Packaging and Transportation Validation

When packaging and transportation validation is required, Vosfox Medical can assist you in writing the protocol and organising the testing.  We can follow standards such as ISO 11607 or ASTM D-4169.

The Medical Device Directive states requirements for the packaging of Medical Devices.

  • Devices shall package so that their characteristics and performance during their intended use are not adversely affected during transport and storage.

  • Devices with a specific microbial state shall be packaged to ensure they remain in that state when placed on the market under transport and storage conditions.

  • The package shall ensure that it retains the sterile condition till the pack is broken.

Packaging Validation – Seal Integrity

When a product must be sterilised, the product must stay sterile after the sterilisation process. Therefore sterile barrier packaging is chosen and tested. The seals of pouches or blisters be of good quality. First, a visual inspection is done, checking for:

  • unsealed areas
  • non-homogeneous or undersealed areas
  • oversealed areas
  • narrow seals
  • channels
  • wrinkles, fold-overs or cracks
  • tears or pinholes

The Seal integrity tests are usually tensile testing. The minimum required seal strength as acceptance criteria are compared to the results of a set of samples.

Packaging Validation – packaging Integrity

There are several types of integrity testing. These tests look at the total package integrity, not just the seal. Common types of testing are

  • bubble leak testing
  • vacuum decay testing
  • dye ingress testing
  • burst testing.

The seal and packaging integrity must be tested over the period of the shelf life. The chosen tests are tested at time 0 and selected time points for accelerated and real-time testing.

Transportation Validation

The type of transportation testing depends on the risk that the product or packaging is damaged and the way of transportation. It is possible to perform drop or shake testing. Also, real-time transportation tests, using standard couriers, and sending parcels to the most unsure locations can be part of the validation testing.

It is also possible to use laboratory testing according to ASTM D4169, performing the following tests.

  • Drop Test
  • Vibration Test
  • Compression test/ Vehicle stacking
  • Altitude test
  • Climatic conditions test
  • Horizontal impact tests

With your regulatory specialist, we can discuss the necessary tests.