Equipment Master List¶
设备清单¶
Version: v1.0
Effective Date: TBD
1. Purpose / 目的¶
Provide a controlled, versioned list of all production, laboratory, quality and auxiliary equipment required for glucose test strip manufacturing.
2. Scope / 范围¶
Applies to L1/L2/L3 material preparation, enzyme preparation, Lines 1–3, QC laboratory, and packaging.
3. Equipment Categories / 类别¶
| Category | 设备名称 (CN) | Equipment Name (EN) | Model / Spec | Qty | Critical (Y/N) | Calibration Interval | Owner Dept |
|---|---|---|---|---|---|---|---|
| Cutting (Multimode) | 自动冲切机 | Automatic CCD Die Cutting Machine (Sheets/Roll) | CCD registration, multimode (sheets & roll), PET 400×420 fixture | 1 | Y | 12 months | Production |
| Screen Printing | 自动丝印机 | Automatic Screen Printer | Multi-color, CCD alignment | 1 | Y | 6 months | Production |
| Oven (Tunnel) | 隧道烘箱 | Tunnel Oven 7m Infrared + Heating | 130°C uniformity ±2°C, 7m length | 1 | Y | 6 months (temp mapping) | Production |
| Oven (Manual Vertical) | 手动立式烘箱 | Manual Vertical Drying Oven | 80–200°C range | 1 | Y | 6 months | Production |
| Oven (Enzyme Auto) | 自动酶液烘箱 | Automatic Enzyme Drying Oven | 50°C controlled | 1 | Y | 6 months | Production |
| Laminator | 复合热压机 | Precision Laminator + Hot Roll Line | 0.4 MPa @120–130°C | 1 | Y | 12 months | Production |
| Protective Film Applicator | 保护膜贴合机 | Protective Film Covering Unit | For L2 hot melt | 1 | N | 12 months | Production |
| Enzyme Dispenser | 酶液点胶机 | Automatic Enzyme Dispensing Machine | 3 µL ±2% | 1 | Y | 3 months (volume calibration) | Production |
| Vision Analyzer | 视觉检测仪 | NG Computer Vision Analyzer + QR Printer | QR + defect mapping | 1 | Y | Monthly (optics check) | QA |
| NG Puncher | 不良冲切机 | Defective Cell Puncher | Coordinates via DB | 1 | Y | 12 months | Production |
| Row Cutter | 行切机 | 30 mm Row Cutter & Splitter | Auto segregation | 1 | Y | 6 months | Production |
| Cell Slitter | 6mm单条分切机 | 6mm Cell Slitter | 4 stations (operator), manual mode for partial defect rows | 4 | Y | 6 months | Production |
| Vial Capper | 盖帽机 | Automatic Vial Capping Machine | Press-type (top press, not screw) | 1 | Y | 12 months | Packaging |
| Interlock Chamber | 传递窗 | Interlock Pass-Through Chamber | ISO-7 to Packing Room | 1 | N | 12 months | Production |
| Labeling Machine | 贴标机 | Automatic Labeling Machine | Date/code/variation | 1 | Y | 12 months | Packaging |
| Box Packing | 装箱机 | Box Packing Machine | Auto insert + manual | 1 | Y | 12 months | Packaging |
| Weighing Machine | 称重机 | Weighing Machine | Content check | 1 | Y | 6 months | Packaging |
| Shrink Wrapper | 热缩覆膜机 | Thermo-Shrinking Film Wrapper | 12-box brick | 1 | N | 12 months | Packaging |
| Humidity Chamber | 恒湿箱 | Humidity Storage Cabinet | 20% RH ±2% | 3 | Y | Quarterly (RH) | Warehouse |
| Analytical Balance | 分析天平 | Analytical Balance | 0.1 mg | 2 | Y | 6 months | Lab |
| pH Meter | pH计 | pH Meter | ±0.01 | 1 | Y | 6 months | Lab |
| Conductivity Meter | 电导率仪 | Conductivity Meter | Range to enzyme spec | 1 | N | 12 months | Lab |
| Micropipettes | 微量移液器 | Adjustable Micropipettes | 0.5–10 µL / 10–100 µL | Set | Y | 6 months | Lab |
| Refrigerated Storage | 冷藏柜 | Enzyme & reagent fridge | 2–8°C | 2 | Y | Continuous temp log | Lab |
| Desiccator | 干燥器 | Desiccator | Silica regeneration | 2 | N | Visual weekly | Lab |
| Packaging Scale | 包装电子秤 | Packaging Electronic Scale | 0.01 g | 2 | Y | 12 months | Packaging |
4. Critical Equipment Definition / 关键设备定义¶
Critical = Direct product quality impact (electrochemical response, dimensional integrity, reagent stability, labeling accuracy).
5. Calibration & Maintenance / 校准与保养¶
- Maintain a matrix mapping each equipment ID to calibration certificates.
- Out-of-tolerance triggers deviation record and product hold.
6. Change Control / 变更控制¶
Any replacement or spec change requires Engineering + QA approval; update this list (revision bump) and related SOP sections.
7. Records / 记录¶
- Equipment Master Register (EMR)
- Calibration Certificates Archive (digital & hardcopy)
- Preventive Maintenance Logs
8. Appendices / 附录¶
A. Equipment Tag Format
B. Sample Calibration Log
Revision History: v1.0 Initial release.