ABSTRACT
The assurance of patient safety requires that all parenteral product packaging prevent the ingress of microbial contaminants. While this is certainly critical, it can be said from a broader perspective that package integrity is the measure of a package’s ability to keep the product in and to keep potential contaminants out. The “product” necessitating containment is typically thought of as either the formulated liquid or the solid drug product inside the package. But the product may also include the gas headspace environment within the package. Such is the case for products requiring the maintenance of a rarefied gas headspace or a partial pressure environment to ensure either the product’s stability or the package’s functionality. And while parenteral packaging must prevent potential microbial contamination, it must also prevent the ingress of unwanted environmental debris, chemicals, or particulates.
