Mitigate Risk With Package Quality

In the life sciences industry, quality is the drumbeat for profitability. Most quality initiatives are passive and driven by organizational jargon. How about real progressive change for once? Package testing and container closure integrity are cornerstones for quality. Without a quality package, there is no product. In fact, a bad package is a serious liability. Product that may be assumed good will fall short of enduse requirements, will be exposed to contaminants, and is a common cause for regulatory action. When developing new products, clarity around package quality control can better define the process requirements and set the stage for successful product launch and profitability throughout the product life cycle.

Now more than ever, innovative package designs are being used to differentiate and simplify pharmaceutical product delivery and end use. With new designs come new challenges to validate package stability and performance. A product development team must understand very clearly what level of package failure is critical to the quality of the product over the duration of the product’s shelf life. Key questions to ask include, “At what point does my package stop working?” “At what point does my barrier fail to fulfill its purpose?”

When assuring package quality, you must understand what quality actually means for your package system and product. Quality is often defined as whether or not the package has maintained a sterile barrier or has been breached.

Answer these two guiding questions when defining package quality for your specific application. (1) What is critical to the quality of the product? (2) What is critical to the package and delivery system that may affect the quality of the product? For a parenteral closure system it can be quite simple — leaks below 10 micrometers in diameter still pose a significant risk to product sterility. For medical devices the answer is far more complex. A balance of risk assessment and best-available technology usually prevails when defining quality.