How Dart Impact Testing Supports YBB Requirements for Pharmaceutical Laminated Films

How Dart Impact Testing Supports YBB Requirements for Pharmaceutical Laminated Films

Pharmaceutical laminated films used for IV bags, infusion solutions, and drug sachets must meet strict regulatory and quality requirements. In China, YBB standards define general requirements for laminated films and bags used in drug packaging. While these documents may not spell out a single mandatory impact test method, dart impact testing according to ASTM D1709 or ISO 7765-1 is widely recognized as a relevant way to evaluate mechanical robustness.

In practice, laminated films for pharmaceutical use often consist of multiple layers: sealing layers, barrier layers, and structural layers. Weakness in any of these layers can lead to cracks or pinholes under impact, especially when filled products are dropped during transport or handled in hospital environments. Dart impact testing subjects the laminate to localized, dynamic loading that mimics real-life events. By quantifying the failure mass (M50), it gives a numerical measure of the laminate’s ability to resist such events.

To use dart impact testing meaningfully in a YBB context, the first step is to clearly define test conditions. These should include film type, thickness, conditioning temperature, and test method (A or B). For thin IV bag and sachet films, Method A is generally appropriate. For more robust structures within the standard thickness scope, Method B can be considered. The chosen conditions should be documented in validation protocols and related quality agreements.

During validation, dart impact results can be combined with other tests that YBB documents highlight, such as tensile strength, seal integrity, and barrier properties. The aim is not to treat impact in isolation, but to show that the film performs reliably in all relevant aspects. For example, a validation report may show that a laminate meets YBB requirements for appearance and barrier, and also achieves an M50 higher than a defined threshold under specified dart impact conditions.

For ongoing production, dart impact testing can be integrated into routine QC for pharmaceutical laminates. Batches that fall below the established M50 limit may be flagged for further investigation before being converted into bags or pouches. Over time, correlating M50 values with field performance and complaint data allows manufacturers to refine their specifications. This systematic approach supports both YBB compliance and international expectations for robustness of drug packaging materials.