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
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.
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Challenges for medical plastic components
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
Precision injection molding process
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
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