Pharmaceutical & Medical Packaging

Impact Resistance as a Sterility Barrier

In pharmaceutical and medical packaging, the flexible film or laminate is part of the sterile barrier system (SBS). For IV fluid bags, dialysis bags, and Tyvek-based sterilization pouches, any micro-crack or pinhole induced by impact during transport, storage, or hospital handling can compromise sterility and put patients at risk.

Dart impact testing according to ASTM D1709 / ISO 7765-1 gives a quantitative measure of how much energy the film can withstand before failing. Combined with seal-strength and dye-penetration tests, it forms an important part of validation studies under standards like ISO 11607-1/2 and general requirements such as YBB 00132002 for pharmaceutical laminated films and bags.

Alignment with YBB and International Standards

YBB 00132002 defines general requirements for laminated films and products used for pharmaceutical packaging, including composite IV and drug sachet films with typical thicknesses below 0.25 mm. The MLB-01 is used to perform impact tests on these flexible laminates using the ASTM D1709 / ISO 7765-1 free-falling dart method, which is widely accepted by international clients and auditors.

To support regulated environments:

1. Traceable data management: The MLB-01 supports user login and can store up to 200 result groups with sample ID, operator, date/time, method, and dart mass. Data can be printed immediately and exported via USB for integration into GMP documentation systems.

2. Consistency via zero-magnetism release: Unlike electromagnetic testers, which can suffer from residual magnetism and inconsistent release of light darts, KHT’s 3-jaw pneumatic gripper holds and releases the dart mechanically. This ensures clean, vertical drops with minimal initial rotation—critical for reproducible tests on thin, sensitive medical films.

Typical Pharma & Medical Use Cases

- IV and dialysis bags: Impact resistance evaluation of multilayer films used for large-volume parenterals to ensure they withstand handling and transport shocks.

- Tyvek-based sterilization pouches: Verification that the laminate structure and seal areas can resist incidental impact without compromising SBS integrity.

- Drug sachets and diagnostic pouches: Testing small-format laminated films used for powders, granules, and test kits, where puncture can lead to contamination or leakage.