Cikautxo Medical is to begin serial production of three new micro-moulded liquid silicone rubber (LSR) valves for tracheostomy cannula applications. They have been specifically developed in close collaboration with a European OEM company to significantly improve the comfort of the patient.
According to Cikautxo, the fully biocompatible LSR micro-parts assure the sealing function as well as being attractive to look at and in a bright colour. With this new product range Cikautxo Medical is aiming to strengthen its LSR micro-moulding expertise for silicone parts below 0.5 grams and very tight tolerances. The production process has been fully robotised in the cleanroom manufacturing facilities of the headquarters which are located in the north of Spain. The company plans to expand its current moulding cleanroom facility area with the purchase of a new micro-injection machine this year.
The company has much experience in polymer contract manufacturing products using specific machinery for medical short-term applications or long-term implants. Cleanroom manufacturing conditions are used as per ISO 14644-1/2 standards and also cGMP manufacturing standards. In addition, the company has dedicated cleanrooms for each technology, for improved control and traceability of each specific product line.
A specific ISO 7 cleanroom (FDA class 10000) is used exclusively for extrusion technology. Due to the high demand in polyurethane catheters manufacturing that Cikautxo is currently experiencing, it has recently installed a new moisture control system in its catheters manufacturing cleanroom to help guarantee increasing manufacturing process