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Terminally sterilized medical devices must remain sterile and undamaged throughout transport and storage, making package design and testing critical. According to ISO 11607-2:2019, packaging must ensure devices can be sterilized and remain sterile until the sterile barrier is damaged or opened.

Controlled and qualified package designs and processes are essential to meet regulatory requirements and prevent risks such as patient harm, recalls, and loss of trust. Validating a sterile barrier system (SBS) involves design validation, process validation, and performance testing.

Critical elements must be identified before an accelerated aging plan development, and testing can begin. This paper identifies three crucial factors you need to know, the applicable test protocols and where the tools and calculators can be located.

We review the fundamental objectives and provide comparisons of ASTM D4169’s three Assurance Levels for Compression, Drop, and Vibration tests. Quantitative targets for each test and level are summarized. Links to WESTPAK’s Compression Test Video (demonstrating the three levels) and ASTM D4169 Vehicle Stacking Test calculator are provided as reference.

Countless hours and significant investment is made in the design and development of a new product. When your new product is finally ready for release to production, how confident are you that it will safely reach your customer and/or installation site without damage?

This paper examines the nature of package drop testing, the types and locations of drop impacts on packages in the distribution environment, why the typical specifications constitute over-testing, and the significance on package performance and optimization.

An assessment of available data and information describing the common carrier shipping environment was conducted. The assessment included the major shipping hazards of shock, vibration, impact, temperature, and humidity associated with the handling, transportation, and warehousing operations of typical distribution cycles. Previous environmental studies and current data are reviewed and assessed for applicability to general type cargo design and/or evaluation. The data for each hazard are summarized in a format considered most useful to packaging engineers when such data are available.

“Shipping tests” or “trial shipments” are often used to determine if a product/package system will survive the distribution environment without damage to the product. The reality is that a single shipping test is statistically insignificant; utilizing this approach will often lead to incorrect conclusions unless further testing is conducted. This paper will explore the reasons for this while recommending a much more feasible approach to evaluating product/package systems.

The Damage Boundary method of product fragility analysis has been around since the late 1960s and has proven itself to be an outstanding tool for reliability analysis, protective package design, and product fragility analysis. Yet it is not widely used in any of the areas where it can create a positive input. There are many possible reasons identified for this in the text. Possible different approaches and recommendations for procedure modifications are given in order to improve the effectiveness of product shock and vibration fragility assessment.

This article presents a list of common errors companies often make when specifying and validating insulated cold chain shippers. Keeping these mistakes in mind during specification development and package validation testing will help save you and your company money and time. The article also offers tips on finding the right testing laboratory for your validation testing needs.