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Product design

Designing products for environmental sustainability

GlaxoSmithKline aspires to be a sustainable company but recognises that it will take many years of hard work to develop and fully integrate design for sustainability principles into the business and to effect the necessary change in culture to move from aspiration to reality.  The initial focus will be to align environment, health and safety aspects of sustainability with the delivery of new products.

An example of the environment, health and safety focus is the GlaxoSmithKline eco-design toolkit, which was developed to support new product development and product transfer or redesign of processes.  The eco-design toolkit can help us bring products to market faster as scientists and engineers begin to apply the eco-design principles and practices to design-out potential problems early in development.  It also will help us bring products to market more cost effectively, because eco-design principles and practices will enable us to use less material and energy to make our products.  It will also enable research and development to address potential environment, health and safety (EHS) issues during process development before a process is handed over to manufacturing where the cost of addressing process-related EHS issues may be considerably higher. 

The toolkit is currently composed of five modules.  Four of the modules were significantly revised during 2003 to enhance usability and to promote a standard look and feel, and they continue to be updated as appropriate.  A fifth module, a Chemicals Legislation Guide, was added during 2005.  Each module was designed to ensure that all EHS impacts of materials, processes and services are considered, from the manufacture of the raw materials through to the ultimate fate of products and wastes in the environment.  During 2005 we worked with key R&D groups to build in their ideas and make the use of the Eco-design toolkit more compelling.  In 2006 we undertook a modification of the Green Chemistry Guide to make it more user-friendly for the chemists who use the guide, and we have embarked on a review of about 30 additional solvents to align the guide with other solvent selection tools used in R&D.  We are also attempting to identify potential replacement solvents for dichloromethane and dipolar aprotic solvents (eg, N,N-dimethyl formamide, N,N-dimethyl acetamide, and 1-methylpyrrolidin-2-one) in addition to solvents that can be derived from renewable sources.

Green chemistry metrics have been adopted by and integrated into R&D Chemical Development evaluations of most pilot plant campaigns.  These metrics are used by chemists and engineers to focus attention on reducing material consumption and waste.  R&D Chemical Development has agreed to a 2010 target to ensure that the average mass productivity for all phase III processes is 2 per cent.  This means that for every kilogram of drug substance produced, about 49 kilograms of materials will be required.  This is a significant improvement in materials use as the average mass productivity for initial pilot plant campaigns is on the order of 0.5 per cent.  This means that about 199 kilograms of materials are used to make every kilogram of drug substance, or about 400 per cent more material is used.

The eco-design toolkit modules currently available include the following:

Green chemistry guide
The Green Chemistry/ Technology Guide offers guidance to GlaxoSmithKline scientists and engineers on how the application of Green Chemistry concepts can enable more efficient use of resources, reduce environment, health and safety impacts, and minimise costs.  It includes:

• a ranking and summary of the most used chemistries and 'best-in-class' examples from well-developed GlaxoSmithKline chemical synthetic processes
• a ranking and review of issues encountered during chemical process design and development
• a ranking and summary of common technology alternatives for chemical processing
• guidance on materials, process alternatives, synthetic route strategies and metrics for evaluating chemistries, technologies and processes

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Materials guides
Solvent Selection - contains information on a wide range of solvents used within GlaxoSmithKline operations and also identifies solvents that should be avoided.  It:

• addresses recent legislative initiatives that affect future solvent use in the European Union
• assesses the life cycle impacts associated with solvent manufacture
• compares and ranks 47 solvents according to environmental waste profile, environmental impact, safety profile and health impact
• compares International Conference on Harmonisation (ICH) guidelines on allowable concentrations of solvents in active pharmaceutical ingredients against EHS characteristics of solvents
• provides information on boiling point and azeotrope formation to assist in the selection of separable co-solvents
• provides detailed information on physical properties and environment, health and safety issues

Base Selection – builds on the success of the solvent selection guide.  Requested by R&D chemists, the base selection guide contains information on a wide range of chemical bases used within GlaxoSmithKline R&D and manufacturing operations.  It

• compares and ranks 42 bases routinely used by R&D chemists according to their environmental waste profile, environmental impact, safety profile and health impact
• provides detailed information on physical properties and environment, health and safety issues

As part of a continuing vision to develop additional guidance on materials, a prototype materials selection guide was developed during 2005 for acids, catalysts and reducing agents.  This preliminary approach will be reviewed more broadly by various potential customer groups in R&D and GMS, with a view towards implementing the guide, if appropriate, in 2006.

