New Elastomeric Formulation and the Relevance of Quality by Design in Primary Packaging
Sascha Karhöfer, Director Global ICS Platform at West, presented “New Elastomeric Formulation and Relevance of Quality by Design (QbD) in Primary Packaging” on March 19, 2013, at Pharma-Kongress: Production and Technique in Dusseldorf, Germany.
The discussion focused on:
§ Market requirements for primary packaging systems
§ New generation elastomeric materials for parenteral applications
§ Implementation of QbD principles in primary packaging
§ Benefits of using QbD for primary packaging systems
West designed its NovaPure® components using QbD principles. NovaPure components can help customers meet current quality requirements for finished pharmaceuticals and achieve consistent specifications for subvisible particles in finished drug products. NovaPure components are manufactured to uniformly high quality levels with a subvisible particle specification and a product-specific parts per million critical defects specification. Components are delivered with full documentation, including expected extractables compared to a reference chromatogram to assure closure consistency of the highest level.
For more information about NovaPure components, click here.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.