Maintaining Sterility and Stability of Injectables
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)
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
