Medical device packaging validation is a crucial part of the product development process, and at HIGHPOWER we work with our clients to ensure their device can pass each test in a healthcare setting. Strict adherence to medical device packaging standards are our top priority. HIGHPOWER’s medical device package testing methodology is based on methods outlined in ISO 11607, AAMI ST-77 and other American and International standards.
Packaging systems (rigid containers, sterilization pouches and sterilization wrap) which will be used to contain and sterilize reusable medical devices require validation in order to assure proper and efficacious reprocessing and length of shelf-life post processing. This is where the medical package validation testing and support at HIGHPOWER becomes incredibly valuable to your project, as we have been performing these tests for over 30 years.
HIGHPOWER simulates what a hospital environment would look like with decontamination, sterilization and storage areas for all packaging validation studies. We can perform various medical device package integrity tests and account for any possible real-world situation/worst-case testing conditions. If you do not have an existing design to test, we can even provide assistance in creating one.
We’re constantly adding new medical device packaging validation tests to meet our customer’s expectations. If you don’t see your required test listed, please contact us at clientservices@highpowervtls.com with your inquiry.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| AC-STERRAD | STERRAD Whole Package Integrity Test (Aerosol Challenge Test) |
| AC-ETO | EO Gas Whole Package Integrity Test (Aerosol Challenge Test) |
| AC-STEAM | Steam Whole Package Integrity Test (Aerosol Challenge Test) |
| AC-VPRO | V-PRO® Whole Package Integrity Test (Aerosol Challenge Test) |
| BE-ISO | Bubble Emission (ASTM F2096) BT-ISO Burst Test (ASTM F1140) |
| DM-ISO | Dye Migration (ASTM F1929) |
| SL-ACCEL | Accelerated Aging Shelf-Life Study (ASTM F1980) |
| SL-ETO | ETO Real Time Shelf-Life Study for: 30 days, 90 days, 180 days, 365 days or 2 years |
| SL-STEAM | Steam Real Time Shelf-Life Study for: 30 days, 90 days, 180 days, 365 days or 2 years |
| SL-STERRAD | STERRAD Real Time Shelf-Life Study for: 30 days, 90 days, 180 days, 365 days or 2 years |
| SL-VPRO | V-PRO® Real Time Shelf-Life Study for: 30 days, 90 days, 180 days, 365 days or 2 years |
| SL-SZ STERIZONE® | Real Time Shelf-Life Study for: 30 days, 90 days, 180 days, 365 days or 2 years |
| SP-ISO | Seal Peel (ASTM F88) |
| AC-SZ | STERIZONE Whole Package Integrity Test (Aerosol Challenge Test) |
| BFE | Bacterial Filtration Efficiently (ASTM F2101) |