Single-use technology (SUT) has been adopted on a global scale since its introduction 20 years ago and its benefits are well-recognized.
Thousands of single-use products are now in use and entire processes are being run in single-use format. End users have been encouraged to customize a solution for every operation, scale and product. Industry experts estimate that 80 per cent of assemblies for new processes are customized.
The flexibility offered by customization has indeed been an attractive proposition compared to fixed stainless steel systems, which could only be modified through time-intensive, costly engineering and revalidation work.
However, perhaps customization has gone too far. While there will always be a need for customized assemblies, a customized solution should only be considered when the process absolutely demands it.
The need for customization should be driven by the process needs and quality requirements. What may seem to be a new requirement to the Process Development Engineer has likely been encountered previously by the supplier and this expertise should be exploited.
Customized assemblies are being employed when there is no need for them to be used: one biopharm organization, for instance, was reported as having more than 2000 different assemblies in use.
So what are the consequences of excessive customization?
Customization, on average, adds a minimum of 16 weeks to a project. Why is this important? Because as soon as a manufacturer patents a drug, the clock starts ticking: a delay in getting a product to market can result in millions of dollars in missed sales.
How exactly does customization lead to longer implementation times?
Here’s a scenario. An end user has a project and a need is identified. The solution is a customized single-use device with a part that has not been used in an assembly before. The end user approaches a single-use systems provider. At a minimum, before use quality and safety issues must be met, and a number of issues should be resolved before the new device is built into the assembly. This takes time, both for the vendor and the end user – and this delay may not have been accounted for in the project plan.
Excessive customization leads to complexity – here are some examples:
- There is the need to stock and control many low-volume items (including managing and writing-off expired stock).
- Lead times for products are increased due to low-volume production runs and the changeover processes between products.
- The potential for quality challenges increases in smaller productions runs of complex assemblies using customized parts.
- Costs are higher because of the time required for the design, testing, and management of single-use systems.
For vendors, customization requires time to:
- Ensure product safety, compliance and performance
- Verify supply chain reliability
- Confirm fit with manufacturing capabilities
- Manage parts and components supply timelines
For end users, customization requires time to:
- Manage the design review process
- Coordinate specialist knowledge or training
- Plan ahead for any lead time issues for smaller quantities of customized items
- Perform quality checks on a higher quantity of smaller incoming batches
If more than 85 per cent of your single-use assemblies are customized, you are likely over customizing at the expense of time, performance and quality. This is a key challenge that shouldn’t be ignored – and the decision to standardize or customize should always be made on the front end, where upfront time and costs can be avoided.
This post was contributed by Guy Matthews, Market Development Manager at Parker Bioscience Division, United Kingdom
Parker Bioscience 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. To find out more visit www.parker.com/bioscience