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Tutorials : Apr 1, 2011 (Vol. 31, No. 7)

LEED for a Biomanufacturing Cleanroom

Certification Verifies that Building Meets Environmental Sustainability Guidelines
  • Vikas Gupta
  • ,
  • Paul Lukitsch

The adoption of single-use products in bioprocess manufacturing has been growing at a 15–20% compounded rate in recent years. As part of this increasing usage, there have been numerous analyses comparing the use of disposables with that of traditional stainless steel manufacturing equipment. Initially focusing on a basic cost-benefit analysis of the two options, the scope has expanded to include assessments comparing the carbon footprint of the two technologies.

Drug developers are scrutinizing their environmental footprints and are investigating alternates to lower their carbon, water, and land footprints. Many manufacturers still believe that reusable stainless steel facilities offer the lowest environmental footprint as these facilities can be used to produce many batches of product over many years of operation.

Facilities engineered for single-use typically require less space and therefore less energy consumption. While additional solid waste may be generated, benefits include reduction in water, chemicals, and energy needed to clean and sanitize stainless steel equipment.

Assessing the Footprint

As part of a corporate sustainability initiative, EMD Millipore closely monitors the life-cycle impact of its Mobius® single-use product line from the earliest stages of manufacturing through disposal of used products and has put in place initiatives to reduce the overall carbon footprint. In doing so, we are able to help our customers also further their own green initiatives.

As a first step in assessing the footprint of our Mobius products, we conducted a complete life-cycle analysis (LCA) for a typical single-use assembly. Surprisingly, the analysis revealed that disposal of the single-use products was not, in fact, the biggest contributor to global warming potential. The LCA revealed that two areas, manufacture of single-use products and the mode of transportation of assemblies to the end user, can have a significantly larger carbon footprint.

These results led us to focus on the manufacturing process and, in particular, cleanroom operations, as a way to reduce the overall environmental impact of our single-use product line. In this article, we describe how our organization made improvements based on sustainable design principles and subsequently reduced the environmental impact of this phase of the products’ life cycle.

Capacity Demands Drive Green Initiatives

As production of our Mobius single-use assemblies increased to meet demand, it became clear that cleanroom operations at our existing facility couldn’t handle the increased manufacturing volume. A team was chartered to explore the possibility of renovating an unused warehouse and manufacturing space on the EMD Millipore campus into a new 10,000 square foot cleanroom and support areas to meet production demand. The team proposed to construct the facility in accordance with LEED (Leadership in Energy and Environmental Design) principles developed by the U.S. Green Building Council (USGBC). This was first of many initiatives to make our single-use product line more environmentally sustainable.

The LEED certification program is an internationally recognized green building certification system. The program provides third-party verification that a building or community was designed and built using strategies that improve performance in areas including energy savings, water efficiency, CO2 emissions reduction, improved indoor environmental quality, stewardship of resources, and sensitivity to their impacts. Projects receive points for activities in these categories and need to amass a sufficient number to achieve LEED certification.

Once our LEED certification initiative was launched, we faced an interesting challenge. The LEED certification process, although well defined to guide and certify the construction of office spaces and municipal buildings, offers limited guidance or precedence to certify a manufacturing cleanroom.

Our cleanroom project did not quite fit any of the specific building categories USGBC has developed. The closest category is LEED-CI (Commercial Interiors), designated for spaces within a building that are being updated or changed.

While this was essentially what was planned for the Mobius cleanroom area, the criteria as written didn’t quite align with our initiative. For example, one LEED-CI criteria is providing individual light and air controls, impossible to accomplish in a cleanroom. Another is reducing water from bathroom fixtures, difficult to achieve since there are no bathroom fixtures in the project area.

To navigate the extensive LEED certification process, we brought in a team of external consultants that specializes in design, processing, and commissioning of LEED-certified new construction and commercial interior building projects. The team’s role was to identify and implement sustainable items into the project, verify items to make sure they met or exceeded the LEED requirements, and gather and prepare final documentation to submit to USGBC for certification.

Scoring Points

The LEED process involves applying for and receiving points for environmental improvements and innovations undertaken as part of the project. Points are awarded for numerous activities in five environmental categories (sustainable sites, water efficiency, energy and atmosphere, materials and resources, and indoor environmental) and a special CI category, innovation in design.

This cleanroom project was eventually awarded Gold status, receiving points for its use of recycled and preferred materials, lighting controls and occupancy sensors, and sustainable site benefits.

Recycled and Preferred Materials

More than 77% of all construction waste was recycled. This was not an easy task given that the space had previously been used for storing flammable chemicals and had densely constructed walls, brick, mortar, and special blow-out panels that had to be demolished.

Rather than dispose of the material in a landfill, EMD Millipore sent the bricks and cement to a company that manufactures cement. Steel was sent to a metal-recycling firm, and the gypsum board was also recycled. The construction contractor used a detailed tracking process to show the numbers of tons recycled.

We received another materials-related point by using low VOC-emitting materials in adhesives and sealants, paints and coatings, carpet systems, composite wood and laminate adhesives, and systems furniture and seating.

Lighting Controls/Occupancy Sensors

The project also received points for incorporation of a special system that uses lighting controls and occupancy sensors. Segmenting the large production area into zones and using high efficiency T5-HE resulted in a greater than 35% reduction in connected lighting power density.

Energy Usage

The manufacturing step in the Mobius LCA study highlighted energy use in running the HVAC system in the cleanroom as having a significant global warming potential. As a result, we implemented a unique particle counting and air-handling system that reduced the energy use by 69%.

Most cleanrooms operate with a “set it and forget it” air-handling system and use a tremendous amount of energy to run powerful air-handling fans to support air conditioning and heating system through the HEPA filters installed in the ceiling. In most cases, fans run constantly, whether manufacturing is taking place or not.

To improve upon this, we installed particle counters in cleanroom return air walls to constantly test the space. This allows the fans to slow down automatically when the air meets cleanliness standards. On the weekends, or other times when no products are being manufactured, fan speed is reduced, resulting in significantly energy savings.

We were able to recognize a savings of 141,000 kilowatt hours per year, reducing our annual operating cost by $16,000. Since the system cost about $12,000, this initiative delivered a return on investment in less than one year. We are now considering implementing similar systems in our other cleanrooms.

Sustainable Site

This category awards points for alternative transportation options to and from the facility. The cleanroom facility included onsite bicycle storage, hybrid car parking, and new signage to promote carpooling.

Additional Benefits

The vacant 30,000 square foot area that has now been transformed into the cleanroom, warehouse space, offices, and associated supporting infrastructure would have been expected to create an approximately 25% increase in energy use for the facility in which it is located. Data shows that through use of LEED initiatives, the increase in energy consumption is only 5%, significantly lower than the anticipated increase.

The LCA’s manufacturing step also highlighted natural gas use for heating the building as a major contributor to the overall global warming potential. As a result of the LEED-enhanced commission process and subsequent building envelope improvements, we have seen a 28% reduction in natural gas used to heat the facility and expect similar savings during months when air conditioning is required.

As an organization, EMD Millipore is committed to protecting the environment and helping secure a more sustainable future. This commitment drives improvements in manufacturing processes, development of new materials for construction and promotes sustained innovation. The improvements made during the development of this new cleanroom, along with other energy saving measures implemented, form the basis for a new company initiative to achieve LEED certification for all future building projects.