ISO class 7 medical device suites for manufacture of stent-grafts

Cleanroom case study: WL Gore Technology

Bassaire successfully completed 2 turnkey cleanroom suites on the WL Gore site in Dundee. The suites were designed, constructed, commissioned and validated to provide ISO 7 classification, with ISO 8 change and air lock facilities.

The two facilities were constructed in two distinct phases, the first build to relocate an existing clean room facility, the second to house the new product venture on the Dundee site, which was the manufacture of stent-grafts such as the GORE EXCLUDER®.

An essential requirement of the cleanrooms was that the due to the unknown nature of the service requirements, the facility needed to be adaptable to change. The facility was therefore built to allow easy access into service voids without affecting the integrity of the cleanroom.

Phase I was an 84m² cleanroom suite - Phase II was an 112m² cleanroom suite.