Site Lines: Taking the LEED in cGMPs
Is a sustainable cGMP manufacturing facility achievable?
By Terry Jacobs
This article spun out of the attempt to determine if the design of a LEED-certified cGMP manufacturing facility was achievable and what cost and effort it would require. LEED, which stands for Leadership in Energy and Environmental Design, is a program that was created by the United States Green Building Council to promote sustainable and energy efficient design. The USBGC describes itself as "a coalition of leaders from across the building industry working to promote buildings that are environmentally responsible, profitable, and healthy places to live and work."
Photo courtesy of Jacobs/Wyper
As we explored this issue, several other questions came to the fore: Is there a business case for Green Design in Pharmaceutical Manufacturing? What comprises the Green movement in Chemistry?
Why should we be concerned about sustainable design? Because these are some of the environmental impacts of buildings:
- They consume almost 40% of all energy.
- They add 40% to atmospheric emissions.
- They use 68% of all electricity.
- They use 12% freshwater, 88% potable water.
- They take up to 40% municipal solid waste stream.
- They use significant amounts of land.
- We spend 90% of our time in buildings.
In 1999, 16% of the world's population consumed 80% of its natural Resources . The U.S., with 4% of the world's population, consumed 25% of the world's natural resources. (World Bank). Buildings in the U.S. dominate energy consumption, either directly by way of the structure's operation, or indirectly by way of the building's impact on patterns of land development and transportation.
At the time we started our study, no cGMP pharmaceutical manufacturing facility had been designed. Jim Dolceamore, PE, Director, R&D Engineering at AstraZeneca Pharmaceuticals LP challenged myself and Bernie Friel, PE of Genesis Engineers, Inc. to design a prototype facility and evaluate what advantages and obstacles may present themselves in achieving a LEED-certified cGMP Facility.
The methodology chosen was to design a mock, 130,000-sq.-ft. solid dosage manufacturing facility on a greenfield site, and to score it utilizing the LEED scoring system.
What's the Score?
To understand LEED scoring, we need to define LEED more fully:
1. LEED is a whole-building approach that encourages and guides a collaborative, integrated design and construction process.
2. It optimizes environmental and economic factors.
3. LEED has four levels of certification:
- LEED Certified
- Silver Level
- Gold Level
- Platinum Level
4. LEED has four modules:
- EB – Existing Buildings
- NC – New Construction
- CI – Commercial Interiors
- CS – Core and Shell
LEED's rating system includes six categories, which are weighted as follows:
- Sustainable Sites: 20%
- Water Efficiency: 7%
- Energy & Atmosphere: 25%
- Materials & Resources: 19%
- Indoor Environmental Quality: 22%
- Innovation & Design Process: 7%
We created a mock building program for the proposed new mock facility for “Greentech Pharmaceutical” with the following components:
The facility was designed along an architectural spine to allow for ease of expansion. We selected a greenfield site near public transportation, because this is a point in the LEED Category. Part of the Sustainable Sites approach is to locate facilities near public transportation, as well as to redevelop existing sites.
We established the design criteria based on the functions and gross square footage of the areas for all HVAC, plumbing, and electrical systems.
Major systems, based on the loads of this facility, included the following:
- Cooling System – (2) 500 Ton Chillers/Cooling Towers
- Heating System – (2) 180 HP Steam Boilers and 3,300 MBTU/H Hot Water System
- 3,000 kVA Sub-Station
- 500 kW Emergency Generator
- (14) Air Handling Systems – 210,000 CFM
Once we had designed a mock facility concept, the next step was to begin to score the facility utilizing the six LEED categories to evaluate how we could achieve certification and at what cost. Note that the prerequisites, by definition, are not optional.
Maximum points: 14
Points achieved: 7
Prerequisite: Erosion Control Plan
Since it was a mock facility, we could locate it where we wanted. The following are the seven points we achieved in this section:
Public Transportation Access – within half-mile of existing facilities
This point encourages locating facilities in areas that may be accessed without cars
Bicycle Storage and Changing Rooms Provided
This point is achieved with minimal effort and cost
Parking capacity does not exceed minimum local zoning requirements
Some local zoning may require less parking, some may require more. Don't overbuild parking.
