Food & Medical Compounds
Rubber compounds which are designed to come into contact with food and drug applications will need to be formulated with FDA compliant raw materials to FDA 21 CFR 177.2600 Indirect Food Additives: Polymers; Subpart C – Substances for use only as components of articles intended for repeated use. All of these compounds will be made in accordance with EN 1935:2004. We also have experience of compounding USP Class VI compounds which can be used in the pharmaceutical industry.
Compounds which are formulated using only raw materials from the permissible list can be used for applications involving dry foodstuffs. For applications which involve aqueous or fatty foodstuffs, a series of extraction tests, often on the finished part, will need to be performed at an FDA accredited test laboratory.
Whilst Clwyd Compounders is not an FDA accredited test laboratory, we are able to perform indicative tests to give our customers confidence that the compound they purchase from us is likely to pass such extraction tests.
Another requirement for rubber compounds in the food and medical industry is the ability to identify and remove any rubber contamination. We can supply metal detectable compound that also complies with FDA, to ensure that early detection and removal can be made to ensure any potential contamination doesn’t reach the supply chain.