Pharmaceutical FDA Regulated Facility

McClure Engineering performed the design to upgrade a confidential pharmaceutical plant to meet the current stricter regulatory requirements. The facility is regulated by the Food and Drug Administration (FDA), European Medicines Agency (EMEA), and World Health Organization (WHO).

Initially, McClure Engineering performed a facility assessment to determine what areas were currently not meeting the standards and developed the necessary projects to gain compliance. McClure Engineering designed the following projects to meet current compliance:

50,000 sq. ft. Warehouse (cGMP and Non-cGMP areas): The warehouses store raw incoming products and finished products. The project was designed to include a new HVAC system to meet the specific temperature/filtration requirements of the products. The spaces were designed to be less than 75° F. The finished product areas were also designed to have high-efficiency Particulate Air (HEPA) filtration. The project included new custom air handlers served by the existing chiller plant.

10,000 sq. ft. Tableting Suite: Temperature and humidity were critical to the suite and the current systems were not meeting those conditions. The project was to add a supplemental desiccant air handler to help dehumidify the space to meet current requirements.

Facility Space Pressurizations: Through a study, it was determined that the facility needed better space pressurization control to reduce product contamination between adjacent spaces. The space HVAC was rebalanced to achieve new space pressures.

cGMP Gowning Rooms: New air handlers were added to each gowning room. The gowning rooms were designed with positive space pressurization, HEPA filtration, and a minimum of six (6) air changes per hour.

Chiller Plant Upgrades: Since additional chiller capacity was needed from new projects, McClure Engineering designed additional chiller modules (200 tons) to be added to the existing plant. The pump impellors were also replaced for added pumping capacity.

Pressurization/Balancing of Labs: The existing laboratories needed balancing and control to meet new pressure requirements. Equipment in the space balanced chemical fume hoods, autoclaves, bio-hoods, and the general supply and exhaust air.

cGMP Packaging Air Handler: A new air handler was designed to meet the current compliance requirements. The custom air handler was electric heat and was tied into the existing chilled water system. . The spaces were designed to minimize air change per hour requirements, HEPA filtration, and space pressurization cascades.

Small Batch Weigh Up: The project was to design a cGMP Weigh Up Suite that included temperature, humidity, and pressure cascade requirements. The room included an Airlock and a Material Storage Room.