04 · Clean material flow04 · 洁净物料流转

Warehouse, disinfection, cleanroom. 仓库、消毒、洁净室。

A complete movement and disinfection system. Not a machine standing on its own. 完整的转运与消毒系统，不是单独放着的一台设备。

Discuss this route讨论这条路径
Four stations. Move across the frame to take the load. Not a qualified cycle. 四个站点。在画面上移动即可带走物料。不是已确认的周期。

Stations站点

Four stops. Custom steel between them.四站。中间是定制钢件。

Pallets, trolleys, and carriers are part of the system. Disinfection is Spor-Klenz fumigation or xenon light. 托盘、推车与载具属于系统的一部分。消毒为 Spor-Klenz 雾化或氙光。

  1. 01

    Warehouse仓库

    Materials and consumables, staged.物料与耗材，暂存。

  2. 02

    AGV / AMR

    Automated transport off the warehouse floor.离开仓库地面的自动运输。

  3. 03

    Auto disinfection自动消毒

    Spor-Klenz or xenon.Spor-Klenz 或氙光。

  4. 04

    Cleanroom洁净室

    Controlled delivery.受控交付。

Proposed double disinfection拟议的双重消毒

Xenon first. A person second. 先氙光。再人工。

Proposed process only. Implementation requires an approved risk assessment, qualification, validation, change control, and QA approval. 本流程为拟议方案。实施前须完成风险评估、确认、验证、变更控制，并获得 QA 批准。

01 · NC → CNC

Automated xenon自动氙光

Non-contact surface treatment at the barrier. Microbial reduction has to be validated. A failed or interrupted cycle goes to deviation and material disposition. 屏障处的非接触表面处理。微生物降低水平必须验证。失败或中断的周期按偏差和物料处置执行。

02 · CNC → C/D

Manual disinfection人工消毒

Approved manual step at the C/D material airlock before Zone C/D. Disinfectant, concentration, contact time, and operator qualification are controlled. 进入 C/D 区之前，在 C/D 物料气闸做经批准的人工消毒。消毒剂、浓度、接触时间和人员资质受控。

Handoff order交接顺序

Person, pallet, AGV, barrier, release.人员、托盘、AGV、屏障、放行。

  1. Personnel人员
  2. Material on an SS pallet物料置于不锈钢托盘
  3. AGV transferAGV 转运
  4. Air purge, then automated xenon空气吹扫，然后自动氙光
  5. Cleanroom AGV handoff into CNC洁净区 AGV 接驳进入 CNC
  6. Second manual disinfection at the C/D MAL在 C/D 物料气闸做第二次人工消毒
  7. Release into Zone C/D放行进入 C/D 区
Layout drawing from the dirty side and warehouse cold room through MAL stations to the auto disinfection machine
Proposed layout: dirty side, warehouse cold room, MAL stations, and the auto disinfection machine. 拟议布局：污染侧、仓库冷库、MAL 工位，以及自动消毒机。

Controls that have to exist必须存在的控制

Qualified routes已确认的路线

AGV routes, interfaces, and transfer status are qualified. Loading configuration and worst-case exposure are defined.AGV 路线、接口和转运状态须确认。装载方式和最差照射条件要写明。

Release criteria放行标准

Routine monitoring, maintenance, requalification, and release criteria. Design, install, commission, then support.日常监测、维护、再确认和放行标准。设计、安装、调试，然后支持。

This stays proposed until QA signs it.在 QA 签字之前，它仍然是拟议方案。

Bring the room grades and the current transfer path. 带上房间级别和现在的转运路径。

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