2026年7月5日，FDA公布了对VA San Diego Healthcare Systems无菌药品生产设施的483报告（FEI编号：2071629），该报告涉及的无菌保障缺陷与以往的缺陷项有所不同之处在于对无菌保障关注点从墙壁、地板和工作台面，转移到了高频接触的电子设备（键盘、鼠标、扫码枪等）管理，值得大家一起来看看。
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无菌保障失效涉及电子设备相关的缺陷项 缺陷 1：动态烟雾试验未覆盖真实电子设备与操作OBSERVATION 1 (A & B)原文："Your smoke study... did not introduce smoke to visualize airflow at the equipment and workflow management system containing the scale and camera for production operations." "...did not include... handheld scanner with base, and printing of labels."翻译：你们的烟雾试验……没有引入烟雾来使包含秤和相机的生产操作工作流管理系统处的空气流向可视化。此外，（烟雾试验）未包括手持扫描枪及其底座，以及标签打印机。 缺陷 2：触碰外设电子设备后后未消毒即进入 ISO 5 核心区OBSERVATION 6原文："On 04/28/2026... an operator failed to sanitize or change their gloved hands... after touching the computer keyboard and mouse within the ISO 7 buffer room prior to going back into the ISO 5 critical area..."翻译：在2026年4月28日生产期间……一名操作员在ISO 7缓冲间触摸计算机键盘和鼠标后，在返回ISO 5关键区继续无菌加工前，未能使用消毒剂消毒或更换戴手套的手。 缺陷 3：第三方人员与 SOP 忽略电子设备清洁OBSERVATION 6原文："Your SOP only specifies (b)(4) surfaces. We did not observe your third party cleaners cleaning and sanitizing your keyboards, mouse, and handheld scanner."翻译：你们的SOP仅规定了特定表面的清洁。我们未观察到你们的第三方清洁人员对键盘、鼠标和手持扫描枪进行清洁和消毒。 缺陷4： 可穿戴通信设备进入 ISO 5 环境但控制不足OBSERVATION 4 (C)原文："The wearable, (b)(4) communication deviceThe wearable, (b)(4) communication device is inconsistently worn by operators entering the ISO 5 environment during aseptic processing of sterile drug products, with some operators wearing the device over their gown and others wearing it under their gown,... result[s] in direct or potential exposure of the device to the ISO 5 environment... No sporicidal agent is used to clean these devices, and no environmental monitoring is performed to assess the contamination risk they may introduce."翻译：可穿戴式通信设备，佩戴的可穿戴式通信设备（具体型号被 FDA 隐去）佩戴方式不一致。有些人员把设备戴在防护服外面；有些人员把设备戴在防护服里面。……导致设备直接或潜在暴露于ISO 5环境中。未使用杀孢子剂清洁这些设备，也未进行环境监测以评估它们可能引入的污染风险。注意：FDA 认为这种穿戴不一致本身就是风险，企业没有建立明确的设备进入关键区域的控制策略。 缺陷5： 固定电子设备未记录清洁OBSERVATION 8 (C)原文："...cameras, andWiFi device on the ceilings of the buffer rooms (room (b)(4)) were not documented as cleaned."翻译：……缓冲间（房间 (b)(4)）天花板上的摄像头和WiFi设备没有被记录为已清洁。 缺陷6： 电子工作流设备批次间未消毒OBSERVATION 8 (E)原文："...the electronic workflow equipment located within each non-hazardous ISO 5 LAFH (room (b)(4)) was observed to not be wiped down with an appropriate disinfectant... between individual batches."翻译：……放置在各非危险品ISO 5层流罩（LAFH）内的电子工作流设备，在不同批次之间没有使用合适的消毒剂进行擦拭。 缺陷7：洁净区内出现未经允许的电子设备OBSERVATION 8 (D)原文："On 04/28/2026, Bluetooth speakers were observed on the workbench of the ISO 7 buffer room, across from the ISO 5 laminar airflow hood (LAFH)..."翻译：在2026年4月28日，在ISO 7缓冲间的工作台上发现了蓝牙音箱，该位置正对着用于无菌生产的ISO 5层流罩（LAFH）。
