The state-of-the-art Sapphire technology is automatically fed and motorised in different axes so that the autoinjectors can be rotated to perform quality checks on their needles and ensure other parts of the device mechanisms are within position tolerances.
The X-ray equipment can also detect foreign bodies in the drug container, such as metal or glass particles as small as 0.1mm in diameter, within formulations that would otherwise not be visible to an inspector. And all at the rate of 20 autoinjectors per minute. Any out-of-specification products will then be segregated by a nest sorting system.
"The devices will be deposited by robot on to a circular conveyor belt that takes them through the X-ray machine," said Sapphire founder and CEO Richard Parmee. "So it was crucial to ensure the conveyor belt couldn't shed particles that could compromise the ISO class 7 clean room at the manufacturing facility. Our technology also needs to communicate with the nest sorting system – a challenge we are familiar with, as we often have to seamlessly include additional process equipment in our solutions."
Sapphire Inspection Systems has a range of more than 40 X-ray inspection machines designed for pharmaceutical, food and cosmetics production lines. But the company also creates bespoke solutions for specific challenges, such as the Oval project.
"Sapphire Inspection Systems was the obvious choice for this demanding project as it has a 20-year track record of working on complex challenges in the medical device and pharmaceutical sector," said Mike Savill, director of industrialisation at Oval Medical Technologies.
"The motorised laboratory X-ray machine completed last year will be an invaluable capability in our autoinjector design and development work – enabling us to understand prototype internal mechanisms and check every last detail without disassembling the sample. The new inline machine is now set to bring the same level of capability to the production line and ensure the highest levels of product quality."
