Cell Therapy cGMP Suite

BKM provided MEP services for the design of 4,700 SF of new cGMP cleanroom suite for a confidential client.

The suite includes three ISO 7 suites, two ISO 8 suites, and support spaces, including warehouse area, QC labs and office area. The cleanroom suite was designed within an existing lab building located in downtown Baltimore, MD. A new once-through rooftop air handling will be provided to serve the clients production suite to maintain environmental monitoring, proper air change rates, space pressurization and comfort conditions. The centralized exhaust system will be designed to isolate specific suites for flexibility and decontamination processes by use of vaporized hydrogen peroxide. A new run-around glycol loop will provide new energy recovery between the exhaust air stream and the 100% outdoor air to pre-condition the supply air for reduced energy consumption. A new air-cooled chiller will support the cooling needs for the suite, along with new clean steam generators for humidification needs. Heating water will be extended from existing building utilities to provide pre-heating within the AHU and reheat within the suite. New medical grade compressed air, oxygen, carbon dioxide and nitrogen will be provided to the ISO suites for use at incubators and bio-isolators. Liquid nitrogen dewars and piping will be provided to support critical low temperature freezers for sample preservation. A stand-alone building automation system for the suite will be provided, independent from the building systems for regulatory purposes. The renovation provided the client with a flexible cGMP suite for work on their current CAR-T cell therapies and future therapy research.

Electrical work included modification to the existing tenant service by combining meters and feeders to serve the expanded suite. New electrical distribution panels will be provided to serve the HVAC and lab equipment. A new 350 kVA natural gas tenant generator will provide standby power for critical lab equipment, including incubators, refrigerators and freezers as well as HVAC fans to maintain space pressurization in the event of a loss of normal power. A new stand-alone central uninterruptable power supply system will be provided to serve the equipment.  New cleanroom lighting and controls were provided as well as general illumination in the adjacent spaces. Automatic controls were provided in all spaces in the surrounding support areas of the cleanroom suite.