Package Testing

Tests on finished packages are mainly conducted in the OQ and PQ portions of a packaging validation. Typical tests include burst testing, seal strength testing and integrity testing.

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Simulated Distribution Testing

Simulated Distribution Testing is performed on sterilized packaging to validate a packaging system, usually in the Operational Qualification (OQ).

Defect Analysis

Should there be any failures in the package integrity test, it is important to perform defect analysis.

Corrugated Shippers

Inspection and rating of corrugated shippers is performed after the simulated distribution regimen.

Burst Strength

Burst strength is a multi-directional tensile test that may be used to test the strength of a package by filling the package with air until it bursts and then measuring the terminal pressure.

Aging and Expiry Dating

Real-time aging must be done followed by package integrity testing to show that the contents of the package remained sterile.

Package Integrity Tests

Packages may be tested for integrity (holes, channel seal leaks, open seals) by inserting a Toluidine Blue Dye solution with a specific viscosity.

Folding Cartons

Inspection and rating of folding cartons is performed after the simulated distribution regimen.

Seal Strength

Seal strength of medical packages is measured using a strain gauge test instrument such as an Instron® testing system or a Chatillon® gauge or testing instrument.

Peel Open Evaluation

Peel Open Evaluation is done on primary packages (sterile packages containing medical devices) to be sure they are suitable for aseptic presentation.

Microscopy

Microscopy plays a significant role in defect analysis. Knowing whether a failure was caused by a puncture, abrasion or flexing can help in determining the assignable cause and can form the basis for corrective action.