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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p data-mpa-powered-by="gulangu"><span>来源：</span><span>制药项目管理联盟PPMP同学会</span></p><p><br /></p><p mpa-paragraph-type="body" data-mpa-powered-by="gulangu"><span>前言：数据显示，2019年我国口罩行业整体产值达到102亿元，同比增长12.6%，其中医用口罩产值55亿元，同比增长15.5%。</span></p><p mpa-paragraph-type="body" data-mpa-powered-by="gulangu"><br /></p><p mpa-paragraph-type="body"><span>受新型冠状病毒肺炎疫情影响，目前全国市场上一“罩”难求，极大地影响着群众健康防护与企业复工安全。为了应对此次危机，缓解医用口罩的短缺，各地纷纷上马口罩项目。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>笔者结合近期从事口罩生产设计工作经历，将口罩生产线建设相关问题做以汇总，供业内人士参考，不足之处请指出。</span></p><p mpa-paragraph-type="body"><br mpa-from-tpl="t" /></p><section data-mpa-template="t" mpa-from-tpl="t"><section powered-by="gulangu" mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><p><strong mpa-from-tpl="t" mpa-is-content="t">一、口罩分类</strong></p></section><section mpa-from-tpl="t"><br /></section></section></section></section></section><p><br mpa-from-tpl="t" /></p><p mpa-paragraph-type="body"><span>从生产技术角度，目前市面上的口罩基本分为三类：日常防护型口罩、专业呼吸防护口罩以及医用口罩。</span><br /></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>第一种，日常防护型口罩，主要指日常生活中，空气污染环境下滤除颗粒物所佩戴的防护型口罩，执GB32610-2016《日常防护型口罩技术规范》，要求佩戴各防护等级口罩后使吸入的PM2.5浓度降低至75微克每立方米以下，即过滤后吸入体内的空气质量达到良及以上水平，才是合格的日常用防护口罩。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>第二种，专业防护口罩，执行GB2626—2006《呼吸防护用品——自吸过滤式防颗粒物呼吸器》， 此标准主要针对安全环保，防护对象从粉尘到各类颗粒物，包括粉尘、烟、雾和微生物。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>第三种，医用防护口罩，又分医用防护口罩、医用外科口罩和一次性使用医用口罩。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>（1）医用防护口罩适用于医务人员和相关工作人员对经空气传播的呼吸道传染病的防护。</span></p><p mpa-paragraph-type="body"><span>（2）医用外科口罩适用于医务人员或相关人员的基本防护，以及在有创操作过程中阻止体液和喷溅物传播的防护。</span></p><p mpa-paragraph-type="body"><span>（3）一次性使用医用口罩适用于佩戴者在不存在体液和喷溅风险的普通医疗环境下的卫生护理。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>三种医用口罩执行标准如下：</span></p><p mpa-paragraph-type="body"><span>（1）医用防护口罩：应符合GB 19083-2010《医用防护口罩技术要求》；</span></p><p mpa-paragraph-type="body"><span>（2）医用外科口罩：应符合YY 0469-2011《医用外科口罩》；</span></p><p mpa-paragraph-type="body"><span>（3）一次性使用医用口罩：应符合YY/T 0969-2013《一次性使用医用口罩》要求。</span></p><p mpa-paragraph-type="body"><br mpa-from-tpl="t" /></p><section data-mpa-template="t" mpa-from-tpl="t"><section powered-by="gulangu" mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><p><span><strong mpa-from-tpl="t" mpa-is-content="t">二、医药口罩管理办法及生产技术要求</strong><strong mpa-from-tpl="t" mpa-is-content="t"></strong></span></p></section><section mpa-from-tpl="t"><br /></section></section></section></section></section><p><br mpa-from-tpl="t" /></p><p mpa-paragraph-type="body"><span>2019年01月15日的“国家药监局持续推进医疗器械注册技术审查指导原则制修订工作 ”中指导原则附录第47条为“医用口罩产品注册技术审查指导原则”。该指导原则适用于医用防护口罩、医用外科口罩和医用普通口罩（一次性使用医用口罩）。经查，医药口罩归属于《医疗器械分类目录》中管理类别为Ⅱ类，6864（医用卫生材料及敷料类），因此必须取得药品监督管理局颁发的注册证方可销售，监管比较严格。</span><br /></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><strong><span>（一） 医用口罩生产原料及分类</span></strong></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>常见的医用口罩主要由三层无纺布组成，内层是普通无纺布，外层是做了防水处理的无纺布，主要用于隔绝患者喷出的液体，中间一层是主体过滤材料，常用聚丙烯熔喷布材料。口罩生产用到的其他材料还包括，金属（用于鼻夹）、弹性材料（用于口罩带）等。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>医用口罩按照面罩形状可以分为平面形、鸭嘴形、拱形或折叠式等。按照佩戴方式可以分为耳挂式、绑带式或头带式。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><strong><span>（二） 医用口罩的检测要求</span></strong><span></span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>（1）医用口罩产品的检测包括出厂检验和型式检验。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>（2）出厂检验项目至少应有以下项目：外观、结构与尺寸、鼻夹、口罩带、微生物指标、环氧乙烷残留量（若采用环氧乙烷灭菌）的要求。