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Laboratory analysis of cleaning residue found on Medical Devices in accordance with the ISO 19227 standard
What is the ISO 19227:18 standard in relation to Medical Devices?
The international ISO 19227:2018 standard, published in March of 2018, titled : “Implants for surgery — Cleanliness of orthopedic implants — General requirements” specifies requirements for the cleanliness of orthopedic implants, test methods for the cleaning process validation.
The end goal of validating cleaning procedures in accordance with the ISO 19227:2018 standard is to evaluate the efficiency of the procedure at reducing the presence of physical, chemical and microbiological contaminants to below a certain threshold, set by the client. In depth knowledge of the way an implant is manufactured is required to be able to evaluate cleaning methods and to be able to identify any potential contaminants or unwanted interactions between the implant and its environment…
The different steps of the ISO 19227 standard
Implementing the ISO 19227:2018 takes place over multiple steps which are preemptively carried out by the implant manufacturer:
- A complete risk assessment overview of the cleaning process. Risk management is a continuous process which must be handled by the client throughout the designing, validation and testing processes of a cleaning procedure
- A design of a cleaning process based on the characteristics of the implant, its expected performance and its manufacturing steps
- Determination of the minimum cleanliness threshold after the final cleaning process
- Validation of cleaning methods for each kind of implant
- Biological evaluation in accordance with the ISO 10993-1 standard and validation of the sterilization process
FILAB laboratory is able to assist companies in analyzing chemical residue (organic THC/TOC contaminants, inorganic and acidic residues, particulate contaminants) found on medical devices.
Analysis of cleaning residue in accordance with the ISO 19227:2018
FILAB laboratory provides a wide range of services, some of which are carried out under ISO 17025 accreditation following validated and documented methods, helping you ensure that your products conform with the requirements stated in the ISO 19227:2018 standard. (www.cofrac.fr)
Relying on a cutting-edge analytical fleet and a diverse skillset, FILAB is able to provide the following services in accordance with the ISO 19227:2018 standard :
Laboratory analysis of organic contaminants
Analysis of Total HydroCarbons (THC) by GC-FID
Measurement of Total Organic Carbon (TOC) by TOC-meter
Laboratory analysis of inorganic contaminants
Analysis of residual heavy metals by ICP
Analysis of residual inorganic acids by IC
Analysis of detergent residue by ICP
LABORATORY ANALYSIS OF PARTICULATE CONTAMINANTS
Various techniques (Optical Microscopy, Electron Microscopy…) and methodologies (European Pharmacopeia…) can be used to count particulates in accordance with the ISO 19227 standard.
Validation of analytical methods
Verification of the exhaustiveness of an extraction method
Why FILAB ?
In France and particularly in the field of medical devices, FILAB is one of a very few laboratories equipped to able to provide these services which require analytical knowhow (both in organics and inorganics) as well as skills in material characterization (metallic alloys, ceramics, polymers…).
FILAB laboratory was the first French laboratory to receive ISO 17025 accreditation for the analysis of THCs and TOCs in Medical Devices and Equipment in accordance with the French NF S94-091 standard.
FILAB is also able to provide the following services :
Biocompatibility testing in accordance with the ISO 10993 set ( 10993-18 / 10993-12 / 10993-13 / 10993-14 / 10993-15 / 10993-19 / 10993-22 )
Problem solving : non-compliance, ruptures, adhesive problems, corrosion…
R&D support : custom chemical analyses, material characterization, surface characterization, analytical development
The fact that we work on a human scale, our continuous investments and our knowledge of Medical Devices all guarantee the reliability of our results, a quick turnaround for requests and personalized support for our clients.