A recent Parker domnick hunter webinar discussed the question "Is Standardization Possible in a Custom Single-use World?". The webinar looked at how high levels of customization has led to some challenges in the implementation of single-use technology in bioprocessing and talked about opportunities for standardization that can lead to advantages in lead times, inventory control and supply chain robustness.
During the webinar, we conducted a poll to find out what our audience - made up of biopharmaceutical professionals from all over the world - thought about single-use standardization. And here are the results...
Challenges in implementing single-use technology
For over 20 years, single-use technology has offered a range of benefits in bioprocessing. However, there are still challenges associated with the implementation of single-use. In our first poll question, we asked the audience what challenges they still see in single-use implementation today.
59% of respondents revealed that they believed validation is still a challenge, while 45% felt that both the time to implement and cost were also significant challenges (n=33).
Could standardization be the solution?
At Parker domnick hunter we believe that all of these challenges 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.
So what is our solution? Standardization. As an industry, we should move away from custom solutions to configured solutions based around a validated design space.
There is broad scope for standardization but there is a lot of work to do on what should be standardized and who should be setting the standards. These were key considerations in other polls taken during the webinar.
81% of the audience thought that materials were an important factor that should be standardized, with testing & documentation ranked second at 73% (n=44).
There is a move towards standardization of testing driven by the Biophorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA) and this seems to be favourable with a significant proportion of respondents in our third poll.
33.3% of the audience believing that standardization should be lead by industry bodies and a further 36% opting for a combination of industry bodies, vendors, end-users and regulators (n=45).
But, is standardization even possible?
History suggests that it is. If we took a stainless steel project, the most likely material would be 316L which would be supported by a standard certificate and made with standard fittings. In this instance, time would be spent ensuring correct specification of the vessel and not discussing the materials of construction or how it is put together.
Our final poll question asked the audience if we could get to a position where ULDPE - a common film used in single-use bioprocess containers - could be regarded in the same way as 316L Stainless Steel.
The result was very encouraging with 56% of respondents saying yes (n=44).
Find out more
Parker domnick hunter has developed a dynamic but controlled design space and ISO Class 7 manufacturing clean room at our facility in Birtley, County Durham, UK that allows for the rapid design, testing and manufacturing of configured solutions.
To find out more about the opportunities for standardization in single-use and the advantages this can bring to the market you can watch the full webinar on demand.
This post was contributed by Guy Matthews, Market Development Manager at Parker domnick hunter, UK
Parker domnick hunter specialize 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 our dedicated bioprocessing microsite.