Sustainability in pharmaceutical manufacturing
Sustainability serves as the core business principle for Evonik's Nutrition & Care division. Our innovations contribute to addressing climate change, promoting circularity, protecting ecosystems, and enhancing health and well-being. Our approach to sustainability at Evonik Health Care means supporting our customers with developing effective medications and therapies, while reducing adverse environmental effects. For our Drug Substance business, we enable sustainable manufacturing processes through three foundational principles:
- Technical expertise
- Capabilities to produce HPAPIs and complex APIs in a safe environment
- Know-how to offer innovative solutions
Sustainability throughout the pharma lifecycle
There are numerous opportunities to improve the sustainability from start to finish of a product’s lifecycle. These can be summarized in the following steps:
- Process Mass Balance
- Green Chemistry Principles
- Product Handprint
- Reagent selection
- Catalyst screening
- Smart registration commitments
- Reduction of solvent volumes
- Reduced isolations, purifications, and dryings
- Maximizing batch sizes
- Minimize waste streams and product losses to waste streams
- Maximize overall yield and control of impurity formation
- Debottlenecking analysis
- Preferred use of green solvents and reduction of solvents
- Solvent recovery or recycling
- Recovery of catalysts and precious metals
- Monitoring and tracking of energy consumption
- Green energy sources
- Offsite brokering of waste streams
- Incineration vs landfill
- Replacement/second-generation and market exit
Tailored solutions for more sustainable processes
When a customer comes to us with a request or an idea about how to improve sustainability, we can develop this in our labs and scale this up within Evonik’s assets. Examples of accomplished sustainability improvement programs include: optimization of solvent utilization, catalyst selection and optimization, replacement of chiral resolution by asymmetric chemocatalysis and organocatalysis, as well as switching from a batch to a continuous process to improve the safety of highly energetic reactions such as Grignard reactions. Over the past 10 years, we have jointly developed and scaled up continuous Grignard reactions, Grignard additions and Kumada couplings with partners in the pharmaceutical industry.
Another example is our manufacturing process for lactide, which is used in our biodegradable RESOMER® pharma polymer excipients. This process initially used toluene but it was switched to the green solvents isopropanol and ethyl acetate and the raw material lactic acid produced from renewable feedstock.
A “first time right” approach
Our goal for new processes is to adopt a “first time right” approach to avoid manufacturing batches with a failing out-of-specification (OOS). This ensures that a scale-up in the plant does not generate unnecessary waste, costs and extend delivery times. This goal can be achieved by sufficient process understanding, applying the Green Chemistry principles, and using monitoring methods and process analytical tools (PAT).
Waste reduction and solvent recycling
Solvents contribute significantly to greenhouse gas emissions in pharmaceutical manufacturing. By reducing solvent and reagent use through selection, development and implementation of novel technologies, pharmaceuticals can therefore be manufactured more sustainably.
- Methyl isobutyl ketone (MIBK) is used as a solvent in the production of an active pharmaceutical ingredient at large scale. In the past, this solvent was disposed.
- Since October 2021, this solvent is now being recycled locally.
- Although it is not possible for Evonik to use the solvent again for pharmaceutical processing, the recycled solvent is being used in other industries.
- At our Nanning site in China we adopt the same approach – here the solvent is taken back by the supplier.
Chemistry in water: Improving sustainability by reducing the use of organic solvents
Replacing organic solvents with greener reaction media and novel technologies is another approach to improving the sustainability of pharmaceutical manufacturing processes. Chemistry in Water reduces the footprint of chemical synthesis using the power of water. Surfactant-forming microscopic spheres (micelles) in water function as nanoreactors. These enable organic reactions, which are generally run in organic solvents to be performed in water.
Reducing waste through green process design and green engineering principles
Applying emerging technologies and process analytical technologies (PAT) can significantly help reduce waste. We are also focusing on recovering precious metals by organic solvent nanofiltration. Find out more about how we are using membrane technology for palladium recovery on our Catalysis website or by downloading our case study.
Learn more about our sustainability efforts at Evonik
You can also read more about our efforts to make pharmaceutical manufacturing more sustainable in the following articles:
Pharmaceuticals go green: how Evonik Health Care is adopting sustainability practices, principles and technologies
Green chemistry and sustainability metrics in the pharmaceutical manufacturing sector
Pathways for the pharmaceutical industry to become more sustainable
Evonik would love to be your partner in driving sustainability in your manufacturing processes! Please contact us if you would like to learn more.