Automation Of Class III Medical Device Packaging

When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as it relates to Class III medical devices. If there is a breach of the seal, it affects the sterility of the device and may present a significant quality concern at a critical moment of use.

Class III medical devices are sterile components intended to be placed directly into the human body. A compromised package can act as a vehicle for microbial transmission and pose a significant risk to patient safety. Once bacteria or other contaminants find their way into the container, the device is no longer a treatment but instead is a threat to the patient.

Therefore, packaging and closure system of such containers must be up to the highest quality standards, as described by guidance documents. 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. While the USP document directly guides pharmaceutical practice, the standards must be applied for all combination devices. Additionally, the FDA develops best practices beginning with the high- risk parenteral marketplace, with standards and regulations often being applied to other high-risk applications such as Class III medical devices.

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 medical device manufacturers.