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環氧乙烷殘留分析儀

環氧乙烷殘留分析儀

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發布日期:2020/03/02 10:15:25
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詳細介紹

一、概述:

2020年春節前夕新型冠狀病毒引發的肺炎疫情令國人憂心,面對疫情佩戴口罩無疑是隔離病毒的有效防范措施之一,隨著疫情的發展,口罩成了2020年春節期間,被瘋搶的“年貨”,口罩難買,全國缺貨,但更可怕的是,你花高價買到的口罩,還可能是假的,因此醫用口罩的生產過程極為嚴格,尤其滅菌至關重要一環。

二、環氧乙烷(EO)滅菌劑簡介及檢測概括

環氧乙烷(EthyleneOxide,簡稱EO),又名氧化乙烯,具有頑強的擴散和穿透能力,對細菌芽孢、真菌和病毒等各種微生物均有滅殺作用,屬于廣譜滅菌劑。環氧乙烷蒸汽壓力大、對包裝和滅菌物體穿透性強,且具有很強的氧化性能,故廣泛用于醫療設備的滅菌和消毒過程,但環氧乙烷也是一種有毒的致癌物質,一次性無菌醫療器械產品直接與人體組織、血液相接觸,其安全性、有效性直接涉及到患者的生命健康和安全,因此國家標準要求對生產過程中環氧乙烷(EO滅菌劑殘留量進行檢測。

三、國家標準

目前環氧乙烷測定的國家標準有:《GB/T16886.7-2015醫療器械生物學評價第7部分環氧乙烷滅菌殘留量》(等效于ISO10993-7:2008)、《GB/T14233.1-2008醫用輸液、輸血、注射器具檢驗方法第1部分:化學分析方法》等;此外,如河北省地方標準《DB13/T1081.22-2009食品用包裝材料及制品塑料第22部分:環氧乙烷和環氧丙烷含量的測定》也提供了測定環氧乙烷和環氧丙烷含量的方法,該方法中環氧乙烷和環氧丙烷單體的測定低限均為0.2mg/kg。

四、環氧乙烷殘留量檢測—氣相色譜法

頂空氣相色譜法測定環氧乙烷殘留量,檢測效率快,分析周期短,操作簡單,準確度高,操作簡單是醫療器材生產廠及醫院的實用檢測方案。該方法符合國標,GB/T14233.1-2008醫用輸液、輸血、注射器具檢驗方法第1部分:化學分析方法GB/T16886.7-2015醫療器械生物學評價第7部分:環氧乙烷滅菌殘留量(2)

五、標準品制作方法

醫療器械滅菌檢測環氧乙烷殘留量;頂空氣相法專用標準品;應國家標準要求;需要6個梯度濃度(1、2、3、5、8、10ppm);可以直接選取10mg/L的即10ppm的濃度作為母液,進行梯度稀釋,稀釋用純水(純水機二級水、屈臣氏蒸餾水等)

六、色譜與頂空操作條件

醫療器械中環氧乙烷(EO)殘留

儀器型號:GC3900plus  瑞能儀器生產

色譜柱:EO殘留分析專用色譜柱

使用溫度:200                   
標準物濃度:0.107mg/ml   

樣品溫度:110
器:FID     

定量方法:外標法
    溫:120   

進樣I180
加壓壓力:0.16MPa 

載氣壓力:0.05Mpa
樣品瓶:  80
閥溫    100
管線 80

七、現場譜圖及校正曲線表

 

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