The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
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
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
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
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
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
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
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
Quality Gate 1
Fit for use metrology
Tailored plans for efficient inspection
Challenges
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
Inspection for tool correction and first article inspection
Highly efficient modeling
Challenges
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
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 Gate 4
Granulate analysis
Pre-processing quality checks
Challenges
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
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
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
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.
See how other customers have experienced ZEISS medical industry solutions
31.05.2023
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 %.
#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 85: medical plastics talk
ZEISS O-INSPECT: Applications in action - drug delivery
Third-party Content Blocked
The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
Third-party Content Blocked
The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
Third-party Content Blocked
The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
Third-party Content Blocked
The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
Third-party Content Blocked
The video player is blocked due to your cookie preferences. To change the settings and play the video, please click the button below and consent to use of "Functional" tracking technologies.
Download
ZEISS Medical Industry Solutions Brochure Plastics EN