This depends on the process, frequency, media exposure and part function. Depending on the requirements, engineering plastics or high-performance polymers such as PEEK or PPSU may be suitable. BERGER assesses material selection together with geometry, processing and the required documentation.
Plastic Parts for the Pharmaceutical Industry
Material selection for pharmaceutical applications
Pharmaceutical applications impose a range of requirements: chemical resistance, cleanability, thermal exposure, media exposure, mechanical function and suitability for defined packaging and handling processes. The material must suit the application and allow the required documentation to be provided.
BERGER therefore assesses material, part geometry and process together. For demanding requirement profiles, high-performance polymers such as PEEK or PPSU may be appropriate; for other tasks, engineering plastics are the more economical and robust solution. The specific function within the pharma-related process remains the deciding factor.
Cleanliness depends on controlled interfaces
Particles, residues and unintended contact often arise not within an individual process step, but at transfer points – after injection moulding, when parts are set down, during cleaning, airlock transfer, assembly, inspection or packaging. These interfaces therefore need clearly defined procedures.
At BERGER, injection moulding takes place outside the cleanroom. The required cleanliness level is defined by the customer. On this basis, BERGER determines whether parts are cleaned in the washer-disinfector and unloaded on the clean side, or transferred into the cleanroom under controlled conditions via the airlock without prior washer-disinfector cleaning. Visual inspection, handling, assembly, interim storage and packaging can then be carried out in the ISO Class 7 cleanroom.
Integrating containment and sealing functions into the part
In pharmaceutical material transfer, sealing contours, defined movement functions and safe handling are key. Hard/soft combinations, flexible sealing lips, rotary or snap-fit functions and protected product transfer must be coordinated in both the part design and the mould.
For these applications, the mould determines not only dimensional accuracy but also sealing edges, parting lines, flow pattern, flash risk and repeatability of the soft component. These points must be resolved before mould manufacture so that stable production does not depend on subsequent rework.
Validation, approval and production
Where a project requires qualified or validated process steps, BERGER carries out manufacturing qualification and process validation to the agreed scope – including IQ, OQ and PQ. This is based on agreed requirements, parts from mould trials, documented process windows, defined inspection characteristics and a robust production concept.
This turns a functional initial sample into a reproducible process, with traceable approvals, batch documentation and clear responsibilities for material, production, cleaning, packaging and handover.
Frequently asked questions in pharmaceutical applications
When customer-defined cleanliness, handling or packaging requirements call for it. Whether washer-disinfector cleaning or controlled airlock transfer is used is defined for each project.
Where required by the project, BERGER carries out manufacturing qualification and process validation to the agreed scope, including IQ, OQ and PQ.
Through project-specific documentation covering material, batches, approvals, inspections and changes. The scope and level of detail depend on the part, application and documentation requirements agreed with the customer.