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>（3）型式检验应为产品标准的全性能检验。</span></p><p mpa-paragraph-type="body"><span>以下部分（第三部分、第四部分）仅对医用防护口罩相关内容(执行GB 19083-2010《医用防护口罩技术要求》)作一阐述。</span></p><p mpa-paragraph-type="body"><br mpa-from-tpl="t" /></p><section data-mpa-template="t" mpa-from-tpl="t"><section powered-by="gulangu" mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><p><span><strong mpa-from-tpl="t" mpa-is-content="t">三、医用防护口罩生产工艺流程</strong><strong mpa-from-tpl="t" mpa-is-content="t"></strong></span></p></section><section mpa-from-tpl="t"><br /></section></section></section></section></section><p><br mpa-from-tpl="t" /></p><p mpa-paragraph-type="body"><span>口罩成型→压合→切边→呼吸阀焊接→耳带点焊→鼻梁条线贴合→呼吸阀冲孔→包装→灭菌→解析（EO灭菌）→成品</span></p><p mpa-paragraph-type="body"><br /></p><p mpa-paragraph-type="body"><span>全自动化机器相对来说省时高效，原材料挂于料架上，机台自动送料，由1台本体机拖2到3台耳带机进行自动生产。</span></p><p mpa-paragraph-type="body"><br /></p><section data-mpa-template="t" mpa-from-tpl="t"><section powered-by="gulangu" mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><section mpa-from-tpl="t"><p><span><strong mpa-from-tpl="t" mpa-is-content="t">四、医用防护口罩生产环境与主要生产设备</strong><strong mpa-from-tpl="t" mpa-is-content="t"></strong></span></p></section><section mpa-from-tpl="t"><br /></section></section></section></section></section><p><br mpa-from-tpl="t" /></p><p mpa-paragraph-type="body"><span><strong>（一）医药防护口罩生产环境</strong></span><br /></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>医用防护口罩执行GB 19083-2010《医用防护口罩技术要求》，包装上有灭菌或者无菌字样的口罩应无菌，按要求执行YY 0033-2000 《无菌医疗器具生产管理规范》。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="image"><p><img src="image/20201014/df883501627029d792ca0f984a823347_2.png" /></p><br /></p><p mpa-paragraph-type="body"><span>图1无菌医疗器具洁净室空气洁净度级别表（附录A）</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>附录B无菌医疗器具产品生产环境洁净度级别设置指南中明确：B4（B3规定以外的）无菌医疗器具或单包装出厂的零部件(不清洗件)的加工、末道精洗、组装、初包装及其封口均应在不低于300 000级洁净室(区)内进行。参照附录B，医药防护口罩生产一般在10万级洁净车间生产。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><strong><span>（二）医药防护口罩主要生产设备</span></strong></p><p mpa-paragraph-type="body"><br /></p><p mpa-paragraph-type="body"><strong><span>1.口罩生产设备</span></strong></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>医用防护口罩口罩的生产一般是全自动或者半自动设备。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>半自动的设备包括口罩成型机、口罩压合机、口罩切边机、呼吸阀冲孔机（若有呼吸阀）、鼻梁条线贴合机、耳带点焊机、呼吸阀焊接机（若有呼吸阀）；全自动设备包括全自动平面口罩机、全自动折叠口罩机等，费用较高但省时高效。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="image"><p><img src="image/20201014/8003fb01d60a34729011ee2359dc6c59_3.jpg" /></p><br /></p><p mpa-paragraph-type="body"><br /></p><p mpa-paragraph-type="body"><span>自动一拖二口罩生产设备</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><strong><span>2.灭菌设备</span></strong><span></span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>生产无菌医用口罩，涉及到灭菌工序。目前绝大部分企业选择的是环氧乙烷（EO）灭菌设备。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>环氧乙烷灭菌的口罩需要进行解析。因为环氧乙烷灭菌后，口罩上会有环氧乙烷残留，而环氧乙烷是一种有毒的致癌物质，长期吸入环氧乙烷，不但刺激呼吸道，还会有致癌可能性。长期少量接触，可见有神经衰弱综合征和植物神经功能紊乱。因此，经环氧乙烷灭菌的医用口罩，必须经过解析释放口罩上残留的环氧乙烷，经检测合格才能出厂上市。经过验证的环氧乙烷解析时间约为14天，可确保口罩中残留的环氧乙烷含量低于10ug/g的安全标准。 </span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>另外，环氧乙烷灭菌的口罩应选用透气的内包装材料。否则环氧乙烷难以穿透，难以达到灭菌效果。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>以上从口罩分类、医药口罩管理办法及生产技术要求、生产工艺流程、生产环境与主要生产设备四方面对医用防护口罩生产线建设相关问题做了汇总，以便于疫情期间同行交流参考。</span></p><p><br /></p><section data-role="outer" 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发表于 2020-10-14 12:54:33