Parking for 5% for fuel efficient vehicles
This is an inexpensive solution by providing striped spaces.
Site Development/Restore Habitat
This point is to achieve maintaining habitats
Use of Energy Star-compliant roof, high reflective and high emissive roofing
White roofing reduces heat loads
This point addresses reduction of exterior light pollution into the night sky
Maximum points: 5
Points achieved: 3
We specified vegetation that would not require irrigation
We decided not to irrigate
Reduce Potable Water Use by 50% (excluding process water requirements)
This is difficult, but achievable with waterless urinals and and water reducing fixtures
Energy & Atmosphere
Maximum points: 17
Points achieved: 4
Prerequisites: Fundamental Building Commission, Minimum Energy Performance, and Fundamental Refrigerant Management for reduction of CFCs
We achieved four points in this category, and considered a fifth (purchasing green power):
Optimize Energy Performance
Enhanced Refrigerant Management
Purchase Green power (35%)
Measurement and Verification
Materials & Resources
Maximum points: 13
Points achieved: 4
Prerequisite: Storage and Collection of Recyclables
Construction Waste Management – divert 50% from disposal
Construction Waste Management – divert 75% from landfill
10% Regional materials
Indoor Environmental Quality
Maximum points: 17
Points achieved: 14
Prerequisite: Minimum IAQ Performance – Environmental Tobacco Smoke Control
Outdoor Air Delivery Monitoring
Construction IAQ Management Plan During Construction
Construction IAQ Management Plan before occupancy
Low Emitting Materials: adhesives and sealants
Low Emitting Materials: carpet systems
Low Emitting Materials: agri and wood products
Controllability of Lighting for 90% of Occupants (assume in offices)
Thermal Comfort for Design (ASHRAE 55)
Indoor Chemical and Pollutant Source
Survey of Thermal Comfort
Daylight and Views of 75% of Spaces
Daylight and Views of 90% of Occupied Spaces
Maximum points: 5
Points achieved: 2
LEED accredited professional on team
In terms of innovation we elected to change company policy on air changes and setbacks for air changes in a non-occupied mode. This change would involve QA/QC and would mark an industry change in the Pharmaceutical Industry for air recirculating in the manufacturing facilities.
Breaking It Down
The following is a summary of the points we achieved:
| Sustainable Sites
| Water Efficiency
| Energy & Atmosphere
| Material & Resources
| Indoor Environmental
| Innovation & Design
| TOTAL POINTS
(Silver certification is
achieved at 33 points)
Costs are also an issue. The following are the anticipated cost increases to the project:
| Project construction cost
| Additional design cost for LEED
| Additional capital costs for LEED
| Total cost for LEED
| % of Total Construction Cost
||Less than 1%|
Issues for USGBC
In going through this exercise, we discovered several issues that the USGBC may want to address in the future, which are not acknowledged at the present in their criteria. They include the following:
- Heat recovery/energy efficiency for manufacturing processes.
- Is Process Water exempt from water requirements?
- Photovoltaic $$$ vs. roof area conflict for high loads.
- Setbacks on clean rooms during unoccupied times.
- Lighting control for manufacturing space.
- Definition of occupants for manufacturing space.
- Wind wake analysis – why not a LEED point?
- Daylight for manufacturing – how to define?
- Building efficiency – net/gross building volume and orientation
- 10.5% energy reduction is difficult – delete process loads?
- Why increase ventilation when it increases energy?
The following were the impacts for Project Impact (costs) for the facility:
- Increased Design Fees
- Increased Owner Participation
- Increased General Conditions
- Increased Construction Costs
The following are the benefits of designing based on LEED:
- Greater Employee Productivity
- Natural Light
- Indoor Air Quality = increased productivity?
- Operational Savings
- Maintenance (better documentation)
- Best Practices
In summary, the design of a cGMP pharmaceutical manufacturing facility is definitely achievable, and at a low cost, with great possible benefits to the project, the owners and to the environment.