Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These levels serve as critical control points to ensure the cleanliness and safety of medical devices during production. Although standards often include guidance, they allow for flexibility and do not provide detailed directions. This webinar will cover common practices in the medical device industry for setting these levels and the different types of alert and action levels. Understanding the various approaches is crucial, as some methods are more suitable for specific applications than others.
This presentation will provide a foundational understanding of setting alert and action levels, including some common suggestions for handling bioburden excursions. We will discuss the rationale behind different levels, how to determine appropriate thresholds, and the implications of exceeding these limits. Participants will learn about the role of environmental monitoring in maintaining product quality and the significance of responding to bioburden excursions promptly.
By the end of this session, attendees will have the knowledge to establish effective alert and action levels, ensuring their products meet regulatory requirements and maintain high standards of safety and efficacy.