CleanRoom / Manufacturing Suite
Integrated design, construction management, commissioning and validation of new, 5,500sf Class 100 clean room/manufacturing suites for the production of implantable, regenerative skin grafts. Speed to market was important for our start-up medical device client with the goal of manufacturing an innovative product. The area included two lyophilizers, four Class 100 clean rooms, Class 100 cell production space and a wash suite with pass through autoclave and washer. Also included were all of the lyophilizer and suite support utilities such as a USP water system, air handling units, compressors, boilers, chillers and cooling towers. The entire building infrastructure was analyzed and upgraded to enable the commercial building to perform as a high performance cGMP facility.
- Single point, turnkey provider for the design, construction and validation of the facility
- Provided coordination between and during phases to enable interaction and transfer of ideas between the client and vendors - which not only saved time and cost, but also provided the highest possible quality
- Employed an integrated approach which reduced the overall schedule by at least four months
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