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.