February 11, 2019
Single Use Technology vs. Stainless Steel: Why Dinosaurs die!
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?
Benefits of single-use technology
1. Reduced cleaning requirements
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.
2. Decreased plant footprint and capital investment
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.
3. Improved batch turn-around times
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.
4. Increased process flexibility
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.
5. Reduced risk of product cross-contamination
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.
Challenges of single-use technology
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 ensure that suppliers provide components that meet cleanliness standards.
Sustainability issues – SUT vs steam cleaning
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.
Safety – or better yet, solidity – single use requires upgrades!
Of course there is no such thing as the perfect Jack-of-all trades. However, in times of CAR-T, single use technology and its advantages should hardly be questioned any longer. And there is not shortage in terms of innovations.
Companies like Single Use Support GmbH from Austria have tackled the challenge to expand established single use elements by means of technological add-ons as well as shell systems for all batch sizes, while maintaining the flexibility and at the same time warranting maximum security and protection, impact resistance and the content’s quality.
Is single use technology only suitable for small batches?
The answer is a clear no – even if Cryovessel manufacturers like to claim the opposite, which comes as no surprise; after all, their raison d’être rests on increasingly unsound footing while the modular single-use shell systems developed by Single Use Support GmbH are gaining more and more traction, not least thanks to their expandability by Fill & Drain as well as Freeze & Thaw systems.
Bulk.Stream is a customized process for single-use bags of all batch sizes.
Checkout MITS.2D – mobile integrity testing system for single-use bags: