ZEISS Medical Industry Solutions

Quality Assurance for Medical Plastics

Quality Assurance for All Types of Medical Plastics

I componenti plastici medicali sono fondamentali al benessere quotidiano degli esseri umani e devono poter garantire la funzionalità e gli effetti terapeutici desiderati. Per garantire una produzione adeguata e rispettare le norme del settore, è necessario eseguire controllo qualità su grandi volumi, essere in grado di elaborare piccole caratteristiche e geometrie non standard e gestire correttamente i materiali plastici che possono essere trasparenti, sensibili o soggetti a flessione.

I componenti medicali di plastica comprendono più elementi, combinano più prodotti o possono essere utilizzati solo insieme a un farmaco o dispositivo specifico. ZEISS ti permette di eseguire controlli rapidi su più componenti contemporaneamente, eseguire ispezioni multisensoriali di parti flessibili e malleabili, ed eseguire analisi a forma libera per ottenere un funzionamento e una progettazione dell’assemblaggio ottimali. 

Increasing Requirements to Quality Assurance

Parti di plastica di base

Per component di plastica di base come l’alloggiamento di un inalatore la sfida è garantire la qualità di grandi produzioni e di GD&T

Molteplici componenti di plastica da assemblare

La sfida con i componenti di plastica da assemblate è rispettare le piccole caratteristiche delle parti libere. Nella maggior parte dei casi i componenti devono rientrare in un range di tolleranza molto stretto anche quando sono prodotti in grandi quantità. Per esempio siringhe, penne insuliniche o parti di controllo del flusso liquido (monouso) [stantuffi] sono assemblate da parti di plastica separate. 

Componenti di plastica complessi con componenti elettronici

Le pompe di autoinfusione, le analisi del sangue e gli inalatori per l’asma con display sono esempi di elementi di plastica complessi con componenti elettronici. Questi prodotti hanno spesso superfici sensibili e sono realizzati con plastiche sottili, flessibili o trasparenti. Anche per questo motivo è necessario un controllo veloce di molteplici componenti e materiali.

Challenges for Medical Plastic Components

Overmolded metal insert

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

Possible process failure:

Scratch

Plastic part with mechanical function

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

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

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 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

Plastic design element

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

Tool Manufacturing Process

La produzione degli strumenti dovrebbe comportare il minor numero possibile di cicli di iterazione, garantendo al contempo l'accuratezza e riducendo al minimo gli sprechi. A partire dai piani di ispezione basati su PMI ed estendendosi fino al confronto di modelli CAD, questo flusso di lavoro deve garantire una gestione impeccabile delle influenze esterne come gli elettrodi. Promuovendo una correzione molto più rapida ed economica degli strumenti ad alta precisione, le soluzioni ZEISS consentono di ottimizzare le operazioni di conseguenza.

From Design to Tool Correction

Quality Gates and Solutions in the Tool Shop

Stock cylindrical metal. Colored to show grain size and direction of metal domains with an image from a microscope to the top left of the cylinder.

Fit for Use Metrology

Tailored Plans for Efficient Inspection

The challenge

  • 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 benefit 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

3D Scanning Software Suite

CMM Software

Initial Forging of the hipstem from stock material. Voids in blue to show possible defects in forging process. Magnified voids above the stem.

Determination of Electrode Offset and Geometry

Efficient and exact electrode and workpiece presetting

The challenge

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

Your benefit with ZEISS

  • Electrode Inspection on CMM and 3D scanning systems
  • Profit from shorter machine setup times, higher accuracy and much higher productivity

Coordinate Measuring Machines

3D Scanning Technology

Software for Electrode Offset

Forged stem shown to show flashing form the forging process. Would be as received part from the supplier.

Inspection for Tool Correction and First Article Inspection

Highly Efficient Modeling

The challenge

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

Your benefit with ZEISS

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

Software for Reverse Engineering

X-Ray

Coordinate Measuring Machines

3D Scanning Technology

Precision Injection Molding Process

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.

From Raw Material to Finished Parts

Quality Gates and Solutions in Part Manufacturing

Initial geometric dimensions of stock material and shape.

Granulate Analysis

Pre-processing Quality Checks

The challenge

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

Your benefit 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

Light Microscopes

Electron Microscopes

Microscopy Software Suite

Processed plastic part with highlighted dimensions. Image above shows voids on the interior of the part.

Geometric Dimensioning and Quality Inspection

Material-friendly Measurement

The challenge

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

Your benefit 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

Multisensoric CMM

CMM Software

X-Ray

Processed plastic part with highlighted dimensions. Image above shows voids on the interior of the part.

Particle Contamination

Twin Approaches to Effective Analysis

The challenge

  • 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 benefit 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

Technical Cleanliness

Processed plastic part with highlighted dimensions. Image above shows voids on the interior of the part.

Inspection of Assembly

Making the Invisible Visible

The challenge

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

Your benefit 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.

X-Ray

Do you need more information about ZEISS Medical Quality Solutions?

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ZEISS Medical Industry Solutions Quality Assurance for the highest medical standards