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 biopharmaceutical processing of therapeutic drugs and offer significant advantages over traditional reusable stainless steel systems and partially single-use systems.
SUS devices are typically made primarily of plastic parts that have been gamma irradiated, sealed and disinfected. These systems are manufactured in a clean room, double bagged and then sterilized using Gamma, EtO or X-ray sterilization methods, ensuring a sterile system for each batch while being highly efficient and cost effective.
The main advantages of SUS over traditional stainless steel (or less commonly used glass in bioprocessing) is that the equipment is pre-sterilized, eliminating the need for cleaning, sterilization and sterilization validation prior to use. Additionally, associated complex steam, WFI and other piping installed in bioprocessing plants with large solid stainless steel components are also avoided.
With SUS equipment, new processing lines can be set up and processes changed much more quickly than with stainless steel equipment, which has to be cleaned, sterilized and validated over several weeks.
In addition, the plant footprint can be significantly reduced, investment and construction costs can be significantly reduced, and new process lines and equipment can be commissioned much faster and easier than with stainless steel due to the significantly reduced plant infrastructure requirements, including the absence of it of extensive plumbing or an on-site WFI facility and the fact that bioprocessing suites can be as simple as empty spaces that can be filled with a SUS mounted process line.
Single-use systems, which appear to be the opposite of a global movement away from single-use 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 low cost and with minimal process time, and virtually eliminates the risk of cross-contamination as the product flow path is discarded and replaced after each batch.
SUT enables biopharmaceutical manufacturers to move away from sterilized equipment and consumables that are recycled or pose a risk when brought into cleanrooms. SUT has become a very successful technology and many global pharmaceutical and biotech companies have accumulated extensive experience in both upstream and downstream API manufacturing and fill-finish part for drug APIs or drug products.
More and more pharmaceutical companies are integrating this technology into their manufacturing processes. Pharmaceutical companies can use SUT-powered bioreactors to develop reliable products without having to sterilize containers. Companies already using SUT report shorter processing and production times as well as simplified processes due to less maintenance.
SUT-powered devices are easy to set up. It takes 1 or 2 hours as opposed to stainless builds which can take several days. Additionally, no annual cleaning, sterilization validation, or minimal monitoring is required to keep the system running smoothly.
Single-use technology is an ideal solution for any biopharmaceutical company, regardless of time-to-market, flexibility, product quality or operator safety challenges. SUT has many benefits, with investments and variable costs being the most common; however, they represent only one aspect of a strategically important decision in production engineering.
Today, single-use technology presents a number of front-end issues including process compatibility, leachability/extractability, film selection, substitute supplier, and waste management. In addition, the quality assurance system must be extended to both raw materials and manufacturing technology.
In terms of investment costs, single-use technology outperforms stainless steel because single-use systems require less initial investment. Because single-use systems require fewer instruments and aids.
SUT also eliminates the need for sterilization and cleaning, reducing the need for plumbing and support systems. This benefit allows a manufacturer to buy more capacity on a budget, but also impacts variable costs as there is a significantly lower return on investment compared to stainless steel.
The low initial investment costs are thus due to lower variable costs, which ultimately favor the use of single-use systems.