Container Closure Integrity Testing (CCIT)

Container closure integrity testing ensures the sterility and stability of a product.
Container closure integrity testing ensures the sterility and stability of a product.

Container closure integrity testing is done to evaluate the strength and integrity of a container closure system. Testing of container closures is important as it ensures a sterile barrier against microorganisms and other potentially dangerous contaminants.

Containers and closure systems receive testing of both primary, components that come into direct contact with a product, and secondary packaging components, those most important for ensuring the packaging is assembled correctly.

Container closure integrity testing is a heavily monitored industry and is closely regulated by the FDA because of the importance of product and consumer safety. CCI testing is an alternative to performing sterility testing as a means of proving shelf-life and product safety. Many companies even prefer CCI testing because of its quick turnaround time and ability to identify a leak or weak point in a system.

Container closure systems must protect the product as well as the environment as any cracks or holes can result in unwanted gases or other harmful substances escaping. Test methods for container closure integrity testing include dye ingress, vacuum decay, headspace analysis, helium leak, high voltage leak detection and more.

Contract Laboratory has received numerous requests from pharmaceutical, biotechnology, life science and medical device companies needing container closure integrity testing, including the following:

  • FDA GMP Pharmaceutical Packaging Laboratory needed for container closure integrity testing for parenteral drug product.
  • 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
  • FDA 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.

And many more packaging projects! To view more Container Closure Integrity and Packaging Testing projects that Contract Laboratory has helped with outsourcing, visit Packaging View Packaging Test Requests

NEED PACKAGING TESTING?

Container closure integrity testing is important as it ensures the sterility and stability of pharmaceutical, life science, biotechnology, biologics, and medical device products. If your pharmaceutical, biotechnology, life sciences or medical device company needs packaging  laboratory to perform container closure integrity testing or other scientific research, call us at 1-855-377-6821 or submit a  container closure integrity or packaging test request online.

Originally posted 2017-02-27 16:39:37.