A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity
In the upcoming 2022 Nelson Labs Virtual Symposium, this presentation will emphasize the importance of selecting materials...
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On the Origin of Extractable Species
The universe of extractables is extremely diverse, encompassing a wide variety of materials used in the construction...
Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
Assessing the Safety of Extractables and Leachables for Drug Products: When and How?
In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety...
The Design and Qualification Process for a LVP Packaging System from a User Perspective
To meet the growing patient need for Large Volume Parenterals (LVP), increasingly complex packaging systems must be...
LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements
Large Volume Parenterals (LVPs) can be packaged in a variety of formats made from polyolefins, including pouches,...
Challenges and Considerations for Complex LVP Drug Products
Addressing the toxicological risks associated with patient exposure to leachables requires a strategy tailored to the unique...
The Production Process and Qualification of a Pharmaceutical Film
What is required to qualify primary packaging materials for Large Volume Parenterals (LVPs)? What factors should be...
An introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form
Pharmaceutical dosage forms are primarily distinguished by their route of administration, with secondary differentiation based on other...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...