Symposium will explain specific challenges of an extractables and leachables qualification program for large volume parenterals
Salt Lake City, UT – August 28, 2020 – In Q4 of 2020, Nelson Labs will host a (virtual) Symposium regarding the different challenges a user of Large Volume Parenteral Container/Closure Systems can face. More details will become available later this year but interested participants can sign up in the form below to receive updates on the symposium.
In the qualification process of Large Volume Parenteral (LVP) Container/Closure systems from an Extractable & Leachable perspective, a traditional E&L approach quickly faces a substantial number of challenges that are typical for this type of dosage form. Because higher volumes are administered to a patient – these volumes could be as high as a few liters per day – it is clear that with the currently required AET levels, the qualification of E&L compounds will need to be performed at much lower concentration levels, both in the extracts of the different components (in extractable studies) as well as in the drug product (leachable studies).
The symposium will give a helicopter view of all problems one can encounter in an LVP-qualification process, such as:
- Understanding the materials, their function and composition, used in LVP-manufacturing
- E&L studies, specifically designed to support Large Volume Parenteral Applications
- The necessity to adjust the analytical instrumentation and methodologies to address some of the challenges in LVP quantifications.
- The complexity of performing leachable studies on drug products that may be complex in their composition (nutrition solutions, blood derivatives, emulsions, etc.)
- The higher need to identify compounds at low concentration levels
- The subsequent need for more in-depth toxicological testing of the discovered leachables
- Risk assessment of the discovered, identified, and quantified leachables: How extensive can it get?
- How a simulation study can address certain challenges encountered with LVP containers
- And more…
The intent of this symposium is to create an open dialogue and interactive discussion with all stakeholders in the LVP value chain where science, ideas, and experiences could be shared.
- Pharmaceutical companies, using LVP containers as a container/closure system
- LVP component manufacturers (Films, tubing, rubber products, etc.)
- Raw material manufacturers for components used in LVP container/closure systems
- Pharmaceutical packaging and device engineers
- Production engineers, using SU systems
- Regulatory Affairs officers
- Pharmaceutical R & D managers
- Analytical chemists, working on E&L
- Quality Assurance officers
This FREE event is not currently scheduled. However, we are currently working on finding the best possible date. If you would like to be informed as soon as we have a date firmly scheduled, please provide your contact information below: