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Paul will discuss the preservation of container closure integrity of a parenteral drug product which is critical over the shelf life of the product. Alternatives to sterility testing include properly validated container closure integrity (CCI) physical tests. Methods other than sterility testing can be employed to confirm container and closure system integrity as a part of the stability protocol for sterile parenteral pharmaceutical products. With an increasing number of parenteral biologics available and the trend toward low temperature storage conditions of such sensitive products, it is essential to evaluate container-closure integrity testing of these products at sub-ambient temperatures.
The discussion will present an overview of the investigation of helium leak detection as a means of testing container closure integrity when stored at -80°C. Standard 5-mL glass vials with several configurations of elastomer stoppers were assessed throughout the study. Some of the elastomer stoppers on the 5-mL glass vials were configured to ensure positive controls.
Vials were assessed at different time points throughout the study to evaluate the effectiveness of the current storage methodology. The results of the investigation, the challenges encountered and potential future studies will be presented at AAPS.
To register to attend the AAPS event, visit:http://www.aaps.org/Meetings_and_Professional_Development/Calendar/2013/2013_AAPS_Annual_Meeting_and_Exposition/