The implementation of ISO 19227:2018, which addresses the cleanliness of orthopedic implants, has set a new standard in evaluating residual levels after the final manufacturing process. This has become a regular expectation from both OEM customers and regulatory bodies. While this standard outlines the general requirements for implant cleanliness, developing a test strategy based on the specific use of the device remains a challenge for many manufacturers.
This webinar will provide a detailed overview of cleaning validations for newly manufactured orthopedic implants, as well as considerations for devices outside the scope of ISO 19227. The session will guide participants through the entire cleaning validation process, from identifying potential contaminants to developing a test strategy and evaluating the results.
We will begin by exploring the importance of identifying potential contaminants that could affect the cleanliness and safety of orthopedic implants. It is crucial to understand the sources and types of contaminants that might be present after the final manufacturing process to design an effective cleaning validation plan. Attendees will learn about the different contaminants and how to accurately identify them.
The webinar will then delve into developing a test strategy tailored to the device’s specific use. This includes selecting appropriate testing methods and protocols to evaluate the cleaning process’s effectiveness. Practical guidance will be provided on designing a test strategy that meets regulatory requirements and ensures the highest cleanliness standards for orthopedic implants.
Finally, the session will cover evaluating test results, offering insights into interpreting data and making informed decisions based on the findings. Participants will learn how to assess whether the cleaning process meets the required standards and how to document and report the results effectively.
This webinar is essential for professionals involved in manufacturing, quality assurance, and regulatory compliance of orthopedic implants. By attending, participants will gain valuable knowledge and tools to develop and implement robust cleaning validation plans, ensuring their products meet the stringent cleanliness requirements set by ISO 19227:2018 and other relevant standards.