Neuraxial syringe barrels and plungers (disposable) for epidural anaesthesia (EDA)
In the process, the topic of materials played a central role – it was important that the types of plastic that would be used and the pad printing ink for the scale on the syringe barrel were already registered with the FDA (i.e. medical grade). This proved particularly challenging, as the customer wanted the plunger to be manufactured in two colours: plain and yellow. The objective was to meet the requirements of medical device class 1, including the entire production process and further finishing under controlled conditions. An important requirement for neuraxial applications (NRFit®) were new, non-interchangeable connectors. The barrel and plunger need to exhibit tight tolerances to each other. The greatest challenge was the ‘loss of resistance technique’ in order to achieve extreme sensitivity during use – the physician must be able to immediately feel the loss of resistance when the needle penetrates the epidural space through the syringe plunger.
This was followed by the reliable mass production and downstream pad printing of the syringe barrels, including quality control in the injection moulding and printing process. The barrels and two plunger versions (plain, yellow) were delivered directly to the contract packager in Italy specified by the customer, where the final siliconisation and assembly of the syringe also takes place.
The added value
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