Laboratory analysis of extractables and leachables (E&Ls)
Your needs : to analyze extractables and leachables present in your materials to evaluate the conformity of health products with standards
Analysis of extractables and leachables (E&Ls) allows for the risk of a substance migrating from a container to its contents to be assessed. This mostly applies to the pharmaceutical, cosmetics and medical device industries.
Studies of extractables or leachables can be done on different types of materials or compounds : polymer additives, plasticizers, stabilizers, colorings, metallic catalysts and other chemical substances posing a contamination risk to a product.
Any substance susceptible of comping into contact with a product during the production process or at any point all the way till the implementation of the finished product must be subject to rigorous analyses and inspections to confirm that said substance has not contaminated the product.
Our solution : to carry out compatibility analyses between containers and contents and to analyze potential substance migrations
With a varied analytical fleet and dual expertise in chemistry and materials science, the FILAB laboratory can assist you at each step of the evaluation process of extractables and of leachables in health products (medical devices, pharmaceutical products, cosmetic products) by providing the following services :
- Chemical analysis
- Literature reviews and drafting of a custom study schedule for analyzing extractable and leachable substances
- Heavy metal analysis
- Analysis of additives
- Qualitative and quantitative analyses of extractables in Medical devices – material characterization in accordance with ISO 10993-12 and 10993-18
- Qualitative and quantitative analyses of leachable substances (organic and inorganic analyses : volatile, semi-volatile and non-volatile substances)
- Degradation product and leachable substance analysis of medical devices
- Chemical characterization of materials in Medical devices in accordance with ISO 10993-18 : polymers, ceramics, metallic parts
- Analytical development and validation of a new technique
- Stability and compatibility analysis of extractables and leachables
- Interaction testing between a container and its contents (Migration testing)
- Packaging analysis
With three levels of services – analysis, expertise and R&D support – FILAB assists companies from all sectors and of all sizes in overcoming their industrial challenges by sharing its technical know-how and the wealth of experience of its team with its clients.
FILAB can also provide the following services :
Biocompatibility analyses in accordance with the ISO 10993 set (-18 / -12 / -13 / -14 / -15 / -19 / -22)
Validation of procedures : Cleaning (ISO 19227 set), surface treatment
Problem solving : non-conformities, ruptures, adhesive problems, corrosion…
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
(Litters available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 2100m²
A SAFRAN approval