Medical device manufacturer

From classic cleaning validation to research projects, our experienced team combines proven methods with pioneering technologies. This enables us to provide the best possible service for your individual requirements, giving you a decisive competitive advantage. Of particular note is our radioactive marking of test contamination (radionuclide method), which is ideal for localised investigations of possible critical points in instrument design. Thanks to our impressive range of equipment from various manufacturers, we can offer you a wide variety of laboratory services for cleaning, disinfection, sterilization and packaging validation — carried out precisely, efficiently and reliably.

Validation of the processes for reprocessing instructions

DIN EN ISO 17664

Validation of cleaning processes

DIN EN ISO 15883-5, ASTM FR3208-19, ST 98, Radioactive marking

Validation of thermal and chemo-thermal disinfection processes

DIN EN ISO 15883, FDA Guidances "Medical washers and medical washer-disinfectors"

Validation of sterilization processes with moist heat or VH₂O₂

EN ISO 17665-1, EN ISO 17665-2, ISO 14937

Testing for residual moisture after steam sterilization

DIN EN ISO 17665, ANSI/AAMI ST77, ANSI/AAMI ST79, ANSI/AAMI ST55, ANSI/AAMI ST08, DIN EN 868-8, DIN EN ISO 285, ISO 17664

Simulation of reprocessing cycles

End-of-life tests, artificial ageing

Available processing equipment

washer-disinfector, washer-disinfector for endoscopes, combination devices, VH₂O₂ sterilizer, EN 13060 sterilizer, EN 285 sterilizer, sealing devices, ultrasonic devices