Presentation for ISPE Annual Meeting Bernie Friel, PE - Genesis Terry Jacobs, AIA - Jacobs/Wyper, Architects Orlando, Florida November 5, 2006

Energy & Sustainable Design – Build Green Is a Sustainable cGMP Manufacturing Facility Achievable?

Building Sustainability

Challenge Can a cGMP Manufacturing Facility be designed to achieve LEED Certification? Methodology A. Design a mock cGMP Solid Dose Manufacturing Facility B. Score the facility utilizing LEED criteria C. Summarize findings

Building Sustainability Background Statistics In 1999, 16% of the world’s population consumed 80% of its natural resources. The United States, with 4% of the world’s population, consumed 25% of the world’s natural resources. (World Bank) Buildings in the US 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. Buildings consume 1/3 of total US energy needs and 2/3 of its total electricity output.

Mock Facility

Greenetech Pharma Facility: 131,000 SF Mock cGMP Manufacturing Facility

Shipping/Receiving Warehouse Manufacturing Administration Central Plant QC Laboratory Packaging Support

ISPE cGMP Sustainable Facility

Building Sustainability

Site: Located on an existing site near public transportation

Design Criteria

Major Infrastructure Systems

• Cooling System - (2) 500 Ton Chillers/Cooling Towers

• Heating System – (2) 180 HP Steam Boilers & 3,300 MBTU/H Hot Water System

• 3,000 kVA Sub-Station

• 500 kW Emergency Generator

• (14) Air Handling Systems – 210,000 CFM

Sustainable Sites20%

Water Efficiency7%

Energy / Atmosphere25%

Innovation in Design7%

Indoor Enviornmental Quality22%

Materials / Resources19%

• Sustainable Sites (8 credits / 14 points) • Water Efficiency (3 credits / 5 points) • Energy and Atmosphere (6 credits / 17 points) • Materials and Resources (7 credits / 13 points) • Indoor Environmental Quality (8 credits / 15 points) • Innovation in Design (2 credits / 5 points)

LEED Categories LEED Certification Levels: •Certified 26-32 •Silver 33-38 •Gold 39-51 •Platinum 52-69

Sustainable Sites: 7 points achieved (14 point maximum) Prerequisites - Erosion control plan

• Public Transportation Access- ½ mile of existing.

• 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 roof compliant, high reflective and high emissive roofing.

• Interior/Exterior Lighting.

LEED Points Achieved

LEED Points Achieved ISPE

Water Efficiency 3 points achieved (5 maximum) Prerequisite: None

• Water Efficient Landscaping

• No Irrigation

• Reduce Potable Water Use by 50%

(Exclude process water requirements)

LEED Points Achieved ISPE

Energy and Atmosphere 4 points achieved (17 points maximum) Prerequisite: Fundamental Building Commissioning

Minimum Energy Performance

Fundamental Refrigerant Management

• Enhanced Commissioning

• Optimize Energy Performance ( 10.5 % ?)

• Enhanced Refrigerant Management

• Purchase Green power (35 %)

• Measurement and Verification

Lighting Design

Electrical Energy Loads (KW) Lights7.6%

Equipment22.2%

AHU14.5%

RF0.7%

EF/RAF4.4%

Cooling System39.2%

HW Pump0.4%

CA & Cold Storage11.1%

Energy Usage Cost Lights3.9%

Equipment11.4%

Cold storage5.9%

Data Ctr.10.4%

AHU Admin2.1%

AHU Mfg33.3%

Cooling11.6%

HW Pumps0.5%

Heat & Humidif ication20.9%

LEED Points Achieved ISPE

Materials and Resources: 4 Points achieved (13 Maximum) Prerequisite: Storage and Collection of Recyclable

• Construction Waste Management- Divert 50% from disposal

• Construction Waste Management- Divert 75% from landfill

• 10% Regional materials

• Certified wood

LEED Points Achieved ISPE

Indoor Environmental Quality: Points 14 points Achieved (17 maximum) 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

Indoor Air Quality: Points 14 points Achieved (17 maximum) Prerequisite: Minimum IAQ Performance

Environmental tobacco smoke control

• Indoor Chemical and Pollutant Source

• Controllability of Lighting for 90% of occupants (assume in offices)

• Thermal Comfort for Design (ASHRAE 55)

• Survey of Thermal Comfort

• Daylight and view of 75% of spaces

• Daylight and Views 90% occupied spaces

LEED Points Achieved ISPE

Lighting Controls

Personal Controller

Daylight Harvesting

Occupancy Controller

Smart Time Scheduling

Wall Switch Controller

Task Tuning

Variable Load Shedding

Personal Computer Interface with Lighting Controller

Innovation - 2 points achieved (5 Possible) No Prerequisite

• LEED person on team

• Client has 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.

LEED Points Achieved

LEED Summary Possible Points

Area Achieved Maximum

Sustainable Sites 7 14 Water Efficiency 3 5 Energy & Atmosphere 4 17 Materials & Resources 4 13 Indoor Environmental Quality

14 15

Innovation & Design Process

2 5

TOTAL POINTS (Range would be certified to silver( 33 ))

34 69

Additional Costs ISPE

Cost Project Construction Cost $40,000,000

Additional Design Cost for LEED $100,000

Additional capital costs for LEED $265,000

Total cost for LEED $365,000 % of total construction cost Less than 1%

Project Impact (Costs)

• Increased Design Fees

• Increased Owner Participation

• Increased General Conditions

• Increased Construction Costs

Project Impact Benefits

• Greater Employee Productivity

• Natural Light

• Indoor Air Quality= increased productivity?

• Operational Savings

• Maintenance (better documentation)

• Best Practices

Issues for the USGBC U.S. Green Building Council • 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?