Implementing single-use powder-handling technologies in the pharmaceutical workplace can drastically improve a production line’s efficiency as it reduces or eliminates the need for extensive cleaning and steam sterilisation between batches. Alongside this, worker safety is enhanced and product purity is improved. But what about the environmental impact of using a disposable plastic liner versus a cleanable stainless steel system?
A 2014 study published in BioPharm International, conducted by GE Healthcare in collaboration with GE’s Ecoassessment Center of Excellence, compared the use of single-use technologies to traditional durable stainless steel process technologies in pharmaceutical manufacturing.
The study was extended to technologies at 100l, 500l and 2,000l working volume scales in the production of monoclonal antibodies (mAbs), antibodies which specifically target a certain antigen such as cancer cells.
A life-cycle assessment found that single-use technologies had a lower environmental damage impact overall than traditional systems, reducing the damage done to human health, ecosystems and resources.
ILC Dover is a global leader in single-use powder handling solutions solutions across multiple sectors. Its products, such as the EZ BioPac and DoverPac are among the single-use powder handling and transfer devices it produces for the pharmaceutical and bio-pharmaceutical sectors. With equipment such as this, the need for large quantities of energy-consuming steam, process water and water for injection (WFI) for cleaning and sterilisation are drastically reduced.
Single-use technologies are much lower-energy solutions than traditional stainless steel equipment
According to a separate study in BioProcess International, 100l of water are required to generate the 130°C sterile steam required to clean a stainless steel system for half an hour. Piping and the majority of filters are sterilized together with the storage tanks, although some filters are steam-sterilized separately. According to the study, this half-hour process uses 2,000 megajoules (MJ) of energy.
Disposable single-use components such as those supplied by ILC Dover are pre-sterilised with gamma radiation. According to the BioProcess International study this process only uses up 32MJ of energy.
This makes the disposable system comparatively more environmentally friendly, due to the low energy consumption of the gamma radiation compared to steam sterilising reusable system.
The same study states that cleaning of a stainless steel system, as distinct from sterilising, uses up even more energy, at 4,929MJ. This is largely influenced by the high energy demand for the production of pyrogen-free distilled WFI.
By comparison, disposable systems do not require cleaning, reducing the energy consumption here to zero.
There are obviously negative environmental impacts to single-use systems too. What they make up for in sterilisation and cleaning, they lack in terms of material disposal. While stainless steel systems have a lifetime of roughly 600 batches, single-use systems are just that – single use.
In all, the energy consumption for materials in stainless steel systems reaches 1,090MJ while disposable systems reach a much greater value of 4,124MJ due to higher materials use.
However, these combined figures still leave the energy consumption for a stainless steel system at 8,018MJ while disposables clock in at 4,156MJ. This means that the disposable set-up is ultimately better for the environment despite the resulting waste, due to the sheer levels of energy required in the cleaning and sterilisation of traditional systems.
Pharmaceutical powder handling is complicated and dangerous but employing expert single-use solutions from organisations such as ILC Dover means processes can be streamlined and manufacturers can bring their product to market faster, reducing their risks of contamination in an eco-friendly way.
