Cleanroom and washer-disinfector commissioned
Sheath assemblies as the driver for the cleanroom investment
The specific trigger for the investment was sheath coupling parts for endoscopic systems. These sterile single-use assemblies connect the endoscope and the sterile drape, form a sterile barrier between patient and camera system and therefore require high dimensional accuracy, dimensional stability and a reproducible latching function – together with defined cleaning and protective packaging. Until now these steps were covered by an external service provider. With our own cleanroom and washer-disinfector we now bring cleaning, inspection and packaging together in-house. This applies from the GEN1 assembly through to the GEN3 assembly and to comparable medical technology projects.
Cleaning, inspection and packaging as one continuous process
We do not regard cleaning, controlled handling, inspection and packaging as separate additional steps, but as a connected process chain – from the cleaned component to the protected, packaged part. The advantage lies in short, controlled routes: fewer interfaces, a lower risk of recontamination and end-to-end documentation from a single source.
This is relevant wherever technical plastic parts have to be cleaned to defined requirements, protected in packaging or prepared for downstream applications. Medical technology and pharma-related projects in particular benefit from clear workflows and reproducible boundary conditions.
The cleanroom as a controlled room-within-a-room system
The ISO Class 7 cleanroom was built as a room-within-a-room system covering around 25 m². Personnel, material and parts have separate, defined access routes that reduce unnecessary influences on sensitive products:
- Personnel airlock – controlled entry of personnel into the cleanroom,
- Material airlock – defined transfer of material in and out,
- Pass-through washer-disinfector – loading on the unclean side, defined cleaning and unloading on the clean side.
The technical basis is provided by airflow control, filtration through HEPA filters, defined pressure conditions and cleanroom-compatible equipment. ISO Class 7 under ISO 14644-1 defines the permissible particle concentration. What matters in day-to-day operation, however, is that the individual process steps remain controllable not only at rest but also during ongoing work.
Integrated washer-disinfector, microscopy and sealing process
The same washer-disinfector, designed as a pass-through unit, provides defined, reproducible cleaning of suitable parts, components and required process equipment. The cleaning process is validated through IQ, OQ and PQ and is therefore demonstrably under control. At the same time, the unit connects the unclean side with the cleanroom. Cleaned parts can therefore be processed further, inspected and packaged immediately under controlled conditions.
Visual inspection is carried out with a ZEISS microscope, while a Hawo sealing unit provides reproducible packaging. The result is a continuous process chain that can be fully documented – from the cleaned plastic part to protective packaging with a defined seal – matched to the specific customer requirements.
A look at the cleanroom and inspection process
Overall, this step extends our expertise in precision injection moulding by a controlled cleaning, inspection and packaging environment for demanding plastic parts. Do you have a part with requirements for cleanliness and packaging? Contact us.