PQ/Porapak Q填充柱 医疗保健产品灭菌环氧乙烷残留测定

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医疗保健产品灭菌环氧乙烷残留测定
医疗保健产品灭菌环氧乙烷残留测定 详细信息：

名称：填充柱
固定相：高分子小球
粒度：60-80目
规格：1-2m*内径2-3mm
型号：Porapak Qs
应用：
GB 18281.2-2000 医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌用生物指示物

浩瀚色谱（山东）应用技术开发有限公司建立气相色谱法检测口罩、防护服等医疗防护用品中环氧乙烷的残留量,为生产厂家改进灭菌工艺提供数据支持。气相色谱法采用顶空进样、FID检测器,环氧乙烷的质量浓度在0.5～8 μg/mL范围内与色谱峰面积线性关系良好,检出限为0.10 μg/g,定量限为0.35 μg/g。环氧乙烷测定结果的相对标准偏差为1.73%（n=6）,平均加标回收率为94.3%～99.3%。该方法操作简便,精密度、准确度较高,适用于医疗防护用品中环氧乙烷的测定。


医疗保健产品灭菌环氧乙烷残留测定  测试谱图：



Determination of Sterilized Ethylene Oxide Residues in Healthcare Products
Sterilization Ethylene Oxide Residue Determination of Healthcare Products Details:

Name: Packed Column
Stationary phase: polymer beads
Granularity: 60-80 mesh
Specifications: 1-2m* inner diameter 2-3mm
Model: Porapak Qs
application:
GB 18281.2-2000 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for sterilization of ethylene oxide

GB 18281.2-2015 Sterilization of Healthcare Products - Ethylene Oxide - Part 1: Requirements for the Development, Validation and Routine Control of the Sterilization Process for Medical Devices
GB 18281.2-2015 Sterilization of Health Care Products   Biological Indicators   Part 2: Biological Indicators for Ethylene Oxide Sterilization

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a gas chromatography method to detect the residual amount of ethylene oxide in medical protective equipment such as masks and protective clothing, and provide data support for manufacturers to improve the sterilization process. Gas chromatography adopts headspace injection and FID detector. The mass concentration of ethylene oxide has a good linear relationship with the chromatographic peak area in the range of 0.5-8 μg/mL. The detection limit is 0.10 μg/g, and the quantification limit is 0.35. μg/g. The relative standard deviation of the determination results of ethylene oxide was 1.73% (n=6), and the average recovery was 94.3%-99.3%. The method is easy to operate, has high precision and accuracy, and is suitable for the determination of ethylene oxide in medical protective equipment.


Determination of Sterilized Ethylene Oxide Residues in Healthcare Products Test Spectrum:


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