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Cleaning residues analysis on Medical Devices according to standard ISO 19227: 2018
ISO 19227: 2018 standard
The international ISO 19227 : 2018 standard, published on march, 2018 and whose the name is “Implants for surgery -- Cleanliness of orthopedic implants -- General requirements”, specifies requirements for the cleanliness of orthopedic implants, and test methods for the cleaning process validation.
Based on ISO 19227:2018, an efficient cleaning process allows to reduce physical, chemical and microbiological contaminants below a defined level. For that, the implementation of the ISO 19227 standard requires several steps to be set up by the manufacturers:
- A complete review of the risk assessment on the cleaning process (development, validation and processing methods).
- A specific method development based on implant characteristics, the steps of manufacturing and the expected performance
- The definition of minimum cleanliness requirements after final cleaning
- A validation of cleaning methods for each implant
- A biological evaluation according to ISO 10993-1 and a validation of the sterilization process
In this case, our laboratory assists medical companies in the chemical analysis of cleaning residues on Medical Devices Implants :
- Total HydroCarbons THC analysis by GC
- Total Organic Content TOC analysis
- Elemental impurities chemical analysis by ICP-AES and ICP-MS
- Inorganic and acid residues chemical residues by Ion Chromatography IC
- Particulate contaminants by SEM and Microcoscopy Characterization
Analysis of cleaning impurities according to ISO 19227:2018, how does FILAB laboratory help you ?
FILAB laboratory proposes a wide range of analytical services on medical devices, according to validated and documented methods, to help you to align your activities with the requirements of the ISO 19227: 2018 standard.
With an analytical park of 2,200 m² and high skills human competences, FILAB laboratory carries out the following analyses, within the framework of the ISO 19227: 2018:
o Quantitative analysis of organic contaminants
- Analysis of total hydrocarbon residues (HCT) by GC-FID
- Quantification of Total Organic Carbon (TOC) by TOC-meter
o Quantitative analysis of inorganic contaminants in the laboratory
- Analysis of heavy metal residues by ICP-AES or ICP-MS
- Analysis of detergent residues by ICP-AES or ICP-MS
- Analysis of mineral acid residues by IC
o Quantitative analysis of particulate contamination in the laboratory
Several kinds of technics (Optical Microscopy, Electron Microscopy SEM ...) and methodologies (European Pharmacopoeia ...) can be used for the particle counting according to the ISO 19227 standard and carried out by FILAB laboratory.
o Analytical methods validation according to ICH Q2
- Exhaustive extraction method avalidation according to ISO 10993-12
- Routine Method analysis
Why FILAB Laboratory:
FILAB was the first laboratory to have been accredited ISO 17025 in France for THC and TOC analysis on Medical Devices, according to French standard NF S94-091 (the original ISO 19227 standard).
In international markets of Medical Devices, FILAB is also one of the only laboratories to provide you a complete analytical park (2100 m²) with both knowledge in chemical analysis (organic and mineral) but also in materials characterization (metal alloys, ceramics, polymers ...).
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a reliability of the results, a fast processing of the requests and personalized accompaniment.