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“Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA”.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.
Our simulated central service departments’ decontamination, sterilization and storage areas will be used in packaging validation studies whether we are performing maintenance of packaging integrity (MPI), whole package integrity test or real time and/or accelerated shelf life testing.
With over 25 years of experience validating medical device packaging systems, our dedicated staff will use proven protocols to validate that your product can maintain the sterility of processed medical devices till point of use.
With every major FDA cleared sterilization process in-house (steam, ETO, hydrogen peroxide, peracetic acid, dry heat and chemical vapor), our scientists and technicians can assist device manufacturers in all of their packaging and package integrity validation needs.
- Accelerated Aging
- Real Time Shelf Life
- Whole Package Integrity Test
- Aerosol Challenge
- Dye Migration
- Burst Test
- Bubble Emission
- Seal Peel
We’re constantly adding new test to meet our customer’s expectations. If you don’t see your required packaging system test listed, please contact us at firstname.lastname@example.org with your inquiry.