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HCT / TOC Analysis - Cleaning Process Validation for Medical Devices
Why have the cleaning processes of your medical devices validated?
The cleaning process is a crucial step in the manufacturing process of medical devices. It can be the last step before packaging and is intended to control the level of contamination of medical devices. It is therefore essential to validate this cleaning step in order to verify that the product in question meets the specifications. The implementation of the cleaning process is based on the search for contamination during the following stages: manufacturing and packaging. The manufacturer must therefore determine the materials and characteristics of the medical device (geometry, dimensions, porosity, surface condition, materials, etc.), list the manufacturing stages of the implant and identify potential contamination, taking into account the control and storage stages, contamination generated by packaging items and operator handling. The XP S94-091* standard establishes the recommended procedures for the cleaning of orthopedic implants before final packaging, which will make it possible to guarantee and validate physicochemical and microbiological cleanliness. This document defines the minimum characteristics to be verified and proposes acceptance criteria for cleaning validation.
FILAB is the first laboratory to be COFRAC ISO 17025 accredited for the analysis of cleaning residues on Medical Devices. FILAB has the skills and high-level analytical resources to offer you its analytical services dedicated to medical devices in accordance with the NF S94-091 standard and adapted to the identification and quantification of organic and mineral pollution that may be present on your medical devices:
Analysis and determination of total hydrocarbons HCT on medical devices by GC/FID according to NF EN ISO 9377-2,
Determination of inorganic residues on medical devices according to ISO 19227 by ICP AES and/or ICP MS
Analysis and determination of total organic compounds (TOC) on medical devices according to the NF EN 1484 standard,
Validation of cleaning processes according to ISO 19227:2018
FILAB also assists you with the following services:
Biocompatibility study according to ISO 10993 ( -18 / -12 / -13 / -14 / -15 / -19 / -22 )
Problem solving: non-conformity, breakage, adhesion, corrosion...
R&D support: custom chemical analysis, material and surface characterization, analytical development
For more information, contact our expert Caroline KURZAWA: firstname.lastname@example.org
*standard available on the website www.boutique.afnor.org