Container Closure Integrity Testing (CCIT) is critical to ensuring the safety and efficacy of pharmaceutical, biological, and vaccine products. The adequacy of container closure systems to maintain a sterile barrier against potential contaminants such as microorganisms, reactive gases, and other substances is evaluated through this assay. Synergy Bioscience is a company that specializes in providing state-of-the-art CCIT capabilities with uniquely qualified scientists to exceed client expectations.
Proper container closure systems are essential to maintain product and consumer safety. Primary packaging components such as glass vials or syringes come into direct contact with the product, while secondary packaging components like aluminum caps over stoppers are vital to ensuring correct package assembly. By understanding the container closure system, the assays, and established regulations and guidance documents, a compliant container closure integrity test can be established.
CCIT methods can be divided into deterministic and probabilistic categories, with a move toward more deterministic methods. The revised USP <1207> guidance series describes several methods available for use and removes the recommendation to compare CCIT methods to microbial ingress testing. During method development, a preliminary method is chosen, optimized, and qualified with target acceptance criteria and leak testing parameters established and optimized. Controls are created, and the quantity of samples for testing is sufficient to provide adequate assurance of package integrity.
Container closure integrity needs to be validated for each specific drug-product package, with validations typically performed in triplicate. All negative controls should pass, and all positive controls with leaks at or above the designated detection limit should fail. An integral package is one that conforms to specific product-package maximum allowable leakage limits. Routine and stability testing should be performed per an approved standard operating procedure or method, with package integrity re-evaluated when changes are required in package design, package materials, or manufacturing/ processing conditions.
Synergy Bioscience has the state-of-the-art equipment and uniquely qualified scientists to exceed client expectations in providing CCIT capabilities. Their expertise in CCIT can help ensure the safety and efficacy of pharmaceutical, biological, and vaccine products. If you are looking for reliable and high-quality CCIT capabilities, Synergy Bioscience is the right choice.
In conclusion, CCIT is critical to ensuring the safety and efficacy of pharmaceutical, biological, and vaccine products. Synergy Bioscience has state-of-the-art equipment and uniquely qualified scientists to exceed client expectations in providing CCIT capabilities. If you want to ensure the safety and efficacy of your products, contact Synergy Bioscience today to learn more about their CCIT services.
