Single-use technology is quickly gaining in popularity around the world because of the financial and operational benefits over traditional process methods using stainless steel. So, why should a biopharmaceutical manufacturer adopt single-use technology (SUT) in their bioprocess?
Stainless steel components and pipework must be repeatedly steam cleaned; however, single-use equipment can be pre-sterilized by the supplier using gamma irradiation, and is replaced after each batch reducing cleaning and cleaning validation requirements.
Stainless steel processes require a considerable amount of infrastructure to be present on site for processing and cleaning. SUT eliminates the need for a costly stainless steel process and associated utilities plant for cleaning and steaming.
Quicker batch turn-around times increase a facility’s throughput. With SUT, as soon as a batch is processed, a new pre-assembled and sterilized fluid flow path is installed and ready to process the next batch with no associated downtime for cleaning.
Plastic or silicone tubing can be modified more easily and quickly than stainless steel pipework. This is particularly beneficial for contract manufacturing organizations (CMOs) as it allows them to change their processes more readily and safely compared to traditional methods.
Since the product flow path is discarded and replaced after each batch, the risk of product cross-contamination between batches is virtually eliminated when using disposable consumables.
Limits in scaleability mean that SUT is more suited to small-scale production. Large-scale manufacturers – for which flexibility is of less importance compared to managing the supply chain – may find it more difficult or not cost effective to completely adopt SUT, although single-use technology can still be integrated into a process where appropriate.
Plastics used in single-use systems can leach compounds under certain conditions. Single-use equipment suppliers must therefore provide extractable and leachables data to show that undesirable substances will not enter the drug product stream from components.
Quality control is another issue which must be addressed. With traditional stainless steel equipment, the responsibility of quality control is managed on site, but with SUT this falls to the supplier. Therefore, appropriate systems must be put in place to insure that suppliers provide components that meet cleanliness standards.
The sustainability issue of disposing of plastics after a single-use has raised environmental concerns. However, when compared to super-heated steam cleaning, which requires energy, cleaning chemicals and large amounts of water, single-use technology is arguably no less sustainable than stainless steel technology.
What do you think? What benefit of single-use technology is most important in your bioprocess? What are the biggest challenges with single-use technology? Share your experiences and insight in the comments section below.
At Parker domnick hunter, we specialize in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a manufacturer can control the fluid flow more effectively, ensuring the quality of the final product. Find out more about Parker domnick hunter's single-use solutions.
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