Pond designed a manufacturing suite for this Confidential Biomedical Manufacturer’s facility in Georgia. The product produced by this system is a powder made of absorbable polysaccharide granules and is used to stop bleeding and promote blood clotting during surgery. The medical-grade starch process involves 100% ethanol, presenting the challenge of a potentially flammable condition in an ISO 4 cleanroom. Pond provided all design services, including lab gases, RO water purification, critical electrical systems, clean wall systems, HEPA and ULPA fan filter units, and mechanical air systems to control room-to-room pressure cascades.

The manufacturing suite for FDA phase 3 use has distinct personnel, material, and waste flows with scrub, airlock, topical, granulation, and final package rooms. Utilities were designed to be accessible for maintenance outside the cGMP areas.

Pond developed a comprehensive room pressure cascade plan, a thorough utility redundancy and resiliency study, a critical systems study, design of the production suite, air pattern, and filtration plans to provide for adherence to the project's FDA and EU standards. Ethanol was evaluated for maximum allowable quantities, and operators are protected from vapor exposure by the use of a once-through air handling system.