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  6. Evaluation of metal leaching from pharmaceuticals and food products.

Evaluation of metal leaching from pharmaceuticals and food products.

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last updated:Aug 02, 2017

JFEテクノリサーチ
JFEテクノリサーチ
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We will measure the elution amount under conditions suitable for the intended use.

The Importance of Metal Leaching Tests for Resin Materials ● Medical Devices and Materials Since these are implanted in the body or come into contact with biological systems for relatively long periods, it is necessary to not only meet standards corresponding to methods such as the "Pharmaceuticals and Medical Devices Agency's Plastic Pharmaceutical Container Test," but also to conduct leaching tests appropriate to the usage environment to identify leached elements and evaluate safety. ● Equipment and Packaging Used in Food Manufacturing and Processing Due to the potential for chemical substances leaching from these materials to contaminate food, it is necessary to confirm the presence or absence of metal components leaching using methods such as the "Standards for Food, Additives, etc. (Ministry of Health and Welfare Notification No. 370 of 1959)" and the "Standards for Resin Equipment and Packaging Containers (Ministry of Health, Labour and Welfare Notification No. 201)."

    Ingredient analysis
3S2J-155-00-01.jpg

Evaluation of metal leaching from pharmaceuticals and food products.

3S2J-155-00-01.jpg
3S2J-155-00-01.jpg
  • Related Link - http://www.jfe-tec.co.jp/implant/resin.html

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Analysis of trace leachate components ● High-resolution ICP mass spectrometer ppb level ultra-trace components ● Ion chromatography Anions such as halogens and sulfates - Pre-treatment and measurement will be conducted in a clean room. - Semi-quantitative analysis of over 60 elements will be performed using a quadrupole ICP mass spectrometer. - Accurate analytical values will be provided using various instruments such as ICP optical emission spectrometry and atomic absorption spectrometry, depending on the concentration.

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■Applications - Medical devices and materials - Instruments and packaging used in the manufacturing and processing of food ■Examples of Achievements Metal elution testing We conduct elution tests under simulated usage environments. - Ultrapure water - Various acids (dilute sulfuric acid, hydrochloric acid, acetic acid, etc.) - Alkalis - Saltwater, hydrogen peroxide, etc. We provide contamination-free analytical values by pre-treating in a cleanroom environment.

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Evaluation of metal leaching from resin materials used in pharmaceuticals, food, and semiconductors.

Evaluation of metal leaching from resin materials used in pharmaceuticals, food, and semiconductors.

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JFEテクノリサーチ

JFEテクノリサーチ

Testing, Analysis and Measurement

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To solve your technical challenges in a ONE-STOP manner, our team of 1,300 technical specialists will respond quickly and accurately while maintaining strict confidentiality. With bases in six locations nationwide, our experts in various fields utilize the latest analytical testing equipment to meet all your needs. We are confident that we can provide results that will satisfy you, and we would be grateful if you could give us a try.

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