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As drug manufacturers aim for higher safety standards and enhanced patient care, controlling the drug product at the point-of-use in a hospital or clinical environment remains a significant challenge. The method of vial access often varies, increasing the risk of adverse patient outcomes, such as stopper cores or fragments entering the drug product. If injected, these fragments can lead to cardiovascular events and other complications. Several factors contribute to stopper coring and fragmentation in the field, primarily influenced by the technique of the practitioner and the properties of the elastomeric closure.

Sanjeev Seenath

July 09, 2025

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Previous Blogs

West Presented on China Registrations for Combination Products at Annual ISPE Meeting & Expo

By Katie Casale

January 06, 2021

On November 6, 2020, West’s Regulatory Affairs Senior Director, Lynn Lundy, presented at the 2020 ISPE (International Society for Pharmaceutical Engineering) Annual Meeting and Expo. The week-long virtual meeting focused on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry. Pharmaceutical and biopharmaceutical professionals from drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies were in attendance to discuss hot topics such as Data Integrity, Covid-19 Impact, Combination Products and more.

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Films and Coatings

Pharmaceutical Packaging Components

Prefillable Systems

Self Injection Devices

Vial Containment Solutions

Washing and Sterilization

Reconstitution and Transfer Devices

Select a sub-category to view results

Analytical Lab Services

Contract Manufacturing

Fill-Finish

Regulatory Support

Select a sub-category to view results

Cell and Gene Therapy Packaging

Drug Development Process

Regulatory Challenges

Transitioning to Combination Products

Select a sub-category to view results

Corporate Development

ESG/Sustainability

One West Team (Employee Culture)

Our Culture of Giving (Philanthropy)

Research and Development