Validation of a sterilization dose for products manufactured using a 3D printer

As more healthcare products are personalized, the use of unique, patient-specific products will increase. Some of these are manufactured using a 3D printing process (also known as additive manufacturing) for either polymers or metals. For these products, processes such as sterilization validations must be handled in a different manner. The concepts typically used are still relevant but are approached from an alternative perspective to account for a potential production batch size of one, and for the great variability that can occur in size and shape of a product.