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 FTIR.
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
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 FTIR 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.
Standards on Reporting Implant Cleanliness
The ASTM standard practice F2847 on Reporting and Assessment of Residues on Single Use Implants has been recently issued byASTM international. It is the first standard that addresses the cleanliness of implants and it describes how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.
ASTM F2459 is a Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. It is a simple and straight forward test method to determine the extractable residues in metallic medical components. Extractable residues includes aqueous and non-aqueous residue, as well as non-soluble residues.
ASTM Workshop 2010 «How Clean is Clean Enough»
RMS Foundation, Cambridge Polymers and FDA organized on November 16th 2010 a workshop on ongoing issues of cleaning medical devices, including new implants and reusable devices, establishing limit values, legal implications, etc.
The program abstracts and the presentations of the meeting can be downloaded here.
Publications in the Journal of ASTM international on cleanliness
The journal of ASTM international (JAI) has published a few paper on issues related to implant cleanliness. JAI: cleanliness of implants.