RondelO™ is made by injection moulded plastic and consists of only two parts, a house part and a handle part that together become the RondelO™ turn valve. Within this project, a multicavity injection mould tool has been developed and reduced the COGS drastically. The complex design of the RondelO™ house part requires up to 8 moving cores to form the drug inlets of the RondelO™ turn valve. All these cores requires individual cooling to be able to form the RondelO™ house part with tight tolerances to be compliant with the Luer standard ISO 80369-7, meanwhile keeping the cycle time low to avoid degradation of the plastic material used. The Co-polyester used to mould the RondelO™ house part is superior in its properties to withstand drugs that will be used in for example in an oncology setting, but it requires some special attention during the manufacturing process.
To be able to assemble the RondelO™ house and handle part to form a complete turn valve, an automation for the assembly was developed. It has an in-process quality control of all parameters such as measuring mounting force, torque force, leakage and marking a unique QR code on each individual RondelO™, meanwhile having a production output capacity of 1 RondelO™ per second. All these testing parameters are saved and can be fetched by scanning the QR code at any time.
A modular cleanroom was designed where the RondelO™ automation will be placed and thereby it completes our own in-house Quality Control center.
The project supported the development of a range of Final Device IV-sets with certification that will be introduced to the market to make adoption happen of the larger companies that dominates the market. Also, indications from early market communications are that the larger players appreciate that going all the distance from development of a new product to certification differentiates our company from many others and it actually helps them to achieve their potential implementation of RondelO™ faster.
