What is single-use manufacturing?

Single-use manufacturing, or more clearly manufacturing single-use devices, emerged about the mid-1980s and stemmed from single-use systems which were gaining wider use in the pharmaceuticals industry, in particular for the production of specialized drugs. Single-use manufacturing now involves the production of relatively complex disposable devices used in surgical procedures such as electrosurgery. Razor blades and their holders are another example. Such devices are usually complex items intended for a single use, as opposed to simple disposables.

If you’ve donated blood, you’ve seen that the PVC blood bags that hold your donation are more than just bags. They are examples of relatively simple single-use products. At first, the bags replaced glass bottles and soon became available with a plastic tube or two, connectors, valves, and vials for taking samples. More complex disposable products are used in systems for specialized or boutique drug production and may include disposable filters, electronics, and sensors.

The alternative to single-use systems, to follow the drug example, would be processes made of relatively inflexible stainless-steel vessels and reactors, hard piping, valves, and so on. Such a fixed system must be cleaned and sterilized, a relatively labor- and energy-intensive operation.

Single-use devices, by one calculation, are more cost-effective and faster to implement. Initial investments are said to be about 40% lower. Other advantages of single-use systems include:

• Lower production costs. They reduce capital expenditures and require less facility space. Single-use systems are adaptable to patient-proximity manufacturing, a consideration for epidemic and bioterrorism vaccine deployment.
• Energy reduction. Single-use systems reduce the need for the steam, hot water, ultra-pure water, and chemicals used to clean stainless steel components, and eliminate the need to revalidate conventional equipment. By one estimate, single-use systems use 46% less water and produce 35% less CO2. Researchers also calculate that the total energy consumption of single-use systems is roughly 50% that of stainless steel reactors.
• Improved safety. Single-use systems reduce the possibility of cross contamination while improving sterility assurance.
• Wider supply chain. More qualified vendors are ready to provide timely supply and service of components and systems.
• Speed. Less time is spent in changeovers for batch-to-batch and product-to-product.

In addition, some single-use systems are delivered gamma-sterilized and pre-qualified by the supplier. One online stat says 60% of contract manufacturing companies have begun implementing single-use technology.