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Cleanroom Technology 洁净室与高科技制造·· 5 天前次级推荐AI 评分61

「英中对照」UV Medico在欧洲某制药设施分级洁净室入口安装UV222 Wall型操作人员去污系统

UV Medico installs operator decontamination system at European pharma facility

AI 导读

丹麦过滤UVC系统制造商UV Medico已在欧洲某制药设施的分级洁净室入口安装UV222 Wall型操作人员去污系统。该系统为壁挂式设计,采用过滤222nm远UVC技术,人员更衣后进入洁净室前增设20秒无接触去污周期,无需大幅改动现有洁净室布局,适配空间有限的现有及棕地洁净室。其运行符合国内外眼与皮肤暴露限值,属附加污染控制措施,不替代现有更衣及洁净室流程。

推荐理由

材料披露了远紫外人员去污技术在存量制药洁净室的落地案例,所述污染控制效果、暴露限值合规性均为厂商主张,项目具体业主、安装时间及实测运行数据未披露,需结合现场情况核验。

正文 · 中英逐段对照

UV Medico, a Danish manufacturer of filtered UVC systems, has installed a UV222 Wall at a pharmaceutical facility in Europe. UV Medico 是丹麦的过滤式 UVC 系统制造商,已在欧洲一家制药工厂安装了一台 UV222 Wall。 

The newly installed UV222 Wall from UV Medico is designed to provide an additional decontamination step at this point in the personnel flow, using filtered 222 nm Far-UVC.这台新安装的 UV Medico UV222 Wall 采用经过滤的 222 nm 远 UVC,旨在人员流线的这一环节增加一道去污步骤。

The UV222 Walls make the transition between gowning and entry into a classified cleanroom an important point for contamination control.UV222 Wall 使更衣与进入分级洁净室之间的过渡成为污染控制的重要节点。

The system is mounted flat against an existing wall at the cleanroom entrance, allowing personnel to stand in front of the unit before crossing into the classified area.该系统平贴安装在洁净室入口的现有墙面上,人员可在进入分级区域前站在设备前方。

According to UV Medico, the installation adds a 20-second cycle to the existing entry routine without requiring major changes to the cleanroom layout.据 UV Medico 介绍,该装置在现有进入流程中增加了一个 20 秒循环,无需对洁净室布局进行重大改动。

Wall-mounted approach壁挂式方案

The UV222 Wall is an adaptation of UV Medico's UV222 Booth, developed for facilities where available floor space is limited.UV222 Wall 是 UV Medico UV222 Booth 的改型,专为可用地面空间有限的设施开发。

Rather than enclosing the operator, the wall-mounted system presents a single emitter plane against the existing wall. Personnel stand on designated floor markings and activate the system without touching it.壁挂式系统不会将操作人员围住,而是在现有墙面上提供单一发射平面。人员站在指定的地面标识上,无需触碰即可启动系统。

This format is intended particularly for existing or brownfield cleanroom facilities, where introducing additional contamination-control equipment can be difficult because the layout and personnel flows are already established.这种形式特别适用于现有或棕地洁净室设施;由于布局和人员流线已经确定,在这些设施中增设污染控制设备可能较为困难。

By using the wall rather than a freestanding enclosure, the system can be positioned within circulation space while leaving existing personnel routes and sightlines largely unchanged.通过利用墙面而非独立围闭间,该系统可布置在通行空间内,同时基本保持既有人员路线和视线不变。

The unit is specified according to the entry point it serves, with the installation designed around the requirements of that particular location.该设备根据其所服务的入口点确定规格,安装则围绕该特定位置的要求进行设计。

Does the UV222 Wall have any health and safety impacts?UV222 Wall 是否会对健康与安全产生任何影响?

There have been concerns raised from individuals involved in the pharmaceutical industry regarding how the UV222 Wall might impact operators' eyes.制药行业相关人士对 UV222 Wall 可能如何影响操作人员的眼睛提出了担忧。

“Operators using the Wall wear protective glasses as part of their cleanroom gowning. Far-UVC is blocked by those glasses. In addition, each decon cycle stays within national and international exposure limits for eyes and skin,” wrote a representative from UV Medico on LinkedIn. “使用 UV222 Wall 的操作人员佩戴护目镜,作为其洁净室更衣的一部分。远 UVC 会被这些眼镜阻挡。此外,每次去污循环都符合国家和国际关于眼睛和皮肤的暴露限值,”UV Medico 的一名代表在 LinkedIn 上写道。 

