By Oliver Stauffer and Michelle Wolf
Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure integrity.
When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as related to parenteral pharmaceuticals. If there is a breach of the seal, even a microscopic one, it affects the sterility and the stability of the product – the drug may not be as effective due to oxidation or moisture ingress impacting the active ingredient.
But more importantly, a defect in the seal can lead to patient safety concerns. Parenterals are sterile preparations intended to be administered directly into the systemic circulation in humans or animals (think solutions, suspensions, and powders for injection, infusion, or implants). A compromised parenteral container can act as a vehicle for microbial transmission and pose a significant risk to patient safety. Once bacteria find their way into the container, the drug is no longer a treatment but instead is a threat to the patient.
Therefore, packaging and closure of such containers must be up to high quality standards, as described by pharmacopeias. For example, the United States Pharmacopeia (USP) chapter 1207 “Package Integrity Evaluation—Sterile Products” provides guidance that emphasizes the importance of using reliable and sensitive methods for CCI testing and sets out recommendations on developing and validating a compliant CCI test.
This article will explore the need for sensitive and fast automated CCI testing technologies that are also reliable and how existing solutions can help achieve optimum quality goals for pharmaceutical manufacturers.