Equipment for biopharmaceutical manufacturing (bioprocessing) that is intended to be used only once (or for a single manufacturing campaign) and then discarded is referred to as a single-use system (SUS). Single-use systems are the future of therapeutic drug biopharmaceutical processing, offering significant advantages over traditional reusable stainless-steel systems and partially disposable systems.
SUS equipment typically consists mostly of plastic parts that have been gamma irradiated, sealed, and disinfected. These systems, are manufactured in a cleanroom, double bagged, and then sterilized using gamma, EtO, or x-ray sterilization methods, ensuring a sterile system for every batch while also being highly efficient and cost-effective.
The main advantages of SUS over traditional stainless steel (or less frequently used glass in bioprocessing) are that the equipment is pre-sterilized, eliminating the need for cleaning, sterilisation, and validation of sterilisation before use. Additionally, related complex steam, WFI, and other plumbing installed throughout bioprocessing facilities with large fixed stainless steel components are also avoided.
With SUS equipment, new processing lines can be set up and processes can be turned around considerably faster than with stainless steel equipment that needs to be cleaned, sterilised, and validated over the course of several weeks.
Additionally, the facility footprint can be significantly reduced, investment and construction costs can be significantly reduced, and new process lines and facilities can be operational much faster and more easily than with stainless steel due to the significantly reduced facility infrastructure requirements, including the lack of extensive plumbing or an on-site WFI plant, and the fact that bioprocessing suites can be as simple as empty rooms that can be filled with a SUS-assembled process line.
Single-use systems, which appear to be the antithesis of a global movement away from disposable products and processes, promote sustainability by eliminating the chemicals and resources, such as water and energy, required to sterilize reusable systems. Perhaps most importantly and critically, this is done at a low cost and with minimal process time, and it virtually eliminates the risk of cross-contamination because the product flow path is discarded and replaced after each batch.
SUT allows biopharmaceutical manufacturers to move away from sterilized equipment and consumables that are recycled or pose a risk when transferred into clean rooms. SUT has merged as a very successful technology, and many global pharmaceutical and biotech companies have gained significant experience in both upstream and downstream API manufacturing, as well as the fill-finish part for drug substances or drug products.
A growing number of pharmaceutical companies are incorporating this technology into their manufacturing processes. Pharmaceutical companies can develop reliable products using SUT-powered bioreactors without the need to sterilize containers. Companies that already use SUT report faster turnaround and manufacturing times, as well as simplified operations, due to less maintenance.
SUT-powered equipment is simple to set up. It takes 1 or 2 hours as opposed to stainless setups, which can take several days. Furthermore, there is no need for annual cleaning, sterilization validations, or minimal monitoring to keep the system running smoothly.
Single-use technology is an ideal solution for any biopharmaceutical company, regardless of the challenges of speed to market, flexibility, product quality, or operator safety. SUT has many advantages, with investment and variable costs being the most frequently mentioned; however, they represent only one aspect of a strategically important decision in production technology.
Today, single-use technology raises a slew of front-end issues, including process compatibility, leachable/extractable, film selection, backup supplier, and waste management. In addition, the quality assurance system must be expanded to include both raw materials and manufacturing technology.
In terms of investment costs, single-use technology outperforms stainless steel because single-use systems require less initial capex. Because single-use systems necessitate less instrumentation and utilities.
SUT also eliminates the need for sterilization and cleaning, as well as reduces the need for installation and support systems. This benefit allows a manufacturer to purchase more capacity on a limited budget, but it also has an effect on variable costs because a much lower investment sum must be amortized when compared to stainless steel.
As a result, the low initial investment cost can be attributed to lower variable costs, which ultimately favor the use of single-use systems.