222 nm is largely absorbed in the outer, non-living layers of the skin and eyes, which is why the UV222 Wall can treat gowned operators directly, within international exposure limits.222 nm 光线大部分被皮肤和眼睛的外层无生命层吸收,因此 UV222 Wall 可在国际暴露限值内直接对更衣后的操作人员进行处理。

The UV Medico representative said that the company works based on the scientific evidence and exposure limits currently available.该 UV Medico 代表表示,公司基于目前可用的科学证据和暴露限值开展工作。

“Our systems are designed to operate within those limits, and if the science or regulations change, we will adapt accordingly.”“我们的系统在设计上就是在这些限值内运行的;如果科学或法规发生变化,我们也会相应调整。”

20-second decontamination cycle20 秒去污循环

Once fully gowned, an operator steps onto the marked position in front of the UV222 Wall and hovers a hand over the start sensor for two seconds.完成全部更衣后,操作人员走到 UV222 Wall 前方的标识位置,将手悬停在启动传感器上方两秒钟。

The system then runs its 20-second cycle, applying filtered 222 nm Far-UVC to the operator before they proceed into the cleanroom.随后系统运行其 20 秒循环,在操作人员进入洁净室之前,对其施加经过滤的 222 nm 远 UVC。

Activation is touch-free, with the same sensor used to stop the cycle if required.启动为非接触式;如有需要,也可使用同一传感器停止循环。

An emergency stop is also provided for servicing and cleaning.还设有用于维护和清洁的紧急停止装置。

The UV222 Wall isn't an air shower. It acts on surfaces.UV222 Wall 不是风淋室。它作用于表面。

"Even after correct gowning, microorganisms can be on the gown surface, and the Wall adds a 20-second step to inactivate them before the operator enters the classified area. It's an additional layer, not a replacement,” wrote a representative from UV Medico on Linked In. “即使正确更衣后,微生物仍可能存在于洁净服表面,而 UV222 Wall 增加了一个 20 秒步骤,在操作人员进入分级区域前将其灭活。这是额外的一层,而非替代措施,”UV Medico 的一名代表在 Linked In 上写道。 

An integrated status light indicates the operating state of the system, including ready, starting, in use, complete and fault conditions. 集成状态灯可指示系统的运行状态,包括就绪、启动中、使用中、完成和故障状况。 

The status indication combines colour and audio signals, allowing operators to check the system without using a touchscreen, display or handset.状态指示结合了颜色与声音信号,使操作人员无需使用触摸屏、显示器或手持设备即可检查系统。

The absence of physical controls and adhesive labels is also intended to support use in classified environments, where surfaces need to remain smooth, cleanable and resistant to shedding.无物理控件和粘性标签的设计也旨在支持在受控环境中使用,这类环境中的表面需要保持光滑、可清洁且抗脱落。

Far-UVC at the cleanroom entry point洁净室入口处的远紫外线C

The UV222 Wall uses filtered 222 nm Far-UVC, a wavelength technology that UV Medico says is designed for use in occupied spaces when installed and commissioned in accordance with applicable exposure limits.UV222 Wall 采用经过滤的222 nm远紫外线C;UV Medico表示,在按照适用暴露限值进行安装和调试的情况下,这种波长技术设计用于有人在场的空间。

The approach provides a chemical-free decontamination step, with no chemical residues introduced into the personnel flow.该方法提供了无化学污染物的去污步骤,不会在人员流动路径中引入化学残留。

For cleanroom operators, the system is therefore positioned as an additional contamination-control measure between gowning and entry into the classified environment, rather than as a replacement for existing gowning or cleanroom procedures.因此,对于洁净室运营商而言,该系统被定位为更衣与进入受控环境之间的一项附加污染控制措施,而非替代现有更衣或洁净室规程。

“Operators might keep generating contamination once inside, where gowning, operator behaviour and Air Changes per Hour (ACH) remain the main controls. But, the data from our multiple customers says otherwise, as we have significantly reduced their environmental deviations,” wrote a representative from UVMedico on LinkedIn. “操作人员进入后可能会持续产生污染,在该环境中,更衣、操作人员行为和每小时换气次数(ACH)仍是主要控制手段。但我们多个客户的数据表明并非如此,因为我们已显著减少了他们的环境偏差,”UVMedico的一名代表在LinkedIn上写道。 

The installation at the pharmaceutical cleanroom demonstrates how Far-UVC technology can be incorporated into an existing personnel route without requiring a substantial change to the surrounding cleanroom infrastructure.该制药洁净室的安装展示了如何将远紫外线C技术整合到现有人员路线中,而无需对周边洁净室基础设施进行重大改造。

来源:Cleanroom Technology 洁净室与高科技制造 · cleanroomtechnology.com