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再添新指南!国家药监局公开征求《制药用水检查指南(征求意见稿)》
仪器信息网· 2025-07-17 04:42
Core Viewpoint - The article discusses the draft guidelines for the inspection of pharmaceutical water, emphasizing the importance of water quality in the pharmaceutical production process and its direct impact on drug quality and patient safety [3][5]. Summary by Sections Overview - Pharmaceutical water refers to various quality-standard waters used in the pharmaceutical production process, and its preparation and distribution systems are critical to drug quality, making it a high-risk public utility system [12][13]. Purpose - The guidelines aim to ensure drug quality and patient safety by providing a framework for quality risk management in the preparation of drinking water, purified water, injection water, and pure steam [14]. Scope - The guidelines serve as a technical reference for on-site inspections of drinking water, purified water, injection water, and pure steam systems used in pharmaceutical production [15]. Pharmaceutical Water Risk Management - Quality risk management should consider facility design, execution of well-designed procedures, and continuous compliance with expected results [16][17]. - Companies must minimize contamination risks and ensure water quality meets national standards and regulatory requirements [17]. - Risk management should encompass the entire process of pharmaceutical water, including design, preparation, usage, and monitoring [17]. Drinking Water Inspection Points - Drinking water should be sourced primarily from municipal supplies, with regular quality assessments and monitoring to ensure compliance with national standards [19]. Purified Water Inspection Points - The purified water system typically consists of a pre-treatment system and a purification system, with regular cleaning and monitoring required to meet quality standards [21][22]. - Key inspection points include system confirmation and validation, installation confirmation, operational confirmation, and performance confirmation [22][23][24]. Injection Water Inspection Points - Injection water is critical for the quality of sterile drugs, with distillation being the preferred method for its preparation [45]. - Non-distillation methods such as membrane separation and deionization can also be used, provided they meet equivalent quality standards [46].
工业和信息化部对《甲硫醇气体检测报警器校准规范》等128项行业计量技术规范报批公示
仪器信息网· 2025-07-17 04:42
邮编:100804 导读: 工业和信息化部公示128项行业计量技术规范报批稿,截止日期为2025年8月14日,如有异议可反馈至指定邮箱。 特别提示 微信机制调整,点击顶部"仪器信息网" → 右上方"…" → 设为 ★ 星标,否则很可能无法看到我们的推送。 根据工业和信息化部计量技术规范制修订工作的总体安排,现将审查后报批的《甲硫醇气体检测报警器校准规范》等 128项行业计量技术规范报批稿(附件1)予以公示,截止日期为2025年8月14日。如对报批的计量技术规范有不同 意见,请在公示期间填写《行业计量技术规范报批稿反馈意见表》(附件2)并反馈至工业和信息化部科技司,电子邮 件发送至huangx y@ces i .cn(邮件主题注明:计量技术规范报批稿公示反馈)。 地址:北京市西长安街13号 工业和信息化部科技司 工业和信息化部科技司 2025年7月15日 点击文末"阅读原文"查看附件 联系方式:010-68205243 公示时间:2025年7月15日-2025年8月14日 附件: 1.128项部门计量技术规范编号、名称、主要内容等一览表 2.行业计量技术规范报批稿反馈意见表 | 转 载 : 须 本 号 授 权 ...
市场监管总局就检验检测从业人员监管新规征求意见
仪器信息网· 2025-07-17 04:42
Core Viewpoint - The article discusses the draft of the "Supervision and Management Measures for Inspection and Testing Practitioners (Trial) (Draft for Comments)", which focuses on enhancing the supervision of personnel in the inspection and testing industry, clarifying responsibilities, standardizing behaviors, and strengthening credit management to establish a closed-loop regulatory system and maintain market order [2][3]. Group 1 - The draft aims to strengthen supervision over inspection and testing institutions and their personnel, emphasizing the importance of the "human" element in the industry [2][3]. - Practitioners are required to adhere to laws, regulations, and professional ethics, ensuring that inspection and testing processes are scientific, accurate, and traceable [2][3]. - The draft specifies that key positions such as technical and quality managers must possess relevant professional qualifications and be familiar with applicable laws and standards [3]. Group 2 - The draft establishes a management system for practitioners, including education and training, capability assessment, and credit evaluation, guiding institutions to fulfill their management responsibilities [3]. - A credit risk classification management system will be implemented, creating credit files for practitioners and enhancing the incentive and constraint mechanisms for credit evaluation [3]. - The measures will initially be trialed in certain regions, aiming to create a regulatory system characterized by institutional responsibility, regulatory constraints, credit management, and legal penalties [3].
