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Leak detection and seal evaluation influence how pharmaceutical, biotechnology, and medical device packaging performs throughout storage, distribution, and use. As packaging formats evolve and regulatory expectations continue to mature, testing strategies have also advanced beyond traditional inspection methods. However, misunderstandings around leak detection persist, often shaping test selection and validation approaches in ways that do not fully reflect real-world packaging behaviour. Examining these misconceptions provides clarity on how seal quality inspection methods can be better aligned with product characteristics, packaging design, and quality objectives.

Understanding the Risks of Inadequate Leak Evaluation

When leak evaluation methods lack precision or consistency, package defects may remain undetected until later stages of the product lifecycle. Microscopic pathways in seals or materials can allow the ingress of gases, moisture, or microorganisms. Over time, such exposure may influence sterility, chemical stability, or physical appearance of the product.

Another challenge arises from test methods that rely on subjective interpretation. Visual inspection and manual techniques vary by operator and environmental conditions, which introduces variability into the evaluation process. This variability can obscure trends, making it difficult to identify recurring seal issues or process drift.

Limited detection capability also affects investigation efforts when packaging failures occur. Without quantitative data, assessing defect size or understanding how a leak formed becomes more complex. This lack of measurable insight can slow corrective actions and reduce confidence in packaging validation. In highly regulated environments, incomplete leak data may result in extended review cycles or additional testing requirements.

Inadequate leak evaluation may also influence supply chain outcomes. Packages exposed to temperature shifts, vibration, and handling stress may perform differently than anticipated if seal quality has not been thoroughly assessed. These challenges highlight the need for testing approaches that provide repeatable, data-driven results across a range of packaging conditions.

Key Myths in Package Leak Evaluation

Despite advances in testing technologies, several misconceptions continue to shape how leak detection and seal evaluation are approached.

Myth 1: Greater sensitivity always leads to better outcomes

Sensitivity is often highlighted when comparing leak detection methods, yet sensitivity alone does not describe how a package will behave in real use. Detecting extremely small leaks without understanding their relevance to product exposure can lead to over-interpretation of results. A more balanced approach considers measurable leak characteristics alongside product formulation, headspace conditions, and storage environment.

Myth 2: All leaks have the same impact

Leak pathways vary in size, geometry, and location, and these variations influence how gases or liquids move through a package. A defect in a sterile injectable container may lead to different outcomes than a similar-sized defect in a non-sterile or dry product package. Treating all leaks as equivalent overlooks the interaction between packaging materials and product attributes.

Myth 3: Visual inspection provides sufficient seal evaluation

Visual inspection remains widely used due to its simplicity, yet it cannot consistently identify micro-level seal defects. Channel leaks, pinholes, and material stress fractures often fall below the threshold of visual detection. While visual checks may identify surface-level irregularities, they offer limited insight into seal continuity or permeability.

Myth 4: Destructive testing offers higher confidence

Destructive methods such as peel or burst testing can provide information about seal strength, but they do not always reflect package performance under real storage or distribution conditions. These methods also limit sample availability and do not allow repeated measurements on the same unit. Non-destructive, deterministic technologies enable repeated evaluation and trend analysis without altering the package, which enhances data consistency.

Myth 5: A single test method suits all packaging formats

Packaging systems differ widely in material composition, seal geometry, and internal headspace. Rigid containers, flexible pouches, and combination format each present unique evaluation challenges. If one method applies universally can result in incomplete assessment of certain defect types. Test selection benefits from understanding the interaction between the method and the package design.

Misconceptions surrounding leak detection and seal evaluation continue to influence packaging test strategies across regulated industries. Overemphasis on sensitivity, continued reliance on visual inspection, and assumptions about uniform leak behaviour can narrow how package performance is assessed. These approaches may leave gaps in defect identification, data interpretation, and overall process understanding.

Shifting toward quantitative, repeatable leak evaluation methods provides clearer insight into how packaging performs across its lifecycle. Techniques such as vacuum decay offer pressure-based measurement of package integrity, while high voltage leak detection (HVLD) enables evaluation of liquid-filled, non-porous containers through electrical conductivity. Airborne ultrasound adds further visibility by identifying seal irregularities through sound-based detection, particularly in flexible and porous packaging formats. When applied thoughtfully, these technologies allow comparison of results across materials, seal designs, and production conditions.

By reevaluating long-held assumptions and aligning evaluation techniques with packaging characteristics, manufacturers can strengthen their approach to seal assessment and package integrity. Addressing these myths encourages more consistent testing practices and promotes clearer understanding of how leaks and seal variations influence overall packaging performance.