Nelson Labs


Does a container closure integrity test (CCIT) failure always mean a defective closure? In this webinar, failure modes that can occur on a perfectly sealed container will be discussed along with how to determine if a CCIT failure is a true container leak or something else. Additionally, learn about the value of product-specific method qualifications to ensure the test method and fixturing are suitable for your product, as using a less-than-ideal test setup can lead to false failures.



Understanding of CCI test methodology and validation

Common failure modes that are not true leaks

Benefits of individual method qualification and cost


Packaging designers, engineers, quality assurance, quality control, design engineers, regulatory affairs, clinical, clinical research


Expert Technical Consultant
Nelson Labs


 has more than 25 years of medical device laboratory experience. She has worked in microbiology, bioburden, IDs, and packaging at Nelson Labs and has experience with various microbial tests, including microbial limits, plate counts, biological indicator population verifications, organism ID tests, and bioburden tests.


Laboratory Operations Manager
Nelson Labs


 holds a degree in microbiology and has most recently taking on the role of laboratory operations manager at Nelson Labs. He has worked in the sterilization, IDs, and packaging departments. Logan has extensive knowledge in the packaging section, as he has aided many customers with their package testing needs, from the benchtop to trouble shooting and validation design.


Webcasts

Tue, Sep 27, 2022 11:00 AM EDT

In this webinar, failure modes that can occur on a perfectly sealed container will be discussed along with how to determine if a CCIT failure is a true container leak or something else

Understanding Container Closure Integrity Test Failures

Videos

The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

Testing of the Packaging: Extractable Study Design and Challenges

Articles

Large volume parenteral applications are characterized by high volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. Definitions and regulatory requirements for extractables and leachables testing of large volume parenteral products, will be highlighted. Next, typical sources of extractables and leachables in flexible bag systems for parenteral use will be listed. Emphasis will be put on the specific challenges associated with large volume parenteral applications. Finally, some case studies regarding different designs of extractable studies will be discussed.



Webinar: Testing of the packaging: Extractable study design and challenges

When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), one of the obvious questions is How far should one go into the E&L-qualification process? As the drug product is in a solid state, one would expect that the interaction between the LDP and the components of its container would be low. But is this really the case? Watch this webinar to learn more.



Webinar: The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.