首次!国产高端仪器品牌反超全球老牌,占比超80%
仪器信息网· 2025-07-16 07:48
Core Insights - The SIM super-resolution microscopy market in 2024 shows that domestic brands account for over 80% of the market share, with higher education institutions being the primary buyers, and Zhejiang, Guangdong, Sichuan, and Beijing identified as key procurement regions [1][2][16]. Market Overview - SIM (Structured Illumination Microscopy) is a significant super-resolution technology that overcomes the diffraction limit of traditional optical microscopes, providing high resolution, low light toxicity, and fast imaging capabilities [2]. - The analysis covers 30 winning bids with a total value of 142 million yuan, focusing on public tender data from January 1, 2024, to December 31, 2024 [2][3]. Buyer Distribution - The distribution of buyers by province indicates that Zhejiang leads with a 17% share, followed by Guangdong at 13%, and both Sichuan and Beijing at 10%. Other provinces like Hubei, Shanxi, Henan, and Shanghai each account for 7% [6][10]. Buyer Type Distribution - The buyer type distribution reveals that higher education institutions dominate the market with a 50% share, followed by research institutes at 27% and the healthcare system at 23%, illustrating a clear tiered market structure [10][11]. Brand Distribution - Domestic brands hold a commanding 83% share of the market, significantly outpacing imported brands, which only account for 7% [14][16]. - Leading brands in the market include Naxite Technology and Guangzhou Super Vision, followed by Aier Technology and Zeiss [16]. Conclusion - The 2024 SIM super-resolution microscopy market is characterized by strong demand from higher education institutions, a significant presence of domestic brands, and key procurement regions that reflect robust economic and research capabilities [16].
单台预算203万!离心机公开招标汇总(第28周)
仪器信息网· 2025-07-16 07:48
Core Insights - The demand for laboratory centrifuges in week 28 exceeded 98 units, with a total budget of over 4.8696 million yuan, indicating a strong market interest in this equipment [1][2]. Procurement Overview - The highest procurement budget was allocated by Chongqing Medical University Affiliated Children's Hospital, amounting to 2.5591 million yuan, with a bid deadline set for August 1, 2025 [2][3]. - Southwest Forestry University had the highest quantity of procurement, requesting 27 units, with a bid deadline also on July 31, 2025 [3][4]. Detailed Procurement Data - Chongqing Medical University Affiliated Children's Hospital is procuring various centrifuge models, including a super-speed centrifuge and a multifunctional refrigerated centrifuge, with budgets of 2,034,300 yuan and 524,800 yuan respectively [3][6]. - Southwest Forestry University is acquiring multiple types of centrifuges, including high-speed and low-speed models, with a total of 17 units specified in their procurement plan [4][6]. Additional Procurement Projects - Other institutions, such as the Chinese Academy of Traditional Chinese Medicine and Yunnan Forestry Vocational Technical College, are also participating in the procurement of centrifuges, with budgets ranging from 40,000 yuan to 700,000 yuan for various models [5][6]. - The procurement landscape includes a variety of centrifuge types, such as mini centrifuges, high-speed refrigerated centrifuges, and low-speed centrifuges, reflecting diverse needs across different educational and research institutions [5][7].
