Tissue Processing Clean Rooms

This project is a production laboratory fit-out of an existing shell space into three class 100 processing modules and support for human tissue processing.

The renovation of existing space is designed to meet FDA Guidelines using NIH design criteria. The project includes clean rooms ranging from class 100,000 (ISO Class 8) to class 100 (ISO Class 5) for the processing of hard and soft human tissue for use in surgical transplants. This was designed as Class C Laboratory Facility due to acetone storage and distribution system of shell space. The facility includes processing modules, sample accession, clean/soiled protocol glass wash and sterilization areas, pre-process and post-process corridor protocols, gown and scrub facilities.

Project Information

Client/Owner:
Tutogen Medical, Inc.

Size:
4,100 Square Feet