February 15, 2019
5 reasons why Single Use Technology is the way to goReading time: 3 minutes
Go no further – Single Use Technology has and is the solution for you and your patients. The financial and operational benefits are manifold and will blast traditional processes into the past.
We are backing this statement with 5 indisputable reasons to demonstrate why biopharmaceutical companies should solely be using Single Use Technology.
The great benefits of Single Use Technology (SUT)
1. SUT reduces cleaning requirements
Stainless steel components and piping have to repeatedly be cleaned with steam; however, disposable devices (single use) may be sterilized by the supplier by means of gamma irradiation and are replaced after each batch, thereby reducing the requirements for validation of cleaning.
2. Reduced plant footprint and reduced capital investments
Stainless steel processes require a significant amount of infrastructure for processing and cleaning on site. With SUT, the need for a costly stainless steel process and the associated supply systems for cleaning and steaming is eliminated.
3. Improved processing times for batches
Faster batch turnaround times increase the throughput of a plant. Once a batch has been processed, SUT installs a new pre-assembled and sterilized material flow path ready to process the next batch for cleaning without any further downtime.
4. Increased process flexibility
Plastic or silicone hoses can be modified more easily and faster than stainless steel tubes. This is particularly beneficial for Contract Manufacturing Organizations (CMOs), as they can change their processes more easily and securely than with traditional processes.
5. Reduced risk of cross-contamination of the product
Since the product flow path is disposed of and replaced after each batch, the risk of cross-contamination of the product between batches – as opposed to when disposable consumables are used – is virtually eliminated.
Challenges of the Single Use Technology
Due to the limitations of scalability, SUT is better suited for small-scale production. Large manufacturers, where flexibility is less important than managing the supply chain, may find the full adoption of SUT more difficult or less cost-effective, even though single use technology can still be integrated into the process.
Plastics used in disposable systems can leach compounds under certain conditions. Single use providers, therefore, need to deliver extractable and leachable data to show that unwanted substances do not enter the drug product stream from components.
Quality control is another issue that needs to be addressed.
Traditional stainless steel equipment manages quality control locally, but with SUT it is the responsibility of the supplier. Therefore, appropriate systems have to be set up to ensure that suppliers provide components that meet purity requirements.
Sustainability Issues – SUT vs. steam cleaning
The sustainability problem of the disposal of plastics after a single use has led to environmental problems. Compared to superheated steam cleaning, which requires energy, cleaning chemicals and large volumes of water, disposable technology is probably no less sustainable than stainless steel technology.
Safety – or better yet solidity: Why single use requires upgrades!
Of course there is no perfect overall solution. However, in times of CAR-T, Single Use Technology, and its benefits should hardly be questioned. And there is no lack of innovation.
Companies like Single Use Support GmbH from Austria have taken on the challenge of expanding established single use elements through technological enhancements as well as tray systems for all batch sizes. At the same time, they remain flexible while ensuring maximum safety and protection. They offer impact resistance and quality of content.
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 is no surprise. Their raison d’être rests on increasingly uncertain ground while the modular one-way tray systems developed by Single Use Support GmbH are gaining more and more traction, not least thanks to their expandability through Fill & Drain and Freeze & Thaw systems.
Bulk.Stream is a tailor-made process for disposable bags of all batch sizes.
Check out MITS.2D – Mobile Integrity Testing System for Disposable Bags: