The importance of medical device packaging should not be underestimated – the product being delivered to the consumers safe and sound depends on it. Performing the necessary tests and complying with the requirements is essential, which is why the medical packaging design should be taken into account since the very start of the product development process. 


Medical device packaging requirements

Complying with packaging requirements is the responsibility of the medical device manufacturer. This is the only way to guarantee that the products will be protected during transportation, and that they comply with health and safety regulations. 

Pharmaceutical and medical products have certain special characteristics (such as their limited shelf life). For this reason, their requirements for transportation and commercialization must be aligned with them. 

The protocols aimed at guaranteeing their safety focus on factors such as the seal integrity, materials or how the package reacts to the passage of time. 

At a government level, the most important regulations are those of the Food & Drug Administration (FDA) in the United States, and the Medical Devices Directive in the European Union. 

Medical device packaging doesn’t just need to arrive at the hospital, clinic, or end customer free from holes, tears or missing seals; it must also withstand the passage of time in storage, where it must be able to remain for years without the drug or device having their composition altered. 

Some of the medical device packaging protocols include:

  • ISO 11607 Packaging for terminally sterilized medical devices.
  • EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods.
  • ASTM D1585 Guide for Integrity Testing of Porous Medical Packages.
  • ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products.
  • ASTM F3475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.
  • BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
  • ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market.
  • ISO 11137, which measures Gamma and E-beam sterilization.

Before performing any of these tests, one must ensure that the package is sterile, so that protocols are performed on a product that is exactly in the same condition as that of the product to be commercialized. 


Testing processes for medical packaging design

Protocol ISO 11607 outlines the key aspects of pharma and medical device package testing. 

On one hand, it describes the key aspects of testing medical device packaging, including the classification of the material, testing the sealing process and the integrity of the seals of the entire package. On the other, it includes the physical tests to be performed, which include burst, deformation, strain to failure, detachment and leak testing.

Finally, transport simulations are also required, so as to test the package’s resistance and ability to protect the goods from the hazards of the distribution cycle. 

In summary, transport testing involves three types of tests: 

1. ISTA 1 Series. Integrity performance tests without simulation to test the resistance and strength of the product-packaging combination. 

2. ISTA 2 and 3 Series, as well as ASTM D 4169. These involve general simulation performance tests via simulation designed to mimic the conditions that may be experienced during the shipping process. 

These include: 

3. A third type of personalized test, depending on the characteristics of the product itself and the real distribution cycle to be endured by the product. 

In this case, it is common to use recording devices such as a Data Recorder, which provide real information regarding transportation conditions. 

In addition to the tests mentioned above, other types of simulations can be performed, including: 

  • Compression tests using simulation equipment to measure the resistance of a package to compression forces. 
  • Rotational impact and drop tests in simulation systems to measure the protective capabilities of the package in a laboratory setting. 

All of the aforementioned requirements must be taken into account when deciding on the medical packaging design. These processes are aimed at detecting potential risks linked to the distribution cycle with the purpose of redesigning or optimizing the package. This leads to a higher safety for the goods and a reduction in costs associated with damages during transportation. 

Do you want to know more about how to optimize your pharma packaging? At Safe Load Testing Technologies we have a track record of over two decades in transport simulation for the packaging industry. Get in touch with us and let’s talk about how to improve the safety of your medical device packaging.