The new system will help significantly speed up product release for shipment and is more than 5x faster than a previously semi-automated process that needed five different pieces of test equipment, each with its own specially-trained operator.
Innomech has integrated all five tests into one easy-to-use system with a total cycle time of less than one minute. The automated system requires just one operator, eliminates the need for any manual handling of auto-injectors between different tests and ensures all test results are fully recorded into a secure electronic record to comply with FDA 21 CFR part 11 regulations for medical device manufacturing.
“Innomech has designed a highly effective piece of automation to help Owen Mumford further improve test efficiency and process consistency, as well as enabling us to scale up production to meet growing demand for this particular drug delivery device. The Innomech system has also been designed to increase operator health and safety by eliminating previously repetitive manual tasks and the risks in handling fired pens,” said Steve Miles, manager of test methods & validation at Owen Mumford.
The operator starts the test cycle by inserting a complete auto-injector pre-loaded with its cartridge of active drug into the Innomech machine. The system then measures the forces required to remove the auto-injector’s safety cap and to fire the trigger, the dose time, volume of dose delivered and the distance the needle protrudes from the body of the device. The cycle ends with the fired device being automatically ejected from the machine into a sharps bin to protect the operator from the risk of any accidental scratches or puncture wounds.
If an auto-injector fails one of the five tests then the machine retains it, a red warning light is displayed and the operator receives an on-screen explanation allowing them to remove the product and to take further action as required.
Innomech has developed several systems for Owen Mumford over a number of years helping to optimise the assembly and test of the manufacturer’s own branded products, as well as customised devices that it manufactures for leading pharmaceutical companies.