The design space - a toolbox of validated parts and assemblies - allows an end-user to build any single-use device needed, utilizing a combination of validated parts.
Tubing, filters, connectors and other parts necessary to create an assembly are provided by the toolbox.The materials used meet the quality profile and have the right supporting documentation and performance characteristics and an established supply chain. prior to being included in the design. This requires controls regarding how something is designed, built and tested but enables speed and predictability of performance.
So how might a design space work?
Here’s an example from the bioprocessing industry.
A customer with a 1000-litre vessel wants its contents split into 10 different parts. A solution would be to take the 1000-litre vessel and attach 10 100-litre bags.
For a different process, there might be a 1000-litre batch and the customer requires it to be split into four parts; the solution would then be to use four 250-liter bags.
Or the next week, the customer has an 800-litre batch, and wants to split that into 100-litre parts.
In the past, customers may have a manifold of eight bags or a manifold of four bags and have to store different combinations, waiting for them to be used.
A more practical solution…
Instead of the approaches outlined above, a more effective solution could be to create a crosspiece that enables the customer to attach the bags of the right size and quantity to a spine that can be added to as needed.
In this way, if there is a 600-liter batch that the customer wishes to split into 100-liter bags, the solution is to attach six bags to the spine, rather than having a manifold of six to eight, or whatever the quantity may be. The creation of a manifolding device is a good example of simplification resulting in reduced complexity and fewer assemblies held in stock.
Working with filters
Here’s another example: when putting filters inline, the filter size is based on the batch size and the properties of the material to be filtered. Instead of integrating the filter directly into every customized assembly, the correctly sized filter can be attached via a manifold accommodating a multitude of batch sizes and materials.
Being able to choose the appropriate filter and the appropriate bag size means that the need to stock many different combinations of filters, bags and tubes is eliminated.
Configured solutions built around a controlled design space can be rapidly designed, tested and manufactured to a consistently high standard. This can have a significant affect on lead times compared to the industry standard.
This post was contributed by Guy Matthews, Market Development Manager at Parker Bioscience Division, United Kingdom.
Parker Bioscience Division 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. To find out more visit www.parker.com/bioscience