Case Study – Buffer Delivery System
A young life-science company required a buffer solution storage and delivery system for their novel diagnostics platform.
The project was split into two phases – firstly to provide an on-board buffer package with the required shelf life, and secondly, to provide a reliable, repeatable buffer release puncture method.
Both phases were successfully delivered, allowing the company to progress to the next stage of their product development, satisfy investors, and enable further funding.
- Providing 12 months shelf life of a pre-determined volume of buffer, in a flexible blister pouch with easily punctured lid.
- Working within a fixed space within an existing device and analysis instrument – into which any additional puncture mechanism would need to be accommodated.
- Meeting a minimum and maximum puncture force requirement already defined by the analysis instrument.
- Ensuring products would reliably puncture at point of use, and prematurely during storage and handling.
- To provide a scalable solution, which indicative production costs for future large-scale manufacture.
PHASE 1 APPROACH
- A materials comparison exercise to identify a range of suitable substrates, to go forward to part development and testing based on security of supply, formability, seal-ability, and moisture barrier.
- Physical testing of materials, partnered with projected calculation of annual moisture loss, to enable a data-driven choice of the best material combination.
- Functional prototype manufacture, enabling stability testing to demonstrate that initial shelf life was in line with theoretical values.
- Longer term shelf-life testing carried out whilst the next phase of the project was undertaken.
PHASE 2 APPROACH
- Concept generation of various pierce and burst mechanisms, leveraging experience within FlexMedical team, and engaging industry expertise.
- Use of 3-D print and Vacuum Cast prototyping to allow quick turnaround of functional tests on concepts, which could be ruled in or out, or modified based on the data.
- Extensive testing regime to verify design to allow investment in Prototype Injection Mould tooling.
- In-house assembly of mouldings with puncture needle and sealing mechanism to provide initial batch of pre-production modules for testing.
- FlexMedical solutions were able to deliver both phases of the project successfully.
- The empirically measured shelf life conformed very closely to the theoretical calculations initially made, and thus within the value specified by the customer.
- Modules were shown to puncture within the specified window of applied force.
- Buffer fluid was delivered to the rest of the device successfully, when required.
- The customer was able to meet investor milestones.
- The customer could proceed to the next stage of product development.