Packaging for Medical devices, related products and materials is highly regulated and must meet very specific requirements.  The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device.  According to the FDA, all medical device manufacturers must obtain 510(k) approvals for any and all packaging. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1:2006.  The intent behind the ISO 11607-1:2006 standard is – “To provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package used to protect the device components during handling, distribution, and storage”.

Testing process

Medical package testing  assess the effects and interactions of the package contents, levels of packaging, external forces, and end-use. Usually, this involves packaging materials, primary packages, packaging components, shipping containers, unit loads, and associated processes.  Testing methodologies for packaging include Package Integrity Testing, Distribution Simulation Testing and Stability Testing. Each one of these categories has its own series of tests, which are described by various standards and test procedures written by ASTM International and ISTA (International Safe Transit Association). All individual standards in turn meet the requirements prescribed by ISO 11607-1:2006.

i) Distribution Simulation

These tests focus on the effectiveness of medical packaging in withstanding the shipping/distribution hazards. Besides the normal wear and tear of shipping, integrity must be maintained through  accidents such as boxes falling from a forklift or storage in a warehouse under many other heavy items. Subjecting items to distribution simulation tests is a requirement of ISO 11607-1:2006 compliance. The primary tests performed for Distribution Simulation are ASTM D4169 and various ISTA test procedures.  Depending on the testing procedure, packages would be subjected to some or all of the following tests:

ii) Stability testing

Medical packages must be tested for stability to ensure that products are safe, sterile and effective at least for the length of their claimed shelf life. In order to determine this, real time aging tests may be performed. However, due to the changing nature of medical technology, many products are obsolete before a long-term expiration date is validated, rendering real-time testing to be impractical. To expedite the product to market timeline, accelerated aging tests are performed in conjunction with real time tests.

Accelerated Aging is carried out by subjecting the product to unusually high levels of stress (changes in temperature, humidity, pressure, strain, etc.) designed to mimic the effects of long term storage and normal use.  A product can be released to market based upon successful Accelerated Aging of the package/product that simulates the period claimed for product expiration. The primary standards followed for this testing procedure are: ASTM F1980 (accelerated aging), and ASTM D4332 (atmospheric conditioning). It is important to note that ISO 11607-1:2006 requires that both accelerated and real-time aging studies to be performed simultaneously. Click here to access our Accelerated Aging Calculator.

iii) Package Integrity

Testing the package integrity will make sure the package seal is impermeable, protected and secure from multiple possible contaminants. The primary package must maintain its integrity through shipping, handling and distribution as well as storage in order to ensure both the sterility and consistent quality of the product. Tests conducted to achieve this validation and the relevant standards followed include:

Achieving Validation

The testing process is both costly and time-consuming (lasting anywhere from 30 days to several months), so time and finances should be planned accordingly. After testing is complete, a final report will be submitted which documents all test results, any corrective actions which were taken, and any other pertinent information regarding testing and packaging. And finally, remember that although the ISO 11607-1:2006 Standard is the benchmark, each customer may have particular requests which exceed these standards, so it’s best to remain flexible and prepared for further testing if necessary.

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