Medical Plastic Data Service Magazine



Our 30th Year of Publication
Page  1 of 5


Cover Story

Why Medical Device Packaging Fail ?


Medical device packaging plays vital role in safety and quality of Medical Devices. The products have to remain sterile throughout storage, handling and transportation.

Companies that package and ship medical devices are responsible for the health and safety of patients.

Following are some of the common mistakes which result in the failure of Medical Devices:

1. Losing sterile integrity

Most common defect in medical packaging , can happen from fractured thermoforms along with pinholes, slits, cuts, and tears in pouch packages, defects come from .caused by dropping.

2. Cutting too many corners

Many people in medical device manufacturing unaware of the need to test their packaging as per regulatory requirements, Don’t validate properly, they unknowingly risk letting suspect devices reach patients.

3. Not prequalifying package and product for compatibility

A common mistake , skips the preliminary evaluation, increasing overall validation costs because some part of the package fails. That means retests.

4. Ignoring the worst-case scenario

Need to decide the most common shipping configuration before validating the package.

Before working on a validation, write a protocol. It provides a blueprint for how testing will be done, including its purpose, scope, responsibilities, parameters, production equipment and settings, and acceptance test criteria. Validation qualifies the materials and processes that make the complete package. If one process is not right, the entire system breaks down and the manufacturer risks harm to patients.

5. Having the wrong sample size

Most common mistake is choosing a sample size that is too small and that renders results with no statistical significance. Determining the right sample size for testing can be challenging. Many factors play a role in determining sample size including what type of test it is (e.g. quantitative/variables or qualitative/attributes); what is the sample population; how many samples are available for testing; what are the economics; and what are the risk factors (e.g. confidence intervals).

6. Using the wrong package type/material

Using the wrong package type or material for the product is a package-product compatibility issue, which could have been avoided if pre-qualification of the packaging had been done at an early stage.

7. Squeezing oversized pouches into cartons

Pinhole defects in pouches can be reduced by inserting the pouch into a carton without folding, wrinkling or creasing the ends.

8. Not recognizing Tyvek® separation as a false-positive

One phenomenon that was discovered some years ago, but only really came to light when medical device packages began to be integrity tested routinely using bubble and dye-leak methods, was ‘sheet separation’ of the porous web of Tyvek®. In integrity tests, this ‘sheet separation’ appears as false-positive when the material is bent, folded, or wrinkled.

9. Performing accelerated aging at high test temperature

In ill-conceived attempts to reduce costs and time, some manufacturers decide to accelerate the shelf life or expiration date studies to unrealistic and indefensible limits, usually by raising the test temperature to a level that causes packages to melt down, warp, or change in other uncharacteristic behaviors. In addition, temperatures over 65°C are indefensible based on the rationale typically used to justify accelerated aging protocols.Temperature selection for the accelerated aging study should avoid unrealistic failure conditions, such as deformation due to melting. This advice is sometimes ignored in the haste to bring products to market faster.

(Source :

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