On the subject of "cleanliness of implants" both consulting services and chemical analyses are offered. We advise our clients on cleaning issues and process validations. We support you from the planning of the validation studies to the final report. In addition, we assess or develop risk analyses, evaluate the IQ and OQ documents or conduct performance qualification (PQ) studies, including the preparation of customized test specimens, appropriate staining and chemical analysis.
Standard component cleanliness analyzes regarding particles (residual soiling). Preparation of cleanliness test procedures (decay measurements, blank values, number of measurements, purging parameters, filters). Gravimetric measurements, determination of the total mass of all particles on the component (residual soiling). Light-optical analysis, counting and measurement as well as classification of the particles into metallic and non-metallic particles and fibers. Extensive analyzes, material identification of particles and analyzes by means of SEM / EDX or FT-IR.
Equipment: Stainless steel vacuum filtration unit Sartorius / Contamination Test Unit Hydac CTU 1040 / Analytic balance Mettler AX 205 / Automatic Filter Analysis System Jomesa HFD4 / Scanning Electron Microscope Zeiss Sigma 300 VP with EDX Analysis (AZtecFeature with x-Max 50 Detector) / FT-IR Microscope Bruker Lumos
Please read more on «Testing of technical cleanliness according to VDA 19 Part 1» in our Newsletter No. 28