Packaging Validation Required for Medical Blister Packaging

According to ISO 11607 and related regulatory standards, medical blister packaging must undergo rigorous testing to ensure compliance. These tests cover aspects such as biocompatibility, physicochemical properties, sterilization compatibility, heat-sealing performance with lid materials, and transportation simulation. A complete medical packaging validation plan includes, but is not limited to, the following tests:

1.Microbial Barrier Test

2.Toxicological Testing

3.Peel Strength Test

4.Leak Test

5.Bioburden and Particulate Testing

6.Aging Test

7.Sterilization Residue and Sterility Testing

8.Stacking and Transportation Simulation Testing

These tests ensure the safety, reliability, and compliance of medical blister trays throughout their lifecycle.