Calmark’s fully automated production line was manufactured by the company Automationspartner in Ramlösa and completed on April 28. It was subsequently relocated to Calmark's production partner Frohe in Tyresö, where it was assembled and installed together with other equipment involved in the manufacturing process for the test cassettes. Staff from Automationspartner, along with staff from Calmark, have trained Frohe’s production staff to ensure safe handling and quality.
“I am very happy that the fully automated production line now is up and running. It has been a team effort, and many have contributed. I would like to thank Automationspartner, Frohe and those Calmarkers that have worked side by side to put everything in place,” says Anna Söderlund, CEO of Calmark. “This production update is a prerequisite for selling and delivering to major markets, such as India and China.”
Process validation is the method used to ensure the outcome of a series of production steps that together make up the manufacturing process. As regards medical devices, the process validation comprises the stages IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), in which the process limits and repetitiveness within production are verified.