Particles, technical cleanliness, VDA 19
Cleanliness of implants / cleaning validation
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.
Test of technical cleanliness VDA 19 part 1 / ISO 16232
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 Evo MA25 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
Residue Analysis on Implants
Analytical services for organic, inorganic and particulates are offered by RMS or in collaboration with external specialists. Typical methods applied for organic include GC-MS, LC-MS, or FT-IR analysis while for inorganic ICP-OES or XPS used. Gravimetric analysis (ASTM F2459) or SEM complement the methods regarding particulate materials.
Microbiological and biological analysis of implants are also performed. In particular, endotoxin analysis on implants are performed with based specific extraction protocols and kinetic turbidimetric or chromogenic LAL testing.
Cytotoxicity and cell testing is not part of the residue analysis program, but you are welcome do discuss your requests with us.