OHSU

Shared Resources

OHSU Bio-Fabrication Clean Room Facility

CRM employee uses clean room facility

This unique clean room facility houses an ISO 6 and two ISO 7 classification clean rooms. It consists of 1800 ft2 of space and offers, in addition to the three clean rooms, a staging laboratory and gowning room. The clean room facility has a keyless infrared security system that allows and tracks access to the facilities. Only personnel with approved clean room training can access these facilities.

Staging Room

The facility is entered through the staging room. This is general laboratory space, which is equipped with a dishwasher, autoclave and a pass-through window to the clean rooms. It currently holds a refrigerator and an -80°C freezer. The space can serve as general laboratory workspace as well as an area to organize materials prior to their transfer into the clean rooms. The autoclave can be accessed from either the staging lab or the adjacent ISO 7 lab.

Gowning Area

From the staging room, scientists enter the gowning area that leads into the clean rooms. Prior to entering the gowning area scientists put on shoe covers, a facemask, hair bonnet and gloves. They then enter the gowning area where clean room coveralls, shoe covers, and head covers are mandatory to prevent shedding of particles.

CRM employees use clean room facility

The ISO 6 area (≤1000 particles/ft3)

This area has been used for general cell culture and tissue engineering applications research. Currently it is equipped with standard tissue culture equipment including two biological safety cabinets (6 ft. and 4 ft. laminar flow hoods) and two CO2 incubators.

Two ISO 7 areas (≤10,000 particles/ft3)

One of the two ISO 7 classification clean rooms has been used for tissue engineering projects employing recombinant elastin protein. This room is equipped with a chemical hood.

The second of the two ISO 7 classification clean rooms has been used for chitosan research. This room is equipped with a chemical hood as well as a VirTis Benchmark 2000·freeze dryer with a 12 cubic foot product chamber and data acquisition capabilities. This system is equipped with ‘stopperable’ shelves that allow lyophilization of proteins or other materials within sterilized vials for intravenous or intra-arterial studies.

OHSU Clean Room Highlights:

-HEPA air filtration
-DI and UF water
-2 sided autoclave
-Cell culture ready CO2 Incubators
-Chemical fume hood in each of the 2 ISO 7 labs
-VirTis Benchmark 2000 Lyophilizer with 12 cubic foot product chamber in one ISO 7 lab

Room particle counts are tracked for each room to maintain the facilities within specifications.  Walls and floors are swabbed and cultured on a regular basis to ensure and maintain a minimal bio-burden to the bio-fabrication facility.  The clean room facilities receive constant maintenance according to Federal Industry CMP and International Standard (ISO 14644-1) clean room parameters.