Packaging validation arises from the need to guarantee the safety of goods during all the processes that make up the distribution cycle: from transport to storage. This is a particularly important need for certain types of products, with the packaging test standards for the medical and pharmaceutical industry standing out in particular. 

In this context, packaging validation involves the identification and control of materials and processes that may affect the protective capacity of the packaging and the properties of the cargo it contains. 

Thus, compliance with shipping test standards makes it possible to study the packaging at three levels: 

  • Prospective: the analysis takes place before the product is placed on the market.
  • Concurrent: it is done before the product is distributed, but assuming it will be done.
  • Retrospective: it takes place after the package has been distributed, monitoring the protective capacity of the packaging. 

Among the advantages of carrying out a validation process of the appropriate packaging, we can mention:

  • Process control, both at the level of packaging design and distribution cycles.
  • Economic benefits, since the packaging is validated before going out to circulation, so the losses due to shrinkage are lower, as well as complaints from the end user, who receives the product in perfect condition. 


Packaging test standards

Packaging validation must be carried out by professionals who understand and have the necessary knowledge to apply packaging test standards. 

This is the reason why shipping test standards appeared, which allow companies to certify that their product-packaging system is ready to go through the distribution cycle without running risks. 

ISTA packaging standards

ISTA (International Safe Transport Association) is the organization focused on solving the needs of safe freight transport. It is the main generator of test protocols for packaging validation, which has been creating test methods since 1948.

ISTA packaging standards are divided into 7 series, and some of the most relevant include ISTA 6-AMAZON.COM-SIOC and 6-AMAZON.COM-Over Boxing, for distribution through the e-commerce giant Amazon. 

Amazon suppliers must meet the above standards to be certified under the Frustration-Free Packaging program and continue to sell through their supply chain.  

ASTM Standards

ASTM is one of the largest volunteer-generated standards organizations around the globe. ASTM standards represent the consensus of producers, consumers, governments and researchers from more than 140 countries for the application of quality standards.

Among the packaging test standards, the following stand out: ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems, and ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Parcel Delivery System.


Packaging validation in the medical context

Packaging test standards are particularly important in the transport of goods from the medical and pharmaceutical industry

In this sense, the packaging must ensure that the goods are free from contamination by external agents, that they do not allow the development of microbes and that the guidelines for keeping the product safe are respected. 

Because some processes during the distribution cycle can endanger the stability of the product, it is necessary to carry out rigorous tests to test the packaging. 

That is why there is the ISO 11607-1 protocol, which includes: 

  • A sterile barrier system, defined as “the minimum packaging that prevents the entry of microorganisms and allows the sterile presentation of the product in the place of use”.
  • Protective packaging, defined as a “material configuration designed to prevent damage to the sterile barrier system and its contents from the time they are assembled until they are used”.
  • Packaging system, which is a “combination of the sterile barrier system and the protective packaging”.

The ISO 11607-1 protocol describes how to carry out packaging validation, which tests the product-packaging system in situations similar to those in the distribution environment. 

Among the tests included in the shipping test standards, the following tests stand out:

After the tests have been carried out, a visual inspection is carried out to verify that the product has not suffered any damage and, therefore, to confirm packaging validation. If this is not the case, the pertinent actions will be carried out to improve and optimize the packaging, so as to guarantee its viability and safety. 


Would you like to know more about packaging validation, shipping test standards and how your company can access it? At Safe Load Testing Technologies, we put our experience and know-how in the packaging industry and transport simulation at your disposal.

Contact us and we’ll help you meet packaging test standards and access all the benefits of optimized packaging. 

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