Laboratory analysis of cleaning residue found on Medical Devices in accordance with the ISO 19227 standard
The FILAB laboratory supports manufacturers in the characterization of cleaning residues according to ISO 19227 and the interpretation of analytical results.
This standard defines an integrated methodological approach linking cleaning process validation, biological evaluation, and sterilization validation of medical devices.
Would you like to carry out a cleaning residue analysis on your medical devices according to ISO 19227?
ISO 19227:2018 Standard for medical devices: what is it about?
The international standard ISO 19227:2018, published in March 2018 and entitled “Surgical implants — Cleanliness of orthopaedic implants — General requirements”, sets out the requirements relating to the cleanliness of orthopaedic implants as well as the validation of the cleaning processes used.
Purpose of ISO 19227
The purpose of cleaning validation under ISO 19227:2018 is to verify the effectiveness of the cleaning process in reducing physical contaminants (and therefore particulate), chemical and microbiological contaminants below a level defined by the customer.
Call on FILAB, an ISO 19227 analysis laboratory for cleaning residue expertise
FILAB COFRAC 17025 accredited for ISO 19227 analysis
The FILAB laboratory is accredited by COFRAC ISO 17025 (www.cofrac.fr), according to validated and documented methods, helping you bring your activities into compliance with the requirements of ISO 19227 for your metal, ceramic and polymer medical devices.
Organic contaminant analysis
Inorganic contaminant analysis
Particulate contamination analysis
Particle counting according to AAMI TIR42, USP 788/789, PE 2.9.19 (methods 1 and 2)
ISO 19227: Cleaning residue and associated contamination analysis
Organic contaminant analysis: identification and quantification of organic residues: detergents, solvents, cleaning agents, process residues, or carbon-based compounds (HCT, TOC).
Organic contaminant analysis: identification and quantification of organic residues: detergents, solvents, cleaning agents, process residues, or carbon-based compounds (HCT, TOC).
Inorganic contaminant analysis: detection and quantification of inorganic residues such as metals, mineral salts, or trace elements from cleaning or manufacturing processes.
Inorganic contaminant analysis: detection and quantification of inorganic residues such as metals, mineral salts, or trace elements from cleaning or manufacturing processes.
Particulate contamination analysis : characterization of residual particles present after cleaning: size, nature, morphology, and distribution, in line with the cleanliness requirements for medical devices.
Particulate contamination analysis : characterization of residual particles present after cleaning: size, nature, morphology, and distribution, in line with the cleanliness requirements for medical devices.
Validation of analytical methods according to ISO 17025: development, adaptation, and validation of cleaning residue analysis methods, including analytical performance, sensitivity, and repeatability, within the framework of ISO 19227 requirements.
Validation of analytical methods according to ISO 17025: development, adaptation, and validation of cleaning residue analysis methods, including analytical performance, sensitivity, and repeatability, within the framework of ISO 19227 requirements.
Analytical method validation
Why carry out an ISO 19227 analysis?
Why choose FILAB for your ISO 19227 analysis?
In France, in the medical device sector, FILAB is one of the few laboratories with a complete analytical platform for carrying out cleaning residue analysis. These services draw on expertise in chemical analysis, both organic and inorganic, and in materials characterization of device components, such as metal alloys, ceramics, and polymers.
At the FILAB laboratory, analysis are carried out using methods developed and validated according to ISO 17025, in line with ISO 19227, with protocols adapted to the materials, cleaning agents, and real-world conditions of industrial processes.
The steps involved in carrying out analysis according to ISO 19227
A comprehensive review of the risk analysis related to cleaning. Risk management is an iterative process that must be carried out by the client throughout the design, validation, and use of the cleaning process.
The design of a cleaning process based on the implant’s characteristics, its expected performance, and its manufacturing steps.
The definition of minimum cleanliness criteria after final cleaning
The validation of cleaning methods for each type of implant
L’évaluation biologique selon l’ISO 10993-1 et validation du procédé de stérilisation
As part of this approach, the FILAB laboratory supports companies in the chemical analysis of cleaning residues (HCT/COT organic contaminants, inorganic and acidic residues, particulate contaminants) on medical devices.
FAQ
Cleaning validation in the pharmaceutical industry aims to demonstrate, through appropriate analysis, that cleaning processes effectively remove residues of active ingredients, excipients, detergents, or contaminants in order to ensure product safety and regulatory compliance.
Cleaning validation for Medical Devices makes it possible to verify the removal of residues from manufacturing and cleaning processes, in order to control biological risk before sterilization, in accordance with normative and regulatory requirements.
A DM cleaning analysis carried out in a laboratory makes it possible to identify, quantify, and characterize cleaning residues present on medical devices, in order to validate process effectiveness and support compliance documentation.
An ISO 19227 laboratory supports manufacturers in ISO 19227 analysis by establishing the link between cleaning validation, biological evaluation, and sterilization validation, notably through residue analysis tailored to medical devices.
A cleaning residue lab can analyze detergent residues, solvents, cleaning agents, organic or inorganic contaminants, as well as specific residues linked to industrial processes or device materials.
A cleaning residue analysis laboratory provides advanced analytical expertise for trace-level detection, reliable residue quantification, and interpretation of results in a pharmaceutical or medical device regulatory context.
An HCT COT assessment makes it possible to measure the residual organic load resulting from cleaning processes. This approach is commonly used for cleaning residue characterization and the overall assessment of surface cleanliness.
The FILAB laboratory is COFRAC ISO 17025 accredited. This accreditation attests to the laboratory’s technical competence for carrying out cleaning residue analysis in compliance with the requirements of ISO 19227.
To obtain a quote for a cleaning residue analysis, our contact form is available.
The quote for ISO 19227 analysis on Medical Devices is generally sent within 24 to 48 hours after receipt of the request via the form.
