ZebraSci Inc.

The investigation of the chemical compatibility between a drug product and its container relates to drug product quality, efficacy and safety - critical parameters for the development and commercialisation of a drug product. This implies assessing the extractables and leachables for each new drug product before submission for marketing authorization, and to re-evaluate requirements for each variation of an existing drug product. A 'Toxicological Risk Assessment' must also be conducted to evaluate patient exposure to chemicals over shelf-life and it is the responsibility of a Pharmaceutical company to provide timely evidence on the quality of their finished product. Tools & methodology for E&L studies can be deployed to anticipate challenges and provide key data to de-risk your drug combination product development, even at an early stage.

In this webinar, originally broadcast as part of the Pharmapack Europe show, Robert Schultheis, Founder & Chief Technology Officer, ZebraSci discusses: Probabilistic vs deterministic CCI Testing Presentation of the different deterministic CCI testing methods with applications and limitations What to consider when selecting CCI testing method In this session the audience will benefit from understanding the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activitiesbased on the advantages and limitations of different techniques available on the market

Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development. Several methods exist with different advantages and limitations.
During this session, we will address the following points: Probabilistic vs deterministic CCI Testing. Presentation of the different deterministic CCI testing methods with applications and limitations. What to consider when selecting CCI testing method.
At the end of the session, attendees should better understand the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market.