22 - 24 October 2019
BIOLOGICAL TESTSIn-vitro cytotoxicity test as per DIN EN ISO 10993-5Determination of bioburden including validation as per DIN EN ISO 11737-1Endotoxin test (LAL test) as per USP 85/ Ph. Eur. 2.6.14Sterility test as per DIN EN ISO 11737-2Evaluation of contact plates for microbiological environment monitoringPARTICULATE TESTSParticulate contamination testing using an optical particle counter (OPC) based on USP 788 or microscopic evaluation based on ISO 16232 or USP 788.FURTHER TESTSChemical analyses, e.g. GC-MS, LC-MS , TOC , THC , ICP-MS/Headspace-GC-MSIn vitro pyrogen test (IPT)Testing of the product surface, e.g. REM/EDX, XPSVALIDATION OF REPROCESSING AND STERILIZATION PROCESSESTests 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 formanual or automated processing of medical devicessteam sterilization of medical devicesVALIDATION OF FINAL CLEANING PROCESSTests within the validation of the final cleaning of medical devices:In-vitro cytotoxicity test acc. DIN EN ISO 10993-5Examination of particulate contamination based on USP 788TOC and THC determinationDetermination of bioburden acc. DIN EN ISO 11737-1Endotoxin test (LAL test)BIOCOMPATIBILITY OF MEDICAL DEVICESTests to determine biocompatibility of medical devices according to the amendment of DIN EN ISO 10993-1:In-vitro cytotoxicity test acc. DIN EN ISO 10993-5Sample preparation for biological and chemical evaluation of medical devices acc. DIN EN ISO 10993-12Chemical characterization acc. DIN EN ISO 10993-18: GC-MS / THC / ICP-MS / LC-MS / Headspace-GC-MSToxicological short evaluationToxicological / biological evaluation of chemical analysis of medical devices according to DIN EN ISO 10993-17
Novel, supplementary test method for the testing of surface cleanliness by means of suction extraction (air) by suction of dry and adhesive particles of large surfaces ...
Analyzes for the determination of chemical-filmic surface contamination
- Testing the wettability by determining the surface tension ...
Cleanliness inspections acc. VDA 19.1 /
ISO 16232-3/4/5/6/7 and 10 as well as over 600 specific customer standards
- Standard cleanliness inspections
- CCPlus cleanliness ...
customer-oriented, targeted consulting and support for:
Technical Cleanliness Assessment in Production
Audit / Potential Analysis
Monitoring accessories for assessing particle appearance in the production environment, including using particle traps or stamps.