Key factors are part function, service environment, reprocessing, media exposure, tolerances, handling and the required documentation. For instrument components in particular, it is important to assess early whether material, geometry, mould and injection moulding process are suitable for the intended application.
Plastic Parts for Medical Technology
Function first: what does the part have to do?
Whether an instrument handle, housing, guide element, insulator, coupling component or single-use part – the design starts with the specific function. Key factors include fits, snap-fit and sealing areas, sliding surfaces, grip characteristics, electrical insulation and the secure retention of additional components.
These define the function-critical characteristics: Which contours must remain free of flash? Which surfaces must mate cleanly? Which tolerances affect assembly, reprocessing or handling? BERGER translates these requirements into the tooling concept, process window and inspection strategy.
Assess material and reprocessing together
Many medical technology applications require materials that withstand mechanical loads, can be cleaned or sterilised and support the required documentation. High-performance polymers such as PEEK or PPSU can be appropriate where temperature, resistance to media, dimensional accuracy or repeated reprocessing demand it.
Material selection remains application-specific. Data-sheet values alone are not sufficient: wall thicknesses, flow paths, shrinkage, demoulding, surface requirements and subsequent loads all influence whether a material is suitable for stable production.
Tooling for critical geometries
Medical components often feature thin walls, undercuts, sealing contours, fine snap-fit geometries, slide features or inserts. The mould determines whether these features can be reproduced reliably – through parting lines, mould spotting, venting, gating, mould temperature control and a design suited to demoulding.
BERGER therefore considers the part, mould and process as one system. The aim is a geometry that delivers the required function while remaining suitable for injection moulding, inspectable and repeatable throughout production.
Washer-disinfector and cleanroom processes as required
At BERGER, injection moulding takes place outside the cleanroom. If the application requires additional cleanliness, defined cleaning or protected handling, the downstream steps are integrated accordingly. Where required, parts are loaded on the unclean side, cleaned in the washer-disinfector and unloaded on the clean side. Alternatively, parts can be transferred into the cleanroom under controlled conditions via the airlock without prior washer-disinfector cleaning. Visual inspection, handling, assembly and packaging can then be carried out in the ISO Class 7 cleanroom.
The required cleanliness level is defined by the customer. BERGER implements the agreed requirements in a traceable process chain – from injection moulding through any required washer-disinfector cleaning or controlled airlock transfer to inspection, handling, assembly and packaging.
Frequently asked questions in medical technology
High-performance polymers may be appropriate where reprocessing, chemical resistance, mechanical performance, insulation or dimensional stability place particular demands on the part. The key question is not the material class itself, but whether the material reliably supports the part’s function throughout the intended use and reprocessing cycle.
Critical contours, thin walls, sealing surfaces, snap-fit areas or insulating structures are assessed early in part and mould design. Gating, venting, slides, mould spotting, demoulding and the inspection concept must work together so that the required function is achieved consistently in both mould trials and production.
When agreed cleanliness, assembly or packaging requirements call for controlled conditions. The specific process is defined for each project – using washer-disinfector cleaning or controlled airlock transfer, followed by the required cleanroom steps.
