Validation of the Sealing Machine Process for Surgical Packs

A manufacturing plant in Tijuana focused on providing medical device solutions to improve the quality of life of patients. The company has developed thanks to its innovative products in the market considerably. As a business strategy at the corporate level, opportunities were detected and involved the transfer of the manufacturing of products to different facilities in Mexico. In order to manufacture a product that complies with standards to ensure the sterile barrier standards to ensure sterilization barrier of the product, this project consists of validating the Max Tray Sealer machine of the kit kat two production lines. The validations process covers all the quality system requirements governed under the ISO-13485 standards, which define the validation stages. The stages of the validation include the installation qualification, the operational qualification, and the performance qualification.