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West’s Paul Cummings, Regional Director, Analytical Services, will present “Container Closure Integrity Testing of Glass and Polymer Containers from Ambient Temperature to -80°C” at the 2013 American Association of Pharmaceutical Scientists Annual Meeting and Exposition on November 10-14, 2013, in San Antonio, Texas.
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/
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled <a href="https://www.youtube.com/watch?v=5K8R1jumXyU&feature=youtu.be">Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution</a>, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.
Vial-based primary packaging systems for sterile drug products must provide protection over shelf life. This requires demonstration of container closure integrity (CCI); this testing should be performed early in the drug product development stage. As we all know, there is not one CCI test method that fits all systems/conditions.
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
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