MedicalGroup provides cleaning and packaging services for all types of medical devices, thereby ensuring a high level of traceability throughout the manufacturing process.
On an automated and validated cleaning line, parts are cleaned in various solutions with monitored parameters (pH, concentration, ultrasound capacity).
The medical devices are then transferred to the ISO 7 clean room for inspection under ISO 5 laminar flow, are assembled if required, and then PETG blister or sachet sealed (tyvek, PA/PE, aluminium).
The parts leave the controlled atmosphere zone and are then labelled and packagedaccording to specifications.
Quality checks made in accordance with current standards (ISO 19227, ISIO 11607-1, ISO 14644) by our laboratory in cleaning baths (bioburden, endotoxins, TOC), in the clean room environment and on the sealings, ensure the highest level of quality control. .
MedicalGroup can also conduct specific product validations for its clients for cleaning and packaging processes.