The use of micronisation is vital to improve the solubility of oral drugs – enhancing their bioavailability by reducing particle size and increasing their surface area.
While the traditional methods of milling these products, using power mills or jet mills, are effective, the rise in high potency APIs coming down the pipeline means safety and containment are becoming ever more vital to the milling process. According to GlobalData’s Drugs database, in 2021, 97% of marketed drugs were small molecules[i] with an increase in high potency small molecule APIs driven by the rise of oncology pipeline drugs.
But another consideration is becoming increasingly important. Today, energy consumption and wasteful processes are key factors throughout the entire pharmaceutical manufacturing life cycle, with operators across the industry looking to improve their sustainability credentials.
This will be a hot topic for the pharma industry moving forward; sustainability was highlighted by respondents to a recent GlobalData survey[ii] which identifies the environment as the most important ESG (Environmental, Social, and Governance) concern for pharma manufacturing. The survey also revealed that one of the main challenges to achieving environmentally sustainable manufacturing is a lack of investment in expertise and technology.
Can CMOs continue to maintain a safe supply of critical products while also addressing the need to cut carbon emissions, energy use and waste?
Implementing sustainable strategies
Trends in sustainability and quality assurance were key themes discussed at the recent Convention on Pharmaceutical Ingredients (CPHI) Europe 2023 and according to CPHI’s Annual Industry Report, sustainability is a critical issue.
Uppermost among the listed challenges were stringent regulations related to product safety and efficacy, as well as market pressures. However, experts noted that the application of sustainable practices and process efficiency are closely linked.
Research collated by GlobalData highlights several ways that companies can make milling more sustainable by implementing various strategies and practices. These include:
Reducing the environmental impact: Companies can focus on reducing the environmental footprint of their milling processes, such as implementing in-house life cycle assessment to identify areas where environmental impact can be minimised.
Energy conservation: Energy-intensive processes within milling operations can be optimised to reduce energy consumption. This can involve replacing outdated, energy-intensive equipment with more energy-efficient alternatives and actively conducting energy conservation projects.
Implementing circular economy principles: This involves designing products and processes that enable the efficient use of resources and reduce waste generation.
By prioritising sustainability, the pharma industry can help reduce energy consumption and waste, resulting in lower operational costs, as well as enhancing their reputation and competitiveness in the market.
Designing more sustainable products
One company that is making meaningful improvements to its environmental and social impact is Frewitt.
Headquartered in Fribourg, Switzerland, and with subsidiary offices worldwide, Frewitt is an expert in powder grinding and milling, and has emerged as a leading company in this domain by consistently staying ahead of its markets and designing tools to cater to evolving needs.
The Frewitt PMV-320 high-impact pin mill is a product that exemplifies increased sustainability in design, with increased operator safety, reliability, less need for extra procedures and resources, and improved efficiency.
Conceived and designed to revolutionise the milling process, the PMV-320 is a single system combining both containment and micronisation processes via a controlled vacuum.
This patented system removes traditional risks, such as explosion, because no air is present in the system and reduced friction also results in less heating of the API product, thus maintaining its structure and preserving its bio-performance.
Other benefits include:
- Delivering a PSD range down to D 90 < 6µm
- Throughput up to 1000kg per hour
- Compatible for 0/20 ATEX – removal of traditional zone risks due to the process under vacuum
- Process can be easily contained up to OEB 5
- Rotor tip speed up to 250 m/s (depends on application)
- Vacuum reduces noise levels to below 69 dBA.
- Extremely low process temperature elevation
- Modular arrangement allows for maximum flexibility
Further, the PMV-320 requires the lowest possible electricity consumption and does not require any additional cyclone filters or separators.
An additional benefit is that, unlike jet mills, the PMV-320 requires no liquid nitrogen supply, due to the reduction of heating within the system. Removing this component from the process not only reduces costs, but also significantly reduces energy and greenhouse gas emissions which would otherwise be needed to produce and transport the liquid nitrogen.
A greener future for 2024
Since 1986, Frewitt has made it a priority to not only adapt and comply with all quality and ecological building standards, but to invest in new and more sustainable technologies.
The company is continuing this theme into 2024 by installing the latest technology – heat pumps and solar panels – onto its buildings. By covering more than half of the 1258 sqm of available surface area, the firm is looking forward to savings and becoming more than 40% self-sufficient in energy.
The heat pump installation will also save 25,150 litres of fuel oil per year, a huge saving in carbon emissions.
Group Commercial Director, Roy Housh, says of the project: “The aim of such a large-scale project is simple, to make Frewitt and its employees feel good, both ecologically and technically.”
For further information on Frewitt, download the free paper below.
[i] GlobalData: Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition:
https://pharma2.globaldata.com/Analysis/details/Contract-Small-Molecule-API-Manufacturing-Industry-by-the-Numbers—2021-Edition
[ii] GlobalData: Pharmaceutical Manufacturing ESG Survey – Towards a Sustainable Supply Chain:
https://pharma.globaldata.com/News/invest-now-to-reduce-manufacturing-harms-to-environment-says-pharma-survey_171344
