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?

Sustainability

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%

The Building

We created a mock building program for the proposed new mock facility for “Greentech Pharmaceutical” with the following components:

Shipping/Receiving

Warehouse

Manufacturing

Administration

Central Plant

QC Laboratory

Packaging

Support

Architectural Layout

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.

Sustainable Sites

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


Bicycle Storage and Changing Rooms Provided


Parking capacity does not exceed minimum local zoning requirements


Parking for 5% for fuel efficient vehicles


Site Development/Restore Habitat


Use of Energy Star-compliant roof, high reflective and high emissive roofing


Interior/Exterior Lighting

Water Efficiency

Maximum points: 5

Points achieved: 3

Prerequisite: none

Water-Efficient Landscaping


No Irrigation


Reduce Potable Water Use by 50% (excluding process water requirements)

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):

Enhanced Commissioning

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

Certified wood

Indoor Environmental Quality

Maximum points: 17

Points achieved: 14

Prerequisite: Minimum IAQ Performance – Environmental Tobacco Smoke Control

Outdoor Air Delivery Monitoring

Increased Ventilation

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

Innovation

Maximum points: 5

Points achieved: 2

No prerequisites

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:

Area	Achieved	Maximum
Sustainable Sites	7	14
Water Efficiency	3	5
Energy & Atmosphere	4	17
Material & Resources	4	13
Indoor Environmental   Quality	14	15
Innovation & Design   Process	2	5
TOTAL POINTS   (Silver certification is    achieved at 33 points)	34	69

Costs are also an issue. The following are the anticipated cost increases to the project:

	COST
Project construction cost	$40,000,000
Additional design cost for LEED	$100,000
Additional capital costs for LEED	$275,000
Total cost for LEED	$375,000
% 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.

Terry Jacobs, AIA is a principal of Jacobs/Wyper Architects, LLP, a Philadelphia-based architectural, planning and interior design firm. He has more than 26 years’ experience in the design of design of pharmaceutical and biotechnology cGMP manufacturing facilities, R&D facilities, pilot plants and office and support functions. He can be reached at haj3@jacobswyper.com.