Case studies

Softwall cleanroom for PCR test filling line

Angstrom Technology was appointed to design and build an ISO 6 softwall cleanroom for contract filling specialists, Erkol Fill, for their new automated PCR test filling line at its manufacturing site in Solingen, Germany.

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Healthcare
Cleanroom Design & Build
Mainland Europe

Key facts

ISO Class 6

To protect the filling line

45m²

Delivered in Germany for PCR test vial filling

Installed on a mezzanine

Space saving design

Goods in and change areas

To support the flow of people and product

The project

Contract filling specialists, Erkol Fill, has introduced a new automated PCR test filling line. To protect the integrity of the diagnostics components and support its ISO 13485:2016 certification plans, the company appointed Angstrom Technology to design and build an ISO 14644-1:2015 class 6 cleanroom at its manufacturing site in Solingen, Germany.

The cleanroom

This softwall cleanroom features a main area of 45m², with goods in and change areas. In the main area, 18 HEPA fan filter units are ceiling mounted to create a space that operates to particle counts according to ISO class 6.  Erkol Fill had an existing Angstrom Technology cleanroom that was being superceded by the new installation. To extend the original investment, some components were re-used in the new design.

The cleanroom installation followed the decommissioning of the original cleanroom, the installation of a new mezzanine, then the filling line installation. The project plan and high levels of communication helped the project to run smoothly through each of these stages.

Functional construction

The design is space-saving and functional as it creates a designated filling space in the large hall. The softwall construction meant that the cleanroom could easily be installed over the filling line machinery, which remains accessible for any maintenance that may be required.

Erkol Fill’s customers appreciate the hygienically clean bottling line. The new filling line can produce 3,600 units per hour and 50,000 units daily.

Custom built GMP cleanroom

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