Nelson Labs

Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety.

Webinar Date/Time: Wed, Mar 6, 2024 2:00 PM EST

Implementing a proper contamination control strategy (CCS) helps ensure product quality and patient safety. Additionally, it is a core element of good manufacturing practices.

Nelson Labs offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.

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

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.

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.

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.

***Thursday, May 20, 2021, 2pm EDT | 1pm CDT | 11am PDT*** Flexible bag systems used for large-volume parenteral drug applications contain different materials that pose potential sources of contamination. In this webcast, learn about the sources of extractables and leachable, testing programs, regulatory requirements, and challenges specific to large-volume parenteral applications. *** On demand available after final airing until May 20, 2022.***

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

Would you like to learn more about the E&L qualification process of the primary packaging for lyophilized drug products? Then make sure to attend this 45-minute webinar, given by Piet Christiaens scientific director at Nelson Labs Europe. Live: Thursday, Oct. 15, 2020 at 2pm EDT| 1pm CDT| 11am PDT On demand available after final airing until Oct. 15, 2021

For drug-device combination products, the compatibility of the drug and device components requires analysis of many factors. In this webcast, learn about regulations and drug-device compatibility assessment steps that are necessary to protect patients. Live: Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until May 19, 2021.