The Importance of Pharmaceutical Packaging Testing

In recent years, advancements in science and technology, coupled with rapid economic and social development, have enabled the globalization and e-commerce integration of goods. As a result, packaging demands across various industries have grown steadily—driven by the increasing need for robust protection during transportation. Over the past decade, China's medical product manufacturing sector has maintained a strong growth trajectory, characterized by high product value-added, stringent regulatory requirements, and consistently robust market demand.

Meanwhile, the booming growth of the packaging industry has also boosted the medical packaging sector, spurring the development and continuous refinement of China's pharmaceutical packaging testing standards. At the same time, advancements in healthcare infrastructure and the complementary growth of inspection institutions are accelerating efforts to align with international practices. Moving forward, regulatory focus for medical packaging products will shift—from pre-market review to post-market surveillance, and from product quality testing to comprehensive checks of manufacturers' quality management systems—thereby further standardizing R&D, production, and business operations within the medical industry.

With increasingly stringent regulations, both pharmaceutical packaging and sterile medical device packaging must maintain their package integrity throughout the declared shelf life and under specified transportation and storage conditions during the registration process—and must also provide corresponding evidence of pharmaceutical packaging testing.

So, what are the common standards, test items, and underlying principles involved in pharmaceutical packaging testing?

Medical packaging items are characterized by their high product added value, compact overall dimensions, and lightweight design—leading to the common practice of combining air and road transportation during actual shipments.

Based on this feature, pharmaceutical packaging testing can typically refer to ASTM D 4169-2016 DC13. Conducting transportation verification. This standard clearly outlines the test items and the sequence of procedures, comprehensively covering the common testing protocols typically used in conventional transport packaging inspections, while also providing a thorough simulation to assess potential hazards that may occur during transportation. The basic workflow for the transportation tests is as follows:

1. Establish the reference standard

The standard reference is typically ASTM D4169-16. "Standard Practice for Performance Testing of Shipping Containers and Systems" 》DC13.

2. Test item parameters determined

During pharmaceutical packaging inspections, at least one package unit from each product type must be provided. For the box samples, the structural dimensions of the packaging box must match those of actual transportation. Regarding parameter determination, the client can base their decisions on the real-world shipping conditions of the medical products—such as the number of stacking layers, whether the packaging is sealed, or if full-truckload transportation is used. The table below provides recommended parameters for typical sterile medical device packages; for specifics, please consult with the laboratory based on your particular situation.

What specific considerations should be taken into account when determining the transportation test parameters during pharmaceutical packaging inspections?

First is the stacking height—during the packaging design phase, the maximum number of stackable layers has already been taken into account. This needs to be clearly defined before testing; otherwise, we’ll have to work backward based on the standard recommended stacking height.

Second, if the outer packaging during actual transportation bears an upward-arrow symbol and clearly indicates a single designated direction of transit, this must also be explicitly stated before testing begins. According to the standard, unless otherwise specified, both the pressure test and the vibration test will cover all possible scenarios that may occur. A comprehensive assessment is conducted in three orientations—standing upright, lying on its side, and standing vertically—but often, due to the lack of supportive design in one particular direction, the product fails to pass the tests. The actual simulated transportation test process (in part) is illustrated in the figure below.

Finally, when inspecting pharmaceutical packaging, what specific precautions should be taken during the submission process?

First, accept the guidelines.

The standard general acceptance criteria are primarily based on two aspects: packaging integrity and product condition, making them applicable to packaging tests for any product. However, given the unique characteristics of medical products, more targeted and specific requirements can be proposed based on their actual usage scenarios—for instance, tolerances for label wear and acceptable levels of damage.

Second, the number of samples.

Whether it’s packaging material testing, accelerated aging tests, or transportation simulations, a certain number of backup samples are required—these can be used for retesting in case of unexpected situations during the testing process. If the product quantity is too limited, please communicate thoroughly with the lab technicians before testing begins.

Third, sample shipping.

During the sample shipping process, it is inevitable that the sample packaging will sustain some degree of damage due to handling by courier or logistics services. Therefore, we recommend using "overpackaging"—adding an extra layer of protection around the sample being tested—before sending it for analysis. This ensures the sample remains relatively intact throughout transit, safeguarding it from potential impacts during logistics operations that could otherwise compromise the accuracy of your test results.