The packaging of medical products fulfils far more than just a logistical function – it is essential for maintaining product safety, sterility and user-friendliness throughout the entire life cycle. To fulfil these requirements, structured and standard-compliant packaging performance testing (PPT) is essential.

Regulatory requirements for packaging systems

Packaging systems for sterile medical devices must fulfil the requirements of ISO 11607-1 for successful market approval. This standard defines both the design requirements and the test methods for assessing the performance of packaging. A central component of performance testing is ASTM D4169, which provides standardised transport tests to simulate real distribution conditions.

Objectives and test methods

Medical devices are subject to mechanical and climatic stresses during storage, transport and handling – including shocks, vibrations and fluctuations in temperature and humidity. Packaging Performance Testing specifically tests packaging systems for these influences by means of

  • Climatic cycles (simulation of different climatic conditions)
  • Drop tests (simulation of impacts during handling),
  • Vibration tests (based on typical transport conditions),
  • Box Compression Tests (BCT) for load capacity testing during storage and stacking.

The aim is to identify weak points and derive targeted protective measures. The central evaluation criterion is the integrity of the sterile barrier system. This is verified using suitable integrity tests in accordance with ISO 11607-1 Annex B, such as the bubble emission test in accordance with ASTM F2096. The choice of method depends on the type of packaging, its transport conditions and distribution route.

Worst-case principle as the basis for testing

According to ISO 11607-1, performance testing must be carried out with the most critical packaging configuration within a product family – i.e. with the combination of sterile barrier and protective packaging that is most likely to fail under extreme conditions. The ‘worst case’ for sterilisation and sealing must also be considered. Such a worst-case scenario allows the test results to be transferred to similar products, provided this is documented and justified.

Test planning and documentation

A well-founded test plan requires an analysis of the transport and distribution conditions: individual packaging, shipping carton or pallet unit – the test conditions vary depending on the type of transport. The appropriate distribution cycle is selected in accordance with ASTM D4169, Table 1, which defines standardised test sequences.

Distribution cycle 13 (DC 13), which combines the requirements for air and road freight, is often selected for the international shipment of medical devices. In addition, climatic stresses must be simulated realistically to test packaging systems under different environmental conditions.

Conclusion

The safety and quality of medical devices depends significantly on a validated packaging system. Packaging performance tests in accordance with recognised standards provide a sound basis for minimising risks, meeting regulatory requirements and ensuring the integrity of the product right through to use. Manufacturers who invest in the planning and validation of their packaging at an early stage create an essential prerequisite for market success and patient safety.