1.02亿元!海关系统设备更新采购大批仪器试剂耗材
仪器信息网· 2025-07-16 07:48
Core Viewpoint - The customs system has announced procurement intentions for 31 items of laboratory reagents and consumables, with a total budget of 102 million yuan, scheduled for procurement between June and October 2025 [1]. Group 1: Procurement Overview - The total budget for the procurement of laboratory reagents and consumables is 102 million yuan [1]. - The procurement includes high-performance liquid chromatography triple quadrupole mass spectrometers, high-efficiency liquid chromatographs, and other advanced laboratory instruments [1]. Group 2: Specific Procurement Projects - Qingdao Customs Technology Center plans to procure chemical reagents and consumables with a budget of 10 million yuan in August 2025 [3]. - Wuhan Customs Technology Center will procure various reagents and consumables for laboratory testing, with a budget of 2.68 million yuan in August 2026 [3]. - The Quanzhou Customs Comprehensive Technology Service Center intends to purchase one ultra-high-performance liquid chromatography triple quadrupole mass spectrometer for 2.6 million yuan and five high-efficiency liquid chromatographs for a total of 2.45 million yuan in June 2025 [3]. Group 3: Instrument Updates and Enhancements - The Weifang Customs Comprehensive Technology Service Center plans to update 22 laboratory instruments, including various chromatography and digestion instruments, in October 2025 [4]. - The Jiangmen Customs Technology Center will procure five laboratory instruments, including a liquid combustion test instrument and a high-pressure sterilizer, in July 2025 [4]. - The Jinan Customs Technology Center aims to enhance its laboratory capabilities by procuring 32 instruments to improve inspection efficiency and accuracy in July 2025 [4]. Group 4: Additional Procurement Initiatives - The Shenyang Customs Technology Center will procure various reagents and consumables, including chemical and biological reagents, with a budget of 1.85 million yuan in September 2025 [5]. - The Shanghai Customs International Travel Health Center plans to update outdated laboratory instruments to enhance testing capabilities with a budget of 3.05 million yuan in August 2025 [7].
用“一束光”闯出高端仪器“国产路”
仪器信息网· 2025-07-16 07:48
Core Viewpoint - The article highlights the successful development and commercialization of the ultra-high-resolution optical vector analysis technology by Nanjing University of Aeronautics and Astronautics (NUAA), which has achieved significant milestones in patent conversion and has been recognized as an excellent case for national patent application in 2025 [1][2]. Group 1: Technology Development - The research team, led by Professor Pan Shilong, identified a critical need for domestic high-end testing instruments due to reliance on foreign manufacturers, which posed challenges for scientific research and industrial development in China [3]. - The team developed the ultra-high-resolution optical vector analyzer using microwave photonics methods, integrating measurement functions for various optical components, which can be applied in multiple fields such as fiber optic communication and integrated photonics [5]. - The technology has achieved a wavelength resolution of 50 kHz (0.4 femtometers), a dynamic range improvement of 15 dB, and a phase accuracy enhancement of 2.5 times within a 40 GHz range, positioning China's optical vector analysis technology at the forefront globally [8]. Group 2: Commercialization and Market Impact - The transition from laboratory prototypes to commercial products faced challenges, including funding shortages and low market recognition, which the team overcame through strategic partnerships and product demonstrations [9][10]. - By 2018, the technology had successfully replaced imported high-end instruments, supporting over 100 types of high-end optical device development for major companies like Huawei and China Aerospace Science and Technology Corporation [10]. - The technology has been recognized as internationally pioneering, with 58 products achieving mass production and self-sufficiency, significantly reducing China's dependence on imported measurement equipment [10]. Group 3: Future Prospects - The demand for high-end optical devices is expected to grow with the advancement of emerging technologies such as 5G/6G communication and artificial intelligence, prompting the team to continue innovating and exploring new frontiers like quantum communication [10].
报名:第六届中药分析及质量控制网络会议
仪器信息网· 2025-07-16 07:48
Core Viewpoint - The article emphasizes the modernization and industrialization of traditional Chinese medicine (TCM), highlighting the importance of quality supervision, standard system improvement, and the integration of modern technology to enhance the industry's development [1]. Group 1: Conference Overview - The sixth "Traditional Chinese Medicine Analysis and Quality Control Network Conference" will take place on July 17-18, 2025, co-hosted by the Chinese Pharmaceutical Biotechnology Association and the Instrument Information Network [3]. - The conference aims to provide a platform for experts and manufacturers to exchange cutting-edge results in the field of TCM analysis and quality control [1]. Group 2: Conference Themes and Topics - On July 17, discussions will focus on "Frontier Technologies Empowering TCM Research and Quality Upgrade," featuring reports on "Frontier Analysis Technologies and Methods" and "Analysis of Active Ingredients and Mechanisms of Action" [2]. - On July 18, the theme will shift to "Analytical Detection Technologies Supporting Healthy Industry Development," covering "Quality Control and Standardization Practices" and "Risk Substance Analysis and Control" [2]. Group 3: Expert Participation - Notable experts from prestigious institutions such as Tsinghua University, Peking University, and Macau University will present their findings, ensuring a comprehensive exploration of TCM modernization and scientific development [2][3].
