CCIT- Container closure integrity testing plays an important role in pharmaceuticals for the products safety, stability and sterility. Chromak Research team has an extensive range of Container Closure Integrity methods, techniques and analysis for various packaging and delivery systems to meet the desires of pharmaceutical, microbiology, biotechnology and medical device manufacturers.
As the powerful forces behind safety evaluation of materials and container closure systems in the US, the United States Pharmacopeia (USP) and Food and Drug Administration (FDA) apply strict guidelines for Container Closure Integrity Testing (CCIT).
Container closure systems contain two types of components – primary packaging components and secondary packaging components. Primary packaging components e.g., glass vial or syringe which are direct contact with the product. While, secondary packaging components e.g., aluminum caps over stoppers which are vital to ensure correct package assembly. (USP <1207>).
Following various standards exist to deal with the quality and testing of Container and packaging.
• USP (1207) Sterile Product Packaging-Integrity Evaluation
• USP (1207.1) Package Integrity and Test Method Selection
• USP (1207.2) Package Integrity Leak Test Technologies
• USP (1207.3) Package Seal Quality Test Methods
• Code of Federal Regulations (CFR): 21CFR211.94 Drug Product Containers and Closures-
o Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
o Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
o Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated.
• Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures
• Compositional requirements, test procedures and acceptance criteria on materials for containers is also defined European Pharmacopeia Section 3.
• FDA’s 1994 Guidance for Industry for the Submission of Sterilization Process Validation in Applications for Human and Veterinary Drug Products- Evaluate the tests and studies performed to demonstrate the integrity of container / closure systems for all sterile drugs, including:
oVerify that all incoming container-closure components meet specifications, including all appropriate dimensions.
o Determine studies adequately simulate the stress conditions of the sterilization process, handling and storage.
o Verify that the units tested in validation are appropriate (e.g., for terminally sterilized drug product, the units selected should be exposed to the maximum sterilization cycles using the production process).
o Sensitivity of the test is specified.
o Container-closure integrity is demonstrated during validation and as part of the stability program (in lieu of sterility testing), over the shelf life of the product.