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Green Packaging Guide
The Green Packaging Guide provides a packaging assessment tool, guidance and a business process for evaluating and selecting packaging options for the Pharmaceuticals and Consumer Healthcare businesses.  It has been extensively revised and now provides a new interactive section of the Green Packaging Guide known as WRAP - Wizard for the Rapid Assessment of Packaging.  WRAP is a tool and process that allows packaging designers and managers to rapidly assess the environmental impacts of existing and new packaging designs.  WRAP represents a significant enhancement and includes:

• a facility for benchmarking new and existing packaging designs.  Benchmarking is undertaken against GlaxoSmithKline’s existing product portfolio split into the different product types.  The method used considers five metrics that cover the product life cycle:
• manufacture of packaging
• mass of packaging
• biodegradability
• PVC content
• resource depletion
• a best-in-class example in each packaging category
• green packaging guides for nutritional healthcare products and consumer healthcare products

Using a scoring mechanism, WRAP generates a simple colour-coded report that clearly shows if the packaging associated with a product is better or worse than the appropriate benchmark.  WRAP also allows more detailed analysis of the underlying issues around the packaging and enables users to easily look at the effect of alternative packaging through scenario analysis.  The benchmarks will be updated and expanded as more data on packaging for GlaxoSmithKline products are collected.

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FLASC (Fast Lifecycle Assessment for Synthetic Chemistry)
FLASC is a web-based application that allows bench chemists to perform streamlined evaluations of the life cycle environmental impacts of new or existing processes.  FLASC is a process and tool that enables assessment of eight different life cycle environmental impact categories associated with materials used in synthetic routes or manufacturing processes:

• mass of materials used
• energy required
• photochemical ozone creation potential (POCP)
• greenhouse gas equivalents
• acidification
• eutrophication
• total organic carbon generated before any waste treatments
• oil and natural gas depletion for raw materials manufacture

FLASC helps scientists and managers to rapidly identify the greenest option, from a materials use perspective, by comparing and benchmarking processes and routes that are used to make GlaxoSmithKline products.  It identifies the materials that have the biggest life cycle environmental impacts and provides guidance on how to reduce those impacts.  The tool also quantifies the life cycle energy consumption, the emissions released and potential environmental impacts of the manufactured materials used in GSK chemical synthetic processes.  The FLASC system also may be used to track synthetic route or manufacturing process improvements throughout GlaxoSmithKline development activities.

During 2005 we added life cycle inventory data for 22 materials new to the FLASC database that are of interest to the Pharmaceutical Industry.  These materials include key raw materials, catalysts and complex specialty chemicals.  In addition, we made minor modifications to 32 existing materials to improve the accuracy of the FLASC data.  These additions broaden the scope and improve the life cycle impact estimations FLASC delivers.

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Chemicals Legislation Guide (CLG)
The CLG is the newest product stewardship tool.  While most of our product stewardship tools focus on best practice and issue identification, the CLG was developed in anticipation of chemicals legislation (eg REACH) in various parts of the world where legislators are working to phase out high hazard substances from routine use.  By combining guidance and hazardous substance lists from around the world, we were able to provide R&D and manufacturing scientists and engineers with a user friendly guide that considers hazard, volume and phase of use to deliver targeted guidance about a variety of chemicals of concern.  Because the tool is a spreadsheet it is easy to update twice a year and requires no special training to use.  Consequently, uptake of the tool has been very rapid and implementation was almost immediate.

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