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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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By Bettine Boltres

November 11, 2020

Understanding the different compendial and standards requirements, and how they influence the final delivery of parenteral drug products, is critical for ensuring patient safety. There are ongoing efforts to harmonize national pharmacopoeia and international standards, driven in large measure by the continuous technological developments in the pharmaceutical industry. Harmonization efforts can be treated differently depending upon the country and working group, and in some cases larger differences result. Staying aware of changes and differences can be a challenge.

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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