Stainless work不锈钢
Furniture, racks, trolleys, pallets, platforms, and one-off fabrication sized to the AGV interface.家具、货架、推车、托盘、平台,以及按 AGV 接口做的单件加工。
Case studies案例
Clean movement, AGV-ready steel, a cleaning robot, and wireless monitoring. Figures are stated as specified. They are not averaged. 洁净转运、适配 AGV 的钢件、清洁机器人,以及无线监测。数字按规格原文列出,不做平均。
01 · Production material01 · 生产物料
Proposed handoff only. It needs an approved risk assessment, qualification, validation, change control, and QA approval before anyone runs it. 仅为拟议交接。运行之前须完成风险评估、确认、验证、变更控制,并获得 QA 批准。
A person opens the handoff.由人员开始交接。
Loading configuration and worst-case exposure have to be defined.装载方式和最差照射条件必须写明。
Route, interface, and transfer status are qualified. Manual transfer is the alternate path.路线、接口和转运状态须确认。替代路径是人工转运。
First treatment inside the automated barrier.自动化屏障内的第一道处理。
Non-contact sanitization from NC into CNC. Microbial reduction has to be validated. A failed cycle goes to deviation and disposition.从 NC 进入 CNC 的非接触消毒。微生物降低水平必须验证。失败周期按偏差和处置执行。
Handoff onto the cleanroom vehicle.接驳到洁净区车辆。
The load is inside CNC, still short of Zone C/D.物料已在 CNC,尚未进入 C/D 区。
Approved manual step at the C/D material airlock. Disinfectant, concentration, contact time, and the operator’s qualification are controlled.在 C/D 物料气闸做经批准的人工步骤。消毒剂、浓度、接触时间和人员资质受控。
Entry only after that second barrier.通过第二道屏障之后才进入。
Release criteria, monitoring, maintenance, and requalification stay in force after the first cycle.首次周期之后,放行标准、监测、维护和再确认仍然有效。
02 · Build and automate02 · 建造与自动化
Furniture, racks, trolleys, pallets, platforms, and one-off fabrication sized to the AGV interface.家具、货架、推车、托盘、平台,以及按 AGV 接口做的单件加工。
Barcode or QR into ERP or SAP, so issue and receipt stay traceable when the carrier moves.条码或二维码进入 ERP 或 SAP,载具移动时收发仍可追溯。
Physical movement and the inventory movement are specified together, not bolted on after installation.实体物流和库存流动一起规定,而不是安装后再外挂。
03 · Controlled environment03 · 受控环境
Legatus Formworks is the Singapore authorised partner. The drawings show the machine as specified. Legatus Formworks 是新加坡授权合作方。图纸按规格给出这台设备。
04 · IoT EVMS04 · 物联网 EVMS
End node, gateway, server, user. LoRaWAN on the room side. TCP/IP with TLS 1.2 after the gateway. The system is specified for 21 CFR 11. 终端节点、网关、服务器、用户。房间侧是 LoRaWAN。网关之后是带 TLS 1.2 的 TCP/IP。系统规格包含 21 CFR 11。
Temperature and humidity in the warehouse or cleanroom. Room pressure, oxygen, carbon dioxide, and particles are in the wider set, plus chamber and utility points.仓库或洁净室的温度与湿度。更大的范围还包括房间压差、氧气、二氧化碳和粒子,以及箱体与公用工程点。
LoRa from the node. LoRaWAN off the gateway.节点侧 LoRa。网关向外是 LoRaWAN。
Cloud or on-premise. Secure payload over TCP/IP, TLS 1.2.云或本地。安全载荷走 TCP/IP,TLS 1.2。
Central validation and routine monitoring. Scale the sensor count up for a study, then down for daily use.中央确效与例行监测。研究时增加传感器,日常使用时减少。
Site 1现场 1
A 7-day mapping ran on to 28 days because the data held. The client used it for engineering troubleshooting, pre-validation, validation, and a daily report. 计划 7 天的测绘因数据良好延至 28 天。客户将其用于工程排障、预确认、确认和日报。
Site 2 · GDP warehouse现场 2 · GDP 仓储
Validation manpower reported at half. Monitoring stayed live during the mapping, then the install scaled down to routine monitoring. 确效人力报为减半。测绘期间监测保持实时,随后缩编为例行监测。
50 Tuas Avenue 11, #02-17, Singapore 639107. 新加坡大士 11 道 50 号 #02-17,邮编 639107。
bioworks@legatus.com.sg