Assessing extractables and leachables is important for patient safety and to calculate any potential impact on the process and product. Therefore, Smithers recommends that an extractables and leachables risk assessment should be created for your biopharmaceutical manufacturing processes. When creating an assessment the following factors should be considered:
Making the right choices about where and how leachable assessments of SUS are performed can significantly affect timelines, testing costs and minimise impact of future materials changes (unfortunately they do happen). Smithers works with customers to find the best strategy that meets their needs.