Medical Devices and Medicinal Drugs

A failure or latent flaw in implants and medical devices and medicinal drugs could result in serious adverse effects on human health so that data related to the safety of implants, medical devices, and medicinal drugs have to be filed to the regulatory agencies in Japan before use.

JEF-TEC can perform the elution test of materials used in medical devices and in implants for judging the biocompatibility of the materials and the analysis of impurities in medicinal drugs and supports the clients for preparation of relevant documents to submit to the regulatory agencies for approval as well as for implementation of a research and development program.

Chemical Evaluation of Implants and Implant Materials

The implant materials could leach out after implantation in the body and characterization of the eluted substances in the usage environment and the material to be used for implants is therefore essential in a stage of research and development of implants, and appropriate collection of data for filing the relevant document to the regulatory agencies in Japan for approval is a must before commercialization.

JEF-TEC can service the client needs with an elution test of the implant materials under various conditions and the evaluation of the implant materials by various analytical method.

Analysis of Impurities in Medicinal Drugs

Impurities in medicinal drugs and catalyst residues in drug manufacturing processes could cause unwanted side effects and serious health risks.

JEF-TEC also services the analysis of the impurities, foreign particles, and trace contaminants according to the ICH Q3D Guideline to support the client needs for collecting and managing data.

Elution Test and Evaluation Test of Medical Devices

The in-vivo medical devices such as stents and medical needles have to be tested to identify the leaching substances from the devices for managing data.

JEF-TEC performs the tests in accordance to the method specified in each medical device for controlling the leaching substances.

Analysis of Pharmaceuticals and Personal Care Products as Pollutants (PPCPs) Released into the Environment

Sedatives and antibiotics are commonly used and very important substances for everyday life, and when released their effects on the environment as major sources of Pharmaceuticals and Personal Care Products as Pollutants (PPCPs) are not well understood yet.

JEF-TEC can service the clients the characterization of the components of PPCPs by high resolution GC-MS and liquid chromatography mass spectrometry (LC-MS).

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