Maintaining Sterility and Stability of Injectables

November 1, 2019

On Wednesday Nov. 6, 2019, Dr. Derek Duncan from Lighthouse Instruments will summarize the current state of container closure integrity testing (CCIT) in the bio/pharma industry and will outline a framework for the development of a holistic testing strategy.

On Wednesday Nov. 6, 2019, Dr. Derek Duncan from Lighthouse Instruments will summarize the current state of container closure integrity testing (CCIT) in the bio/pharma industry and will outline a framework for the development of a holistic testing strategy.

CCIT is important in the maintenance of stability and sterility of injectable products, particularly in light of the fact that any defects in injectables that cause a sterile leak in the vial are not always necessarily defects that will be detected by visual inspection. New regulatory guidance on CCIT is creating a shift in the way in which testing is being approached, with traditional methods being described as associated with probabilistic outcomes.

Additionally, as a result of new regulatory guidance, testing should now be performed throughout the product lifecycle. There are deterministic CCIT methods available that are based on non-destructive analytical measurements, which when coupled with a risk-based approach can be used to generate statistical data for container closure integrity that may be useful in making decisions about inspection processes for commercial manufacturing.

Container Closure Integrity Testing of Sterile Pharmaceutical Product Throughout the Product Life Cycle

Wednesday Nov. 6, 2019

15:50–16:20

InnoPack & P-MEC Theatre (110D50)