GWF-DS1微粒分析仪审计追踪版

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GWF-DS1 微粒分析仪(审计追踪版)

性能特点:

n 满足《中国药典》、《美国药典》及输液器具等标准的要求,设有多种标准的专用检测程序,可直接检测注射液、无菌粉末及输液器具中不溶性微粒的大小及数量

n 高性能激光光源及光能量补偿电路,保证各种无色、有色澄明样品的测试精度

n 进样狭缝及管路采用进口316L及PTFE材料,可直接检测有机溶剂、油基质等弱酸碱腐蚀性特殊溶液

n 自动升降系统,适用于不规则包装检品的检测

n 高性能处理器,可自定义设置近万种粒径,精度0.1 µm,实现数据的高精度采集

n 全自动校准,提高校准效率,保证测试数据准确可靠

n 可按《中国药典》、《美国药典》、ISO21501等标准进行校准、检定,满足进出口检测要求

n 审计追踪功能保证电子数据的完整性,可随时调取设备的使用信息及检测数据

n 具有权限管理功能,保障数据安全,满足计算机化系统中对数据审计追踪的要求

n 内置数据库实现数据海量存储,具有数据统计分析功能

n 可视防尘门设计,防止环境对样品的污染

n 支持中英文切换,适用于不同语言环境

技术参数:

n 通道设置:64个(可自定义设置)

n 粒径范围:1~500 µm(分段选择)

n 计数范围:0~9999999粒

n 进样体积:0.2~1000 mL(精度0.1 mL)

n 进样体积精度:≤±0.5%

n 进样速度:5~80 mL/min

n 计数准确度:≤规定值±5%

n 通道分辨率:≥95%

n 相对标准偏差:≤1.5%(标准粒子≥1000粒/mL)

n 极限检测浓度:18000粒/mL

n 搅拌速度:0~1000转/min(磁力搅拌、分段可调)

n     源:AC 220 V ±10%;50 Hz;≤80 W

n 外形尺寸:317x320x459 mm

n 整机重量:16 kg

n 工作温度:10~40 ℃

n 工作湿度:5~80% RH

n 操作系统:Android

n 数据输出:内置微型针式打印机;RS232接口、USB存储接口

GWF-D1 Particle Counter

GWF-DS1 Particle Counter(Audit Trail Version)

Performance Features:

n Compliant with standards such as the Chinese Pharmacopoeia, United States Pharmacopoeia, and infusion apparatus requirements. Equipped with dedicated testing programs for various standards, capable of directly detecting the size and quantity of insoluble particles in injections, sterile powders, and infusion apparatus.

n High-performance laser light source and optical energy compensation circuit ensure testing accuracy for various colorless and colored clear samples.

n The entrance slit and tubing are constructed from imported 316L stainless steel and PTFE materials, allowing direct analysis of special solutions with weak acid/base corrosivity, such as organic solvents and oil-based matrices.

n Automatic lifting system accommodates irregularly packaged samples for versatile testing.

n High-performance processor supports customizable setting of nearly 10,000 particle size channels with 0.1 µm precision, enabling high-accuracy data acquisition.

n Fully automated calibration improves efficiency and guarantees reliable test results.

n Calibration and verification can be performed according to standards such as the Chinese Pharmacopoeia, United States Pharmacopoeia, and ISO21501, meeting import and export testing requirements.

n Audit trail function ensures electronic data integrity, allowing retrieval of device usage information and test data at any time.

n User permission management function ensures data security and meets computerized system requirements for data audit trails.

n Integrates a massive-capacity internal database for data storage, supporting advanced statistical analysis and retrieval.

n Transparent dust-proof door design minimizes environmental contamination during testing.

n Supports Chinese/English language switching for multilingual environments.

Technical Specifications:

n Channel Configuration: 64 channels (customizable)

n Particle Size Range: 1–500 µm (selectable in segments)

n Counting Range: 0–9,999,999 particles

n Sample Volume: 0.2–1,000 mL (0.1 mL precision)

n Volume Accuracy: ≤±0.5%

n Sampling Speed: 5–80 mL/min

n Counting Accuracy: ≤±5% of specified value

n Channel Resolution: ≥95%

n Relative Standard Deviation (RSD): ≤1.5% (for standard particles ≥1,000 particles/mL)

n Maximum Detectable Concentration: 18,000 particles/mL

n Stirring Speed: 0–1,000 rpm (magnetic stirring, adjustable in segments)

n Power Supply: AC 220 V ±10%, 50 Hz, ≤80 W

n Dimensions: 317×320×459 mm (W×D×H)

n Weight: 16 kg

n Operating Temperature: 10–40 °C

n Operating Humidity: 5–80% RH

n Operating System: Android

n Data Output: Built-in miniature pin printer; RS-232, USB storage interfaces


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