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 analysis and inspections to confirm that said substance has not contaminated the product.
Our solution :container/content compatibility tests and analysis of potential migration of extractables and releargables.
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 analysis of extractables in Medical devices – material characterization in accordance with ISO 10993-12 and 10993-18
- Qualitative and quantitative analysis of leachable substances (organic and inorganic analysis : 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 analysis 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…
Extractables and leachables testing is a critical aspect of biocompatibility testing for medical devices, pharmaceuticals, and packaging materials. Different types of machines and equipment are used in the laboratory to conduct this testing. The choice of equipment depends on the specific requirements of the testing and the characteristics of the sample being analyzed.
The following are some examples of the methods commonly used for extractables and leachables testing:
- Gas chromatography-mass spectrometry (GC-MS): GC-MS is a highly sensitive analytical method that can identify and quantify the presence of trace-level volatile and semi-volatile organic compounds in a sample. This technique is often used for extractables testing.
- High-performance liquid chromatography (HPLC): HPLC is a widely used analytical method that separates, identifies, and quantifies individual components in a sample. It is often used for leachables testing.
- Inductively coupled plasma mass spectrometry (ICP-MS): ICP-MS is a sensitive technique used to detect and quantify trace amounts of inorganic elements present in a sample. It is often used for extractables and leachables testing of metal-containing medical devices.
- Fourier-transform infrared spectroscopy (FTIR): FTIR is a non-destructive technique that detects and identifies chemical bonds and functional groups present in a sample. It is commonly used for identification and characterization of extractables and leachables.
- Liquid chromatography-mass spectrometry (LC-MS): LC-MS combines the separation capabilities of HPLC with the detection capabilities of mass spectrometry. It is often used for the analysis of polar and non-volatile compounds.
Extractables and leachables testing is used in various sectors, including pharmaceuticals, medical devices, and packaging.
- In the pharmaceutical industry, extractables and leachables testing is necessary to ensure that the materials used in drug products, such as syringes, vials, and IV bags, do not introduce any harmful substances into the product. This type of testing is required by regulatory bodies to ensure the safety and efficacy of drug products.
- In the medical device industry, extractables and leachables testing is essential to determine whether the device materials are compatible with the body and safe for use. This testing is particularly important for implantable medical devices, such as pacemakers and artificial joints, where the device materials can potentially leach into the surrounding tissues.
- In the cosmetics sector, extractables and leachables testing is performed to ensure the safety and quality of products. It is essential for identifying any potential chemical compounds that may leach or migrate from the packaging or device used to store or apply the cosmetic product, which could potentially impact the safety and efficacy of the product. Cosmetic products undergo extractables and leachables testing to comply with regulatory requirements, such as the European Union Regulation on Cosmetic Products (EC) No. 1223/2009, which requires manufacturers to ensure that cosmetic products are safe for human health and do not pose any risk to consumers.
- In the packaging industry, extractables and leachables testing is necessary to ensure that the packaging used for food, beverages, and other consumer products does not introduce any harmful substances into the product. This testing helps to ensure that the packaging materials are safe and pose no risk to human health.
The requirement for extractables and leachables testing depends on the type of product and regulatory agency involved. In many cases, extractables and leachables testing is mandatory, especially for medical devices and pharmaceutical products, to ensure product safety and regulatory compliance.
For example, the US FDA requires medical device manufacturers to conduct biocompatibility testing that includes extractables and leachables testing as part of the regulatory approval process. The European Medicines Agency (EMA) also requires pharmaceutical companies to conduct extractables and leachables testing as part of the drug registration process.
Similarly, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recommends that pharmaceutical companies conduct extractables and leachables testing as part of the drug development process.
