Transportation studies, or shipping validations, may be performed independently from the stability studies, or they may be incorporated with the stability studies to best represent the actual use cases of the product.

Specific Types of Equipment

Most companies outsource shipping validation activities, as they require specific types of equipment.

Most of the time, transportation studies are done in accordance with ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems”, although ISTA 3 series may be used, the preference from the FDA has been the ASTM D4169.

The procedure involves:

• Defining the shipping unit in terms of size, weight and construction
• Establishing the assurance level that is desired
• Determining the acceptance criteria as it relates to the desired condition of the shipper, packaging, and product at the end of the shipment cycle
• Determining the sample size based on the desired confidence and reliability
• Selecting the appropriate distribution cycle which best correlates with the intended distribution
• Writing the test protocol
• Selecting the samples for test
• Conditioning the samples
• Performing the tests
• Evaluating and documenting the results

Click on the link below to learn more about this course.