Line 1 Work Instruction (Enzyme Dispense, Dry, Vision)¶
Version: v1.0
1. Purpose¶
Standardize dispensing of enzyme solution onto L1/L2 assemblies, controlled drying, and initial vision inspection.
2. Scope¶
Applies to semi-automatic Line 1 operations in ISO-7 environment (<20% RH): enzyme dispensing machine, automatic enzyme drying oven, and vision analyzer.
3. Responsibilities¶
Operators follow steps; QA reviews vision defect mapping integrity.
4. Equipment¶
- Automatic Enzyme Dispensing Machine (3 µL ±2%)
- Automatic Enzyme Drying Oven (50°C, 30 min cycle)
- NG Computer Vision Analyzer + QR Code Printer
- Humidity Storage Cabinet (20% RH)
5. Inputs¶
- Accepted L1/L2 laminated assemblies (clean, within spec)
- Released enzyme solution lot (see SOP 04)
6. Procedure¶
| Step | Description | Detail / Notes | Record |
|---|---|---|---|
| 1 | Preparation | Verify equipment status & calibration | Pre-check form |
| 2 | Load material | Remove protective film from L1/L2; place in aluminum frame | Batch record |
| 3 | Frame loading | Place frame with L1/L2 onto Line 1 fixture (continuous) | Batch record |
| 4 | Set dispense parameters | Load volume 3.0 µL, pattern coordinates | Machine log |
| 5 | Execute dispense | Start cycle; dispense enzyme into 300 cells | Visual check |
| 6 | Initial check | Confirm uniform droplet shape (spot diameter tolerance) | Sampling sheet |
| 7 | Dry transfer | Automatic transfer to Automatic Enzyme Drying Oven | Auto timestamp |
| 8 | Drying control | 50°C for 30 minutes | Oven chart |
| 9 | Oven release | After release, manually remove frame; place on conveyor back to stage 1 | Batch record |
| 10 | Storage | Store L1/L2 with dried enzyme solution | Storage log |
| 11 | Vision inspection | Load frame in analyzer; scan enzyme edges, bubbles, sensor structure | Vision system DB |
| 12 | QR coding | Print QR linking defect map to L1 ID | Vision DB |
| 13 | Defect classification | Classify: Enzyme spread, bubble, missing area, structure | Defect code list |
| 14 | Accepted storage | Store accepted frames @20% RH | Storage log |
7. Acceptance Criteria¶
| Parameter | Requirement |
|---|---|
| Volume | 3.0 µL ±2% |
| Spot Diameter | Defined range (specify) |
| Bubble Count | 0 allowed in active area |
| Edge Uniformity | ≥95% cells pass |
8