Protomold has enabled PyroXpress testing
Protomold has enabled PyroXpress testing, reducing background contamination risk.
As users, distributors and investors eagerly awaited PyroXpress, the time to market the ground-breaking test unit hinged on the speed and quality of parts provided by Protomold, the rapid injection moulding service from Proto Labs.
Bacterial endotoxin contamination is an issue all medical device manufacturers need to be aware of. Clinical implants - and all vaccines and drugs delivered by injection - have to meet strict guidelines to ensure that they are free of toxin. Releasing a contaminated product to market risks product recalls, fines, and even closure of manufacturing plants.
Most producers have to send away samples to specialist contract laboratories due to the cost of establishing a capable testing station - but this means batches of medical supplies can be held up in quarantine for days awaiting product release.
"It was clear that the industry needed test equipment that was far cheaper and could be used quickly, by anyone, on-site at the factory or plant," stated Emma Day, technical director at Inverness-based Highland Biosciences.
Initially, Highland Biosciences experimented with rapid prototyping based on stereolithography (SLA) technology, but the results were not ideal because it did not allow the use of actual design material, while SLA models can change their shape.
"We were facing up to either using the wrong material or paying for an expensive hard tool for injection moulding - until I saw the Protomold website. Because the cartridge is disposable it was vital to achieve the correct design as we could potentially end up making millions," Ms Day remarked.
Using Protomold, Highland Biosciences was also able to trial many materials with different design properties. From the performance data derived by this iterative process, the company settled on a final design material, which remains a closely-guarded secret. In total, the project has already generated four patents worldwide, with more in the pipeline.
Protomold allows turnaround of between three and five days for typical 100-part batches, with Protomold working hard to supply clean parts leading to minimal background contamination.
"Our customers will rely on this test to provide assurance before expensive devices and vaccines are released to market," she added.
PyroXpress comprises an eight-channel reader unit into which disposable plastic cartridges containing samples are slotted. The test starts automatically upon detection of the sample, with results appearing within five minutes. No special skills, tools or environmental conditions are required and the equipment offers a price tag that is an order-of-magnitude less than conventional chromogenic or turbidimetric kinetic systems.
PyroXpress is currently being scaled up to full manufacture and hard tools are in production. A starter pack will be available later this year offering: a PyroXpress eight-channel reader; 500 disposable cartridges ready to use; and a 12 month support package including two days of method development and validation.