Blogs

Categories

Select a sub-category to view results

Icon
Films and Coatings
vail 4ml
Pharmaceutical Packaging Components
Icon
Prefillable Systems
Icon
Self Injection Devices
Icon
Vial Containment Solutions
Icon
Washing and Sterilization
Icon
Reconstitution and Transfer Devices

Select a sub-category to view results

Icon
Analytical Lab Services
Icon
Contract Manufacturing
Icon
Fill-Finish
Icon
Regulatory Support

Select a sub-category to view results

Icon
Cell and Gene Therapy Packaging
Icon
Drug Development Process
Icon
Regulatory Challenges
Icon
Transitioning to Combination Products

Select a sub-category to view results

Icon
Corporate Development
Icon
ESG/Sustainability
Icon
One West Team (Employee Culture)
Icon
Our Culture of Giving (Philanthropy)
Icon
Research and Development

Previous Blogs

Extractables and Leachable Testing

By Amy Miller

June 12, 2020

The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”

Helium Leak Testing

By Bettine Boltres Ph.D.

December 05, 2018

In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.