In order to implement the Clean Production Promotion Law of the People's Republic of China, guide and promote chemical raw material pharmaceutical enterprises to implement clean production in accordance with the law, improve resource utilization, reduce and avoid the generation of pollutants, protect and improve the environment, * the "Evaluation Index System for Clean Production in the Chemical Raw Material Pharmaceutical Industry (Draft for Comments)" has been releasedNew requirements will be imposed on the production of raw material pharmaceutical enterprises.

The indicator system divides the level of clean production into three levels,Level I is the level of clean production; Level II is the domestic level of clean production; Level III is the general level of clean production in China.

Target audience of the indicator system: Production enterprises that use synthesis, extraction, fermentation and other methods to prepare chemical raw materials.

The evaluation indicators are divided into six categories:① Production process and equipment indicators, ② resource and energy consumption indicators, ③ comprehensive resource utilization indicators, ④ pollutant generation indicators, ⑤ product characteristic indicators, and6 clean production management indicators.

Items that may be related to analysis and testing in the evaluation criteria:

Shimadzu's analytical instrument product line is very comprehensive, covering a full range of products from conventional chromatography, spectroscopy, to mass spectrometry. It can not only meet the needs of conventional teaching and scientific research, but also meet the needs of industries such as environmental protection, online monitoring, and drug production research and development. Shimadzu and ChinamajorCollaborating with research institutions in the field of environmental protection, we jointly develop analytical and testing methods covering areas such as water bodies, soil, atmosphere, wastewater, solid waste, volatile organic compounds, etc., providing a complete laboratory for clean production, resource utilization, and environmental protection/Online monitoring solution.

Volatile Organic Compounds Solution

A large amount of solvents are required in the production of active pharmaceutical ingredients, and the components in raw materials, as well as the products and waste from synthesis, fermentation, extraction, etc., may all become sources of volatile organic compounds. Therefore, monitoring and utilization are necessary. Gas chromatography or gas chromatography-mass spectrometry for detection, onlineVOC device for testing. Select suitable pre-treatment methods based on different samples, such as digital canister sampling combined with gas pre concentration device for gas samples, solid adsorption sampling combined with thermal desorption (TD) injection, etc. For liquid and solid samples, solvent extraction or headspace injection (HS), blow and capture, etc. can be used.

Solution for heavy metal elements

Pharmaceutical residues, soil, pharmaceutical solid waste, water quality/Shimadzu provides detection technologies such as AA, UV, ICP, and ICPMS for heavy metal element detection in wastewater. From the perspective of improving detection efficiency, we first use EDX (Energy Dispersive X-ray Fluorescence Spectroscopy) technology. This technology does not require sample pre-treatment, and can preliminarily determine the type and approximate content of elements contained in the sample, screen out toxic, harmful or needed elements, and then accurately quantify the elements of interest.

Solution for toxic and harmful substances

For non-volatile toxic and harmful substances, they are usually usedLC and LCMS perform precise testing to ensure that materials are properly disposed of. If encountering unknown components, consider using LC-QTOF high-resolution mass spectrometry to accurately determine the components and then quantify them accurately

Online monitoring solution

Projects that require continuous monitoring in the production process of active pharmaceutical ingredients, such as ammonia nitrogenCOD、VOC， *Use Shimadzu online monitoring equipment: online ammonia nitrogen analyzer, online COD analyzer, online total organic carbon analyzer, etc.

Shimadzu Laboratory's testing product technology and online monitoring product technology provide strong support for the construction of clean production evaluation system for raw material pharmaceutical production enterprises, and more technologies are needed/For product information, please contact Shimadzu!