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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:
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.
Although Corporate Responsibility is often most thought of as caring for the environment and giving back to local communities, we firmly believe that it also means taking responsibility for the health and safety of our team members, contractors and visitors, and working to safeguard them against work-related accidents and illnesses. It is West’s policy to comply with all applicable health and safety laws and regulations, and we are committed to designing and operating our facilities to provide a healthy and safe workplace.
The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
I am the Production Manager at our Waterford manufacturing site in Ireland. I have worked at West since 2018 and was the Area Manager for Waterford’s Finishing Department until I was promoted in November 2022.
The global prefilled syringe market is growing rapidly, and approximately 60% of prefilled syringes use staked needles. To help ensure the integrity of the drug products contained within, the majority of staked-needle prefilled syringes use Rigid Needle Shields (RNS).
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
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