Managing Container Closure Related Complexities With Lyophilized Drug Products

The complexities of pharmaceutical drugs begin with development of the molecules and extend through the manufacturing processes and final delivery to patients. Optimal functional performance of these systems relies on predictable and consistent chemical, physical and performance properties. Chemical and physical properties of a container closure system for parenterals may affect the drug manufacturing process, product quality and patient safety.

The potential impact of elastomeric components on product quality and patient safety is well established and addressed by a variety of compendia chapters and regulatory guidance documents. Assessment of Extractables & Leachables, Container Closure Integrity and functional performance are a common part of assessing suitability for intended use of container closure systems.

Design for manufacturability on the other hand, is not as well established and may frequently be an afterthought. In the case of a lyophilized product, significant and additional risks are associated with design for manufacturability and the resulting impact on product quality. Lyophilization stoppers are unique in the fact that they are an integral part of the manufacturing process of a lyophilized drug product. Selection of container closures with optimal design and physical properties can reduce downtime, improve lyophilization performance and overall improve throughput and yields.

Using a comprehensive approach to component selection, ideally early in the drug development process, mitigates risks to fill-finish and lyo processing. The increasing focus on optimal performance of the components and contamination control strategies as part of the manufacturing process does not require compromises to product quality and patient safety. With careful and deliberate selection of container closures, there does not need to be a trade-off between manufacturability, and product quality and patient safety. This webinar explores key considerations for selecting lyophilization stoppers suitable for intended use.

Key Learning Objectives:

• Recognize packaging features that influence lyophilization process performance and manufacturability
• Understand the impact of stopper design and elastomer formulation when choosing primary packaging
• Address shared challenges faced when selecting primary packaging components for lyophilized drugs
• Learn about the complexities of freeze-drying, and the interrelationships of product formulation and packaging