Medical Device CT Scanning for Plastic Parts: Geometries & Internal Inspections to Keep You Compliant

Medical device manufacturing is highly regulated. Precision is non-negotiable. Any dimensional variation or internal defect lurking in a plastic part can not only compromise the functionality of the product, but also endanger patient safety and result in expensive regulatory setbacks.

As a result, medical device CT scanning has become a leading inspection method for OEMs, engineers, and quality teams who need precise insight into complex geometries and internal structures.

Industrial CT scanning offers a full volumetric view of a part without cutting, altering, or damaging it, compared to the typical methods of inspection, which include touch probe, destructive testing, or 2D X-ray. This makes it especially valuable for small medical plastic components that contain complex internal features, which surface-based measurement techniques cannot accurately capture.

Why CT Scanning Is Ideal for Medical-Grade Plastic Components

Medical​‍​‌‍​‍‌​‍​‌‍​‍‌ device plastic parts, such as a syringe body, an inhaler component, a fluid delivery system, a surgical guide, or a micro-molded part , very often require precise dimensions and specific functional shapes. In addition, these components are quite often equipped with internal channels, micro-features, snap-fits, and assemblies that need to be checked to verify their performance and compliance.

Therefore, advanced medical device CT scanning for such components is recommended for its distinct advantages like :

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1. Full Internal & External Geometry Capture

A CT scan generates a very precise 3D digital model of the component, enabling engineers to see and measure internal and external features without cutting or destroying the component. This is required when confirming important details like:

• Flow channels
• Hidden ribs
• Sealed cavities
• Insert-molded components
• Weld lines
• Internal mechanical locks

Traditional metrology methods are not capable of reaching many of these ​‍​‌‍​‍‌​‍​‌‍​‍‌features.

2. Ideal for Small, Complex, or Flexible Plastics

Many medical plastic components are too small, too flexible, or too complex for conventional CMMs or optical inspection systems. In these situations, CT scanning becomes the most reliable option because:

• The components are extremely small
• The surfaces are reflective, transparent, or translucent
• The part bends or changes shape when a probe is used
• There are very tight tolerances that are located inside the part

For small plastic parts, the use of CT scanning is an effective way to make sure the measurements are accurate, repeatable, and conform to ISO ​​‌​‌​​‌​‌standards.

CT Scanning Reveals What Other Methods Miss

A significant number of medical device failures originate from internal defects—many of which cannot be detected through surface-level inspection. Comprehensive CT scanning helps identify these hidden issues, including:

• Voids, Air Pockets, and Gas Traps: These internal defects can weaken structural integrity, reduce sealing effectiveness, and disrupt drug delivery mechanisms.
• Short Shots or Incomplete Fills: If the fill of a molded cavity for a channel is incomplete, then it may cause performance issues in pumps or fluid delivery devices.
• Misalignments in Assemblies: CT scanning enables the engineers to examine both multi-component assemblies without dismantling them and is therefore suitable for assessing press-fits, ultrasonic welds, and other built-in joints.
• Wall Thickness Variations: Very thin walls in medical components are of utmost importance. CT scan inspections can quickly map the thickness of walls, even if they are uniform.
• Flash, Sink Marks, and Weld Lines: Some defects are quite evident on the surface, but a great number of them lie under the surface. CT scanning provides the full internal structure, making it easy to detect all defects.

Ensuring Compliance with FDA, ISO, and Regulatory Expectations

Regulatory agencies require medical device manufacturers to prove that their products are safe, reliable, and produced through validated inspection processes. CT scanning supports compliance by providing:

• Objective, traceable dimensional data
• Digital records for long-term documentation
• Consistent, repeatable measurement workflows
• Non-destructive failure analysis for CAPA reporting

Because CT scanning captures the complete internal structure of a component, it reduces risk and helps shorten verification and validation timelines.

Key Applications in Medical Device Manufacturing

Medical​‍​‌‍​‍‌​‍​‌‍​‍‌ device CT scanning is a flexible technology that can be applied effectively at various steps of the product lifecycle:

• Design & Prototyping: Use CAD-to-scan comparison for quick validation of the new design
• First Article Inspection (FAI): Obtain full dimensional data from just one scan
• In-Process Quality Checks: Detect changes in the consistency of the molding process
• Failure Analysis: Find defects internally without part destruction
• Reverse Engineering: Generate precise CAD models of the original components

Such data provide the means for manufacturers to optimize design, tooling, and production ​‍​‌‍​‍‌​‍​‌‍​‍‌processes.

Final Thoughts

As medical plastic components become smaller, more intricate, and increasingly critical to patient safety, advanced inspection methods are essential. CT scanning stands out as the only technology that provides a quick, accurate, and totally non-destructive visual of the entire internal and external geometry of the part; thus, it is invaluable in regulatory compliance and uniform product quality.

If your team needs reliable, high-resolution inspection for medical plastic components, NPC’s CT scanning services provide the accuracy and confidence required in today’s demanding medical device environment.

Trust NPC for inspection excellence. We ensure accuracy, compliance, and total confidence in every part you manufacture.