Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
News|Articles|November 1, 2019
Maintaining Sterility and Stability of Injectables
Author(s)Pharmaceutical Technology Editors
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.
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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)
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