You want to carry out analysis of extractables and leachables in accordance with FDA guidance
FDA guidance analysis of extractables and leachables is used to assess the risk of substances migrating from a container (packaging) to the contents (product). They are used in particular in the pharmaceutical, cosmetics and medical device sectors.
Extractables and leachables studies can be applied to several types of materials or compounds: polymer additives, plasticisers, stabilisers, colourants, metal catalysts and other chemicals showing a risk of contamination in the product.
What are extractables and leachables?
Extractables and leachables (E&L) are chemical substances that can be transferred from packaging materials, medical devices or production equipment to a finished product. These compounds, such as plasticisers, additives, residual solvents or degradation products, can alter the quality and safety of pharmaceutical, food or cosmetic products.
- Extractables: substances likely to be released when a material is exposed to extreme conditions (solvents, heat, etc.).
- Relargables: compounds which actually migrate into the final product under normal conditions of use.
What does the FDA say about extractables and leachables?
FDA guidelines emphasise the importance of designing robust extractables and leachables studies, including detailed study protocols, appropriate analytical procedures and toxicological evaluation of the substances identified. The aim is to ensure that materials used in manufacturing systems and container closure systems do not interfere with the safety, identity, strength, quality or purity of the product beyond established limits.
Why are FDA guidance E&L analysis essential?
Analysis of extractables and leachables in accordance with FDA guidance is crucial to guarantee :
- Regulatory compliance: meeting FDA requirements.
- User safety: identification and quantification of potentially toxic compounds.
- Product quality: prevention of undesirable interactions between materials and formulations.
These studies are essential for sectors such as :
- Pharmaceuticals: syringes, vials, infusion bags.
- Medical devices: implants, catheters.
- The food and cosmetics industries: packaging, containers.
FILAB performs extractables and leachables analysis according to FDA guidance
Why choose FILAB for FDA guidance analysis of extractables and leachables?
The FILAB laboratory is registered with the FDA and supports manufacturers who export their medical devices to the USA and who are required to have their products analysed by an FDA-registered laboratory.
FILAB provides medical device manufacturers with a high level of human expertise and state-of-the-art analytical equipment to offer them services that meet the compliance criteria imposed by the FDA.
Our analysis techniques for E&L according to FDA guidance
For research, identification and quantification of organic compounds present in solvents, anti-UV material additives, antioxidants, dyes, inks, detergent residues, sterilisation residues, polymer residues, etc., which have been extracted and/or released from the material by a standardised simulant.
For the determination of Chromium VI released by materials such as metal alloys
Particularly suitable for mineral or metallic contaminants or additives, such as heavy metals, mineral or metallic fillers, dyes, etc.
A fast, versatile diagnostic tool for diagnosing the surface condition of materials after ageing, and for observing particles, deposits, etc.
Our analysis services for extractables and leachables
