Leachable Tests

Leachable tests are the analysis of potentially harmful materials administered to a patient with a drug or device. Pharmaceutical companies use these laboratory tests to evaluate whether chemicals have passed from production to medicine. Medical device companies have these tests done to prove that worrisome materials are not being transferred from the device to the patient.

Commonly applied analyzes concentrate on very low concentrations of chemicals. These test methods include atomic absorption spectroscopy for metals, gas chromatography for volatile materials, and liquid chromatography for non-volatile chemicals, followed by mass spectroscopic analysis to identify materials.

In short, all drug delivery devices and medical devices are tested for the presence of leachable substances. Toxicological assessments are then performed to measure a patient's exposure to each chemical and to quantify the level of risk posed by these materials.

The US Food and Drug Administration (FDA) defines leakability as compounds that leak into the drug product formulation from the container lid as a result of direct contact with the formulation. In the pharmaceutical environment, the passage of chemicals through all components of the packaging system must be considered. Materials from processing systems can also go into formulations. In some cases, it is not just the toxicity of these substances that is of concern. May affect the stability of drug active ingredients, especially biologics.

Leakable impurities can migrate from components in container closure systems, packaging systems, storage systems, process equipment and device packaging, affecting the overall purity and safety of the therapeutic product. These tests are important to identify potential sources of leaks.

The FDA defines leachables as organic and inorganic chemical species. They are inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drugs under normal use conditions. Sources of leachables can be stabilizers, antioxidants, coatings, emulsifiers, vulcanizing agents, lubricants, dyes and colorants. Pharmaceutical packaging, device packaging, container closure systems, drug delivery systems, and implantables can be complex combinations of polymer, rubber, glass, and other materials, all of which can contribute to the sealable profile of the product.

Our organization also provides leachable testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.