Container Closure Integrity Testing (CCIT)

Last week, Contract Laboratory received a request from a company needing container closure integrity testing (CCIT) of an injectable drug product. Integrity testing of the containers of pharmaceutical products is a critical step in ensuring the product is safe and unadulterated as it evaluates the strength and integrity of the closure system and its ability to maintain a sterile barrier.

Container closure integrity testing checks the materials and chemicals for the potential to migrate and/or leach into the drug product, causing contamination. Contaminants include microorganisms, gases, and other substances. Methods for determining the safety of container closures include dye ingress, microbial immersion, vacuum or pressure decay, and high voltage leak detection. Integrity testing of the container systems includes testing primary packaging, or anything that comes into direct contact with the product, and secondary packaging, components necessary for packaging assembly.

Are you in need of a laboratory to perform container closure integrity testing on your product? We can help save you time and money! Call 1-855-377-6821 or visit our website to submit a test request!

The following are a few of the test requests Contract Laboratory has received and helped facilitate:

• FDA GMP Pharmaceutical Packaging Laboratory needed for container closure integrity testing for parenteral drug product.
• Pharmaceutical laboratory needed too perform Integrity testing of Injectable drug product (Vial) as per USP 1207, Container Closure Integrity Testing (CCIT)
• Europe pharmaceutical laboratory needed for biopharmaceutical method development and method validation and routine GMP Testing of parenteral lyophilized protein biopharmaceutical packaged in a rubber stoppered glass vial. Container closure integrity testing, method DEVELOPMENT, VALIDATION AND ROUTINE gmp TESTING Container closure integrity testing for routine GMP release testing. Also development and verification testing for lyo glass vial under new gudances.
• Pharmaceutical packaging laboratory needed for container closure (torque) testing for Ciprofloxacin(0.3%) / Dexamethasone (0.1%) Otic Sterile Suspension? FDA cGMP packaging laboratory needed to perform container closure integrity testing by Helium Leak Detection
• DA GMP Midwest USA Pharmaceutical Packaging Laboratory needed for FDA Container Integrity Testing: CCI Testing either Dye Immersion or Container Closure Integrity Test Bacterial of 1mL, and 3ml glass vial; 1mL glass vial w/27G needle. Type of product: biosimilar parenteral drugs
• Packaging Laboratory needed for container closure analysis of 0.5 mL of a lyophilized protein solution in a 12 x 75 mm serum vial with rubber stopper. This product will be sent to the FDA for licensing, so we are looking for an FDA approved method. I have looked into the standard methylene blue test, but don?t hink if this is the best method for our product. I see that you use the vacuum decay test method and was wondering if you could provide an overview of that method and would you recommend it for our product.
• South America FDA GMP Packaging Laboratory needed for GMP Container Closure Integrity (CCI) testing.
• View all our test requests here!