Lifecycle Planning

It can take more than 12 years and a major financial investment to bring a drug product to market.1 A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of  patient adherence. The importance of container closure and delivery [...]

Quality Solutions Mitigate Total Cost of Ownership

In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership. There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can [...]

Testing for Container Closure Integrity Using Helium Leak Testing

Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity. In practice, there are numerous [...]

Vacuum Retention in Vial-Stopper Systems: A Study on Component Compatibility

Jeff Smythe, Lynn Lundy, and Amy Miller The pharmaceutical industry faces challenges when choosing packaging components for lyophilized products. The European Commission Guide to Good Manufacturing Practice, Annex 1, Section 89 states, “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period.” Selecting optimal components for the lyophilization [...]