中嘉微视获近亿元A轮融资,国产量/检测设备双赛道突围!
仪器信息网· 2025-07-16 07:48
导读: 中嘉微视完成近亿元A轮融资,专注机器视觉与光学检测,打破国外技术垄断,布局半导体及显示领域,实现国产替代。 特别提示 微信机制调整,点击顶部"仪器信息网" → 右上方"…" → 设为 ★ 星标,否则很可能无法看到我们的推送。 仪器信息网讯:7月11日,中嘉微视顺利完成近亿元A轮融资。本轮融资由国泰君安创新投、国金鼎兴、天通股份等机 构共同投资,标志着资本市场对公司技术实力和发展前景的高度认可。 中嘉微视自创立起即聚焦"显示前道+晶圆前道"双赛道,致力于高端量/检测设备的自主研发与产业化,成为国产高端 量/检测设备的核心力量。公司自主研发的代表性产品——应用于显示面板关键制程(如EVEN、BP道工艺)的检测设 备,属于全国首台套,获权威机构认定为国际先进水平,被视为打破国外技术封锁的重要里程碑。 目前,中嘉微视与国际知名厂商京东方、天马、华星光电、维信诺等建立了长期稳定的合作关系。中嘉微视作为目前国 内唯一在六大面板厂商(京东方、TCL、天马、维信诺、HKC、EDO)的OLED前道均获得批量订单的企业,已实现 累计销售额 超5亿元人民币 。 值 得 一 提 的 是 , 2025 年 6 月 , 中 嘉 ...
预算1.08亿元!华南理工大学采购大批仪器
仪器信息网· 2025-07-16 07:48
Core Viewpoint - South China University of Technology has announced multiple government procurement intentions for laboratory instruments, with a total budget of 108 million yuan, focusing on various advanced equipment for paper and fiber research [1][2]. Procurement Overview - The procurement includes 10 items of laboratory equipment, with a total budget of 108 million yuan, covering systems such as pulp and paper process fluid visualization experimental systems, pilot-scale curing platforms for paper-based materials, high-concentration pulp systems, ultra-low quantitative paper preparation systems, and printed circuit board pilot preparation systems [2][4]. Equipment Specifications - The equipment specifications include: - **Pulping and Paper Equipment**: - Visualization experimental system with parameters such as fiber length (2mm-20mm) and concentration (0.01wt%-0.50wt%) [3]. - Special fiber grading system with a flow rate of ≥1500L/min and various screening systems [5]. - **High-Concentration Pulp System**: - Parameters include inlet concentration (3-5%) and outlet concentration (25-30%) [6]. - **Ultra-Low Quantitative Paper Preparation System**: - Features a forming concentration of 0.001-0.05wt% and a speed of 5-30m/min [6]. - **Printed Circuit Board Preparation System**: - Designed for a working speed of 3-20 m/min and a forming concentration of 0.8wt%-2wt% [6]. Additional Equipment - Other notable equipment includes: - **4D Facial Expression Capture System**: - Comprising 24 cameras with a resolution of 4096*3000 and a frame rate of 20/30/60 fps [8]. - **Wireless Portable Near-Infrared Brain Function Imaging Device**: - Features 16 light sources and detectors, with a sampling rate of 70-240Hz [8]. - **Field Emission Scanning Electron Microscope**: - Capable of achieving a secondary electron resolution of ≤0.7nm at 15kV [8]. - **Advanced Pulp Testing Equipment**: - Includes modules for rapid automatic water filtration performance testing and fiber wall thickness testing [9].