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 [...]

Selecting the Proper Elastomeric Formula

Because your drug product has direct contact with the container closure system (vial and stopper), it is critical to consider compatibility factors of the rubber formula when selecting a stopper for your drug package. It is possible for a drug product to become contaminated if the drug and components react chemically. The substances that may [...]

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 [...]

An Alternative to Current Sterilized Plungers for Glass Syringes

The use of steam has been the preferred technique to sterilize components for sterile parenteral applications.  Steam is the most common method of sterilization for vial stoppers and related components.  However, in the case of plungers for prefillable applications, gamma irradiation has been the historic standard throughout the industry for sterilization of the elastomeric components, [...]