Medical packaging validating
Quest’s quality process includes validating these test methods per ISO 11607 prior to testing your products.These requirements are put in place to ensure that medical device packaging systems remain sterile and provide physical protection to the medical device until the point of use.The integrity of terminally sterilized medical device packaging is crucial to maintaining sterility of the devices.For example, a bubble emission test or dye penetration test, among a variety of other tests, can be used to test the integrity of the package seals of medical packaging.By keeping bacteria and other impurities away from the contents, packaging plays an important role in ultimately delivering treatment to patients successfully.Don’t choose a manufacturing partner that can’t deliver a finished, packaged product that’s ready for the shelf.
Remanufacturer Remanufacturers rebuild products to OEM specifications by using a combination of used, repaired and new parts.
These can include variations for different materials and test methods unique to your packaging and your specific requirements.
These tests can be performed following ASTM D4169 shipping simulation tests, ASTM F1980 simulated aging tests, or as separate stand-alone activities.
HIGHPOWER’s test methodology is based on methods outlined in ISO 11607, AAMI ST-77 and the FDA guidance document “Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA”.
Packaging systems (rigid containers, sterilization pouches and sterilization wrappers) which will be used to contain and sterilize reusable medical devices require validation in order to assure proper and safe reprocessing by health care personnel.