Major delays in getting products to market, higher costs generated by design, testing, and management, increased lead times due to low-volume production runs and the changeover processes between products… these are just some of the consequences of over-customization of single-use assemblies.
A customized solution is when a customer says "I need to incorporate an untried or untested part or series of parts into an assembly". The resulting quality, performance and supply chain work will add time and cost to any project.
Indeed, customization, on average, adds a minimum of 16 weeks to a project, compared with only 10 weeks for a configured device - find out why in our blog "Has Single-use Customization Gone too Far?"
Customization does make sense in some applications but there are alternatives that can be effective in most cases. With a configured device, the end-user still owns the process in terms of design and functionality but the vendor is responsible for the materials, how the system is built and the performance limits of that system.
The Standard or "Off-the-Shelf" Solution
A standard solution is one your vendor already has on the shelf and is available immediately. If the end user's process requirements can be met, this can be a very timely and cost-effective solution. In reality though, applications are limited because too many compromises on process design and functionality have to be made in order to fit with an off-the-shelf solution.
The Configurable Solution
If there is no standard solution, a configurable solution should be considered. This approach can offer the biomanufacturer the best of both worlds because, by working within a design space, a vendor can offer all the benefits of standardization - such as quality, speed and supply chain optimization - combined with the flexibility of assembly design to meet the individual needs of a process.
The Design Space Concept
The design space solution - using a toolbox of validated parts and assemblies to build any device needed - can be used to achieve the benefits of standardization.
The materials used meet the quality and performance profile established during the creation of the design space ensuring the correct supporting documentation is in place prior to being included in a design. The design space is dynamic and materials can be added based upon end-user demand and the availability of supporting documentation.
With the design space approach, the end user is able to quickly design and specify a system to meet their process needs and the implementation of single-use systems will be faster as the vendor has pre-qualified the parts and the process for manufacture.
Using the design space concept for a configured solution offers significant speed benefits. The design space concept can be as quick as 10 weeks in total, from concept, design and delivery which results in significant time savings compared to a customized solution.
Within Parker domnick hunter’s bioprocessing design space, a toolbox of validated parts has been tested for quality and performance, and specifications are known. The supply is backed up and extra parts are kept in stock. Having a design space saves lead time, improves quality, performance and reliability of the supply chain.
Biomanufacturers who wish to simplify the production process – and move away from customized solutions – should consider configured solutions based around a validated design space where choosing from a defined toolbox will gain benefits in time, performance and quality.
This post was contributed by Guy Matthews, Market Development Manager at Parker Bioscience Division, UK.
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. Find out more at www.parker.com/bioscience