Facilities

Functional Areas

The 2,900 sq. ft. Philip S. Orsino Cell Therapy Facility features:

• five independent, class 10,000 clean rooms, each equipped with a biological safety cabinet, incubators, refrigerators, cell processing equipment and computer work stations
• cryopreservation facility featuring multiple liquid nitrogen storage tanks
• abundant support space for quality control/quality assurance
• raw materials storage and quarantine spaces
• administrative offices

The facility is designed to facilitate personnel and material movement between the various functional areas, which are well separated as illustrated in the Floor Plan.

Special Features

Surveillance
The facility is fully monitored through a computerized system linked to the
hospital automation system. All vital aspects of the facility, such as particle counts and air pressure in each of the clean rooms, as well as freezer temperatures and incubator CO₂ supply, are tracked 24 hours a day, 7 days a week.

An alarm system is in place to alert staff of any deviations from the set points. System measurements can be referenced from computer workstations throughout the facility, and records of all measurements are kept on file.

Air Handling
The facility has its own dedicated air handling unit, which is on emergency power. The air handler is equipped with a series of air filters and final HEPA filters. In addition, the air supply register in each clean room suite has a terminal HEPA filter.

Positive and Negative Pressure Rooms
One of the five clean suites is maintained at a negative pressure with respect to the remaining clean space. This suite is dedicated to high containment applications, such as those involving pathogens. The remaining clean rooms are maintained at a relative positive pressure, to minimize the possibility of product contamination.

Security
Access to the facility is restricted to authorized personnel by a coded card system. A second level of access further limits entry to the clean areas. The entire facility is monitored by a computer controlled security system.