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to challenge the packaging through a simulated distribution environment.
The approach depends on the device, the packaging, the supply chain to de-
liver the product, and the risk management approach of the manufacturer. A
rationale should be developed as a justification. As discussed earlier, although
it is typical to conduct performance and stability testing separately, a vali-
dation engineer might decide to conduct performance testing serially after
accelerated aging if, for example, the product is shipped to the hospital up to
the end of the shelf life from a consigned stock. This would be particularly
important if the packaging has decreasing performance at the end of aging.
Fig. 5.8 lists a number of typical tests that are normally performed like
seal strength, burst strength, visual inspection, seal integrity (dye penetra-
tion), microbial barrier of porous materials, and mechanical properties of
the packaging materials. The validation flow in Fig. 5.9 uses the bubble
test [46] to assess the integrity of the entire pack. Bubble testing is popular,
since it is one of the only tests to assess the entire packaging although its
sensitivity of 250 μm is limited.

5.4 Power and sample size considerations for medical and
pharmaceutical device packaging
5.4.1 A conceptual overview of power and sample size

Statistical hypothesis testing forms the cornerstone for answering technical
questions in the development, quality assurance, and meeting regulatory
requirements of medical device and pharmaceutical packaging. Such testing
provides the evidence for ensuring patient safety during change manage-
ment and achieving validation requirements as described in Section 5.3.1.
Statistical techniques can be used to analyze data generated to characterize
SBSs and package systems as related to their performance. The following
list contains examples of the technical questions that may be answered with
hypothesis testing:
• Does the packaging maintain its properties after aging?
• Which film provides the highest package integrity?
• Is a suggested component equivalent to an obsolete one?
• Is the packaging process capable?
This section will address power and sample size requirements as related
to hypothesis testing and process capability.
The statistical concepts of power and sample size are crucial to ensur-
ing valid hypothesis tests and sound application of the scientific method.
Power and sample size will be addressed from a practitioner’s view point