CleanControlling Medical GmbH & Co. KG offers a comprehensive portfolio of laboratory services as a GLP-certified, DIN EN ISO / IEC 17025 accredited and ZLG-approved test laboratory for biological and microbiological-hygienic testing of medical devices.
The range of services includes tests to determine the biocompatibility according to the amendment of DIN EN ISO 10993-1, tests for the validation and monitoring of cleaning processes, determination of particulate cleanliness, tests within the validation of reprocessing and sterilization instructions, life tests as well as tests for determination the chemical surface cleanliness.
In addition to the biological and microbiological-hygienic competences, there is a special focus on tests for the determination of particulate cleanliness. Due to the company's origin of CleanControlling GmbH in the area of "Technical Cleanliness" in industry and automotive, CleanControlling Medical GmbH & Co. KG relies on the comprehensive know-how from different methods for analysis, typification and characterization of particles as well as on the profound knowledge of cleanliness in industrial production processes.
using an optical particle counter (OPZ) based on USP 788 or
microscopic evaluation according to VDI 2083 sheet 21 *, DIN EN ISO 16232 * or USP 788.
Validation of preparation and sterilization processes
Tests as part of the validation of the manufacturer's information in reprocessing instructions for reprocessing and sterilization processes of medical devices according to DIN EN ISO 17664 and ISO 17665-1 for