Thermoforming

Thermoformed parts are widely used in packaging, medical devices, automotive components, consumer appliances, and industrial products. They offer lightweight, cost-effective, and customizable solutions for high- and mid-volume production. Key benefits include rapid manufacturing, design flexibility, and material efficiency. Challenges include regulatory compliance, precision requirements, and durability in demanding environments.

Thermoforming is often preferred over other production methods due to its lower tooling costs, faster lead times, and suitability for producing large, lightweight parts. It offers greater design flexibility and supports a wide range of materials, including sustainable and recycled plastics. The process delivers high-quality surface finishes and simplifies secondary operations like trimming and assembly.

Thermoforming also generates less production waste and can be easily automated for higher-volume manufacturing. These advantages make it ideal for industries such as packaging, automotive, appliances, and medical devices, especially when cost-efficiency, speed, and design adaptability are important.

Industry Trends

Over the last 20 years, thermoforming has shifted toward sustainable materials, automation, and precision. Its use has expanded from basic packaging to high-performance parts in automotive, aerospace, and medical sectors. Demand for customization and short-run production has grown, driven by market shifts and just-in-time manufacturing. The medical field has seen major adoption, requiring cleanroom and traceable processes. These trends reflect evolving technology, environmental concerns, and more diverse application needs.

"Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives."
William A. Foster
quotes
Objectives and challenges in QA for thermoformed parts

Quality assurance is critical for thermoformed parts to ensure dimensional accuracy, structural integrity, and compliance with industry standards. It helps detect defects early, reduces waste, and ensures consistent performance—especially in packaging, medical, and automotive applications where precision, safety, and customer satisfaction are essential to success and brand reputation.

Consider the following goals, and the wide variety of flaws that can occur in the finished product.

Dimensional Accuracy ensures that the part meets design specifications and fits with mating components in an assembly.
  • Material shrinkage and thermal expansion
  • Tool wear or inconsistency in forming temperature and vacuum pressure
  • Difficult to measure thin-walled parts without deforming them
Wall Thickness Consistency affects part strength, functionality, and material usage. Thin spots can cause failure under stress.
  • Uneven material distribution due to poor mold design or inconsistent forming conditions
  • Measuring accurately without destructive testing is difficult
  • Variability in sheet material thickness before forming
Surface Finish / Aesthetics impacts the visual appeal, brand perception, and in some cases, functional (e.g., smoothness for hygiene or aerodynamics).
  • Dust, dirt, or contaminants can cause blemishes
  • Inconsistent heating or vacuum pressure may cause texture defects
  • Mold surface condition needs to be maintained meticulously
Material Integrity ensures structural performance and longevity. Defects like thinning, burns, or bubbles can compromise strength.
  • Bubbles can be hard to detect visually
  • Burn marks may not appear until after cooling
  • Visual inspections can miss subsurface or hidden defects
Trimming Accuracy impacts final geometry. Misaligned or uneven trims can lead to functional issues or part rejection.
  • Trimming often involves secondary processes that introduce variability
  • Warping during cooling can affect trim line positioning
  • Automated trimming systems require tight calibration
Cooling Control prevents warping or internal stresses, affecting dimensional stability and aesthetics.
  • Parts can warp after leaving the mold if cooled unevenly
  • Thick sections cool slower, introducing stress
  • Difficult to inspect warping until part fully cools
Color and Material Consistency are important for aesthetic matching, UV resistance, and compliance in regulated industries (e.g., food packaging, medical).
  • Color shifts can occur with over- or under-heating
  • Batch-to-batch material variation
  • Difficult to spot subtle color mismatches under inconsistent lighting
Adherence to Regulatory Standards is critical in industries (medical, food, automotive) with strict QA and compliance requirements.
  • Keeping up with changing standards (e.g., ISO, FDA)
  • Documentation and traceability of raw materials and processes
  • Testing can be time-consuming and require specialized equipment
Process Repeatability ensures consistent quality over large production runs, which reduces scrap and increases efficiency.
  • Even small changes in ambient temperature, humidity, or equipment calibration can affect results
  • Maintaining consistent operator performance and machine settings
  • Requires robust process controls and documentation
Mold Fit and Venting for proper vacuum seal and venting are critical for accurate replication of the mold’s shape and fine details.
  • Poor venting causes incomplete formation, especially in detailed areas
  • Dirt or material buildup in vents affects airflow and part detail
  • Mold wear over time may compromise fit and vacuum performance
2D vs 3D Solutions

A 3D inspection system offers significant advantages over traditional 2D vision systems when detecting defects in thermoformed or other complex parts. Here are key ways 3D inspection can outperform 2D:

Conclusion

Ajile Depthscan 3D Imaging Systems incorporate multi-camera and multi-view stitching for full coverage of parts, enabling detailed inspection of any size or shape of part. Ajile workflow automation and plugins for industry standard GD&T inspection software save time, increase throughput, and catch defects early before they result in material waste.