ZEISS Medical Industry Solutions​

Quality Assurance for Medical Plastics​

Quality assurance for all types of medical plastics​

Medical plastics deliver a pharmaceutical compound to its target site. Therefore, they’re vital to human health in everyday life and must guarantee functionality and achieve their desired therapeutic effect. In ensuring proper production and complying with a variety of industry norms, you have to perform quality control on large volumes, process small features and non-standard geometries, and correctly handle plastics that may be transparent, sensitive, or prone to bending.​

Also known as medical combination products, medical plastics either comprise multiple components, combine multiple products, or may only be used together with a specific separate drug or device. ZEISS therefore helps you run fast checks on multiple components simultaneously, undertake multisensory inspections of flexible and soft parts, and perform freeform analysis to achieve optimum function and design of assemblies.​

Increasing requirements to quality assurance

Basic Plastic Pieces

Basic plastic pieces​

For basic plastic components such as the housing of an inhaler the challenge is particularly to ensure the quality of large production runs and GD&T.​

Multiple Plastic Pieces as Assembly

Multiple plastic pieces as assembly

The challenge with multiple plastic pieces as assembly is to capture small features of freeform parts. In most cases, the parts must be within tight tolerances to ensure the mechanical function while being produced in large batches. For example, syringes, insulin pens or various flow control (single use) parts are assembled from different plastic components.​

Complex Plastic Pieces with Electronic Components

Complex plastic pieces with electronic components

Self-infusion pumps, blood tests, and asthma inhalers with display are examples for complex plastic pieces with electronic components. These products often have sensitive surfaces and consist of thin bending or transparent plastics. Furthermore, there is also the challenge of a fast check with multiple components and materials.​

Click on the circle markers on the image to open the information box with more details.

Challenges for medical plastic components

Plastic part with scale
Burn, burr / edge

Quality Challenge:
Inspection of inner volume and verification of printed scale.

Possible process failures:
- Burn, burr / edge
- Defects & inclusions
- Fitting of volume to scale

Overmolded metal insert

Quality Challenge:
Design & function to be checked. Complex GD&T and assembly analysis. Inspection of finishing.

Possible process failure:
- Scratch

High-precision plastic part

Quality Challenge:
Quality solutions for injection molding needed.

Possible process failures:
- Flash
- Sink marks / warpage / shrinkage
- Black spots

Elastic rubber part
 Elastic rubber part

Quality Challenge:
Contactless measurement needed for flexible and soft parts. Defect inspection of incoming goods and GD&T required.

Possible process failure:
- Accuracy of fit

Plastic part with mechanical function

Quality Challenge:
Function of e.g. thread to be checked. Complex GD&T and assembly analysis.

Plastic design element

Quality Challenge:
Special focus on freeform analysis for function and design, plus GD&T and assembly analysis.

Tool manufacturing process

Tool Manufacturing Process

From design to tool correction​

Tool manufacturing should involve as few iteration loops as possible while ensuring accuracy and minimizing waste. Beginning with PMI-based inspection plans and extending through to the comparison of CAD models, this workflow has to ensure flawless handling of external influences such as electrodes.​

By promoting much faster and more cost-effective correction of high-precision tools, ZEISS solutions enable you to optimize your operations accordingly.​

Quality gates and solutions in the tool shop

From design to tool correction​
  • Fit for Use Metrology
    Quality Gate 1

    Fit for use metrology​

    Tailored plans for efficient inspection​


    • Creation and implementation of inspection plans must be made less costly and time-consuming​
    • Avoid potential errors and lost time caused by transferring dimensions from the drawing to the inspection software via manual copying​

    Your benefits with ZEISS​

    • PMI-based inspection plans – transfer PMI characteristics from CAD software to inspection software​
    • Import and export of a wide range of data formats​
  • Determination of Electrode Offset and Geometry
    Quality Gate 2

    Determination of electrode offset and geometry​

    Efficient and exact electrode and workpiece presetting


    • Eroding, manual alignment of electrodes, and performing measurements directly on the EDM machine​

    Your benefits with ZEISS​

    • Electrode inspection on CMM and 3D scanning systems​
    • Profit from shorter machine setup times, higher accuracy and much higher productivity​
  • Inspection for Tool Correction and First Article Inspection
    Quality Gate 3

    Inspection for tool correction and first article inspection​

    Highly efficient modeling


    • Tool correction process was previously known for being time-consuming, unreliable, and heavily dependent on expertise of individual user. Correction then required multiple iterations​
    • Ensure alignment of mold halves to reduce flashing​

    Your benefits with ZEISS​

    • CAD model comparison with ZEISS REVERSE ENGINEERING​
    • Tool correction process with fewer iterations saves time, boosts efficiency, and lends a competitive edge​

Precision injection molding process​

From raw material to finished parts​

From raw material to finished parts​

The structure of the manufacturing process enables highly efficient production of plastic components in large batches. Part design and requirements may vary considerably, however, with rotation capacity, elasticity, and compatibility with materials such as metal just some of the potential factors.​

It is of course essential to assess the raw material properties at the start of the process, both to detect impurities and to safeguard the desired product performance. And through the use of ultra-modern machines and systems based on optical technologies and computed tomography, it is now possible for very small parts featuring complex geometries to be manufactured with great precision – and evaluated via non-destructive checks.​

Quality gates and solutions in part manufacturing

Quality gates and solutions in part manufacturing
  • Granulate Analysis
    Quality Gate 4

    Granulate analysis​

    Pre-processing quality checks​


    • Perform quick and easy imaging and analysis of stock before production begins for more reliable products​

    Your benefits with ZEISS​

    • Impurity detection and classification – correlative workflow for light microscopes and scanning electron microscopes​
    • Images can be captured in ZEISS ZEN core, which features a GxP module to establish an auditable trail for each product or batch​
  • Geometric Dimensioning and Quality Inspection
    Quality Gate 5

    Geometric dimensioning and quality inspection​

    Material-friendly measurement


    • A final check must be performed on produced parts to ensure accuracy of dimensions and tolerances so that individual components fit together seamlessly in the assembly

    Your benefits with ZEISS

    • As the surface of plastic components is particularly sensitive to tactile measurement, optical solutions and CT solutions are preferred for this purpose​
    • Create a fullfield 3D scan of your part for inspection or even scan multiple parts at the same time ​
    • X-ray technology for volume visualization and inspection of internal defects
  • Particle Contamination
    Quality Gate 6

    Particle contamination​

    Twin approaches to effective analysis


    • Detect particle contamination in line with the exacting standards of the medical industry
    • Minimize maintenance costs via swift measurement and analysis of critical particles

    Your benefits with ZEISS

    • ZEISS Technical Cleanliness Analysis is a solution for light microscopes that ensures important settings are always correct and supports automatic image analysis in ZEISS ZEN core
    • Correlative Automated Parts Analysis represents an extension of Technical Cleanliness Analysis by combining your data from both light and electron microscopes in a single workflow. This approach enables you to characterize process-critical particles and identify contaminating particles in next to no time
  • Inspection of Assembly
    Quality Gate 7

    Inspection of assembly​

    Making the invisible visible


    • Non-destructive checks have to be performed on aspects such as mating surface contact, adhesion of components, and internal surfaces

    Your benefits with ZEISS

    • Various computed tomography (CT) hardware options including ZEISS METROTOM and ZEISS VoluMax enable you to see inside parts, even down to the powder or medication packaged within a given device.
    • Their non-destructive approach is quick and holistic, making it possible to perform full-scale inspections and pinpoint any potential errors.

A partnership in which constant cooperation, dialog, and the pursuit of progress result in innovation.​

Oliver Burgel​

Global Executive VP Operations Procurement HR & Quality MDS (EVP) at Gerresheimer​

See how other customers have experienced ZEISS medical industry solutions

Gerresheimer AG - Handle Challenging Quality Requirements in Medical Plastics with Responsibility

50 % shorter measuring time for medical plastics

Gerresheimer AG handles challenging quality requirements in medical plastics with responsibility. The company requires large numbers of fast and precise measurements on a wide variety of medical parts. With ZEISS they reduced their measurement time by 50 %.

Precision that saves lives

Precision that saves lives

whr Hossinger Kunststofftechnik manufactures CPAP generators for premature babies.

Application in action

  • #measuringhero | Episode 132: Medical plastics insights at Röchling

  • ZEISS O-INSPECT Application in Action: medical plastics, fast tactile single point probing

  • #measuringhero | Episode 101: Medical Plastics Tips & Tricks​

    #measuringhero | Episode 101: medical plastics tips & tricks

  • #measuringhero | Episode 85: Medical plastics talk

    #measuringhero | Episode 85: medical plastics talk


    ZEISS O-INSPECT: Applications in action - drug delivery​


  • ZEISS Medical Industry Solutions Brochure Plastics EN

    Pages: 17
    File size: 3 MB

Contact us

Would you like to learn more about our solutions for industries? We are happy to provide more information or a demo.

Do you need more information?

Get in touch with us. Our experts will get back to you.

Form is loading...

/ 4
Next Step:
  • Interest Inquiry
  • Personal Details
  • Company Details

If you want to have more information on data processing at ZEISS please refer to our data privacy notice.