About CleanControlling Medical
CleanControlling Medical stands for comprehensive expertise in the field of biological and microbiological hygienic testing of medical devices. The intensive exchange with the parties involved in approval procedures and the clear understanding of customer requirements ensures targeted testing strategies.
As an accredited (acc. DIN EN ISO / IEC 17025), certified (GLP) and approved (ZLG) testing laboratory, CleanControlling Medical offers a full range of high-quality laboratory services.
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.
The new European Medical Devices Regulation (EU-MDR) leads to changes in the classification of medical devices by risk classes. These changes mean a recertification of products for a large number of medical device manufacturers, which must be available by the end of the transition period on 26 May 2020. The necessary risk assessments, audits and documentation increasingly present major organizational and temporal challenges to manufacturers and consultative and auditing bodies.
CleanControlling Medical has adapted to the challenges and prepared itself with accredited testing procedures as well as the necessary testing capacities and the expansion of the laboratory infrastructure with around 500 m² of laboratory premises and with state-of-the-art equipment. The expansion and furnishing of the laboratory premises were implemented and accredited end of 2018.
CleanControlling Medical – Specialist in particle testing
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 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.
The extensive experience gained in laboratory analysis in the area of technical cleanliness is also the important basis for efficient laboratory management with the highest standards of quality, reliability and short processing times required in the automotive sector.
Particulate contamination testing using
- optical particle counter (OPC) based on USP 788
- microscopic evaluation based on VDI 2083-21, ISO 16232 or USP 788.
Biocompatibility of medical devices
Tests to determine biocompatibility of medical devices according to the amendment of DIN EN ISO 10993-1
- In-vitro cytotoxicity test acc. DIN EN ISO 10993-5
- Sample preparation for biological and chemical evaluation of medical devices acc. DIN EN ISO 10993-12
- Chemical characterization acc. DIN EN ISO 10993-18: GC-MS / THC / ICP-MS / LC-MS / Headspace-GC-MS
- Toxicological short evaluation
- Toxicological / biological evaluation of chemical analysis of medical devices according to DIN EN ISO 10993-17
Validation of final cleaning process
Tests within the validation of the final cleaning of medical devices
• In-vitro cytotoxicity test acc. DIN EN ISO 10993-5
• Examination of particulate contamination based on USP 788
• TOC and THC determination
• Determination of bioburden acc. DIN EN ISO 11737-1
• Endotoxin test (LAL test)
Validation of reprocessing and sterilization processes
Tests within the validation of information in processing instructions provided by the medical device manufacturer for reprocessing and sterilization processes acc. DIN EN ISO 17664 and ISO 17665-1 for
- manual or automated processing of medical devices
- steam sterilization of medical devices
- simulation of processing cycles of medical devices
- In-vitro cytotoxicity test as per DIN EN ISO 10993-5
- Determination of bioburden including validation as per DIN EN ISO 11737 1
- Endotoxin test (LAL test) as per USP 85/ Ph. Eur. 2.6.14
- Sterility test as per DIN EN ISO 11737-2
- Evaluation of contact plates for microbiological environment monitoring