container Closure Integrity (CCI) during (ultra) deep cold storage and transport.
Certain sterile pharmaceutical products require deep cold storage at dry ice (-80°C) or even cryogenic (−196°C) temperatures to maintain their stability and activity. Examples of these products include viral vaccines, gene therapies, or products that contain active cells.Packaging components face a challenge in maintaining container closure integrity (CCI) during deep cold storage and transport. It is crucial to generate data that demonstrates the ability to maintain CCI under these extreme conditions. Ensure the integrity of your sterile pharmaceutical products with our deep cold storage testing solutions.
Headspace Vacuum Maintenance
SPharmaceutical formulations often require sealing under (partial) vacuum to ensure proper reconstitution and prevent interactions with headspace gasses. Regulatory guidelines such as the new EU GMP Annex 1 mandate that vacuum maintenance in product containers be checked over the product's shelf life.Laser-based headspace analysis allows for quick determination of headspace pressure in sealed pharmaceutical containers. This non-destructive measurement technique enables tracking of vacuum maintenance in samples over the entire product shelf life.
How do you comply with section 8.28 of Annex 1?
Section 8.28 of the new EU GMP Annex 1 states: “Where capping of aseptically filled sterile product is conducted as a clean process with grade A air supply protection, vials with missing or displaced stoppers should be rejected prior to capping. Appropriately qualified, automated methods for stopper height detection should be in place.”
Qualification of Raised Stopper Limits
LIGHTHOUSE laboratory service offers the solution! Use container closure integrity testing (CCIT) in order to determine at what stopper height displacement there is a risk of container closure integrity (CCI) failure. The data generated serve as a solid, science- based foundation of establishing the limits of the stopper height sensor. Using headspace analysis as a CCI test method enables justification of the set parameters, thereby safeguarding the product quality.
CCI of Freeze-Dried Product
Freeze-dried products are commonly packaged using a modified atmosphere headspace that includes a partial pressure of nitrogen. A straightforward headspace oxygen measurement can serve as an optimal CCIT (Container Closure Integrity Test), as it can identify any oxygen ingressThe vial sealing process during lyophilization and the extended time that a freeze-dried vial remains uncapped and uncrimped can increase the risk of seal integrity issues. Conducting a risk assessment can help determine the criticality of CCIT for freeze-dried vials, which may necessitate 100% CCI inspection during commercial production or for the re-work of CCI-at-risk batches.