Single-use technologies have emerged as a significant and growing resource in the biopharmaceutical industry but there is still some trepidation around their use, meaning that some manufacturers are missing out on the benefits they can bring.
It’s vital that manufacturers aren’t deterred from reaping the benefits of single-use technology — such as reduced cleaning requirements, decreased plant footprint, improved turnaround times, increased flexibility, and reduced risk of cross contamination — due to concerns or misconceptions around implementation.
Perceived roadblocks surrounding implementation, such as scale, automation, integrity, and product compatibility are delaying adoption, resulting in slower delivery at a higher cost of life saving vaccines and other biopharmaceutical products.
Our recent webinar Single-Use Technologies, What is Next? addressed some of these barriers. Participants were invited to share their concerns and were given practical advice on how to implement single-use technology. Here, we report on the issues raised and suggest how barriers are being broken down.
In a poll taken during the webinar, 27.6% of respondents said that integrity was viewed as the biggest challenge to implementation.
While it’s not possible to test single-use systems to the same degree as traditional stainless steel systems, visual inspection and pressure decay testing are actually rigorously implemented. Single-use systems also pose less risk in terms of leaks and faults, owing to the additional line connections present in stainless steel systems.
Manufacturing processes across the industry have evolved at such a pace that scale is not as big an issue as it used to be, but for 25.9% of the poll voters, it’s still a prominent concern.
However, factors such as the production of smaller batches, adoption of continuous processes, and a trend for companies to move away from larger, single-site manufacture have enabled single-use technology to become an even more attractive and scalable solution.
Product compatibility and compliance — cited by 15.5% of the poll voters as their main barrier to implementation—is under the spotlight more than ever. With a myriad of regulations to adhere to, choosing the right materials and taking a standardized approach is critical to the adoption of single-use systems.
Single-use technologies can streamline processes and help to achieve bioprocess consistency and control. In contrast, manual systems are labour-intensive with data acquisition, manual analysis, and physical manning of workstations as well as multiple operators, increasing the risk of human error and equipment variation.
Introducing an automated system reduces the number of operators needed, virtually eliminating the risk of human errors occurring. Further efficiencies can be achieved with faster product delivery; from conception to shipping, the process time can be reduced from sixteen weeks to just eight weeks.
While Parker domnick hunter recognizes that there are challenges to adopting single-use systems, we also believe that they can be addressed and managed in such a way that enables single-use assemblies to be manufactured in a robust and repeatable process in the quantities needed.
This post was contributed by Graeme Proctor, product manager - single-use technologies, Parker Bioscience Division, United Kingdom
Parker domnick hunter Process Filtration Division specializes in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. Find out more at www.parker.com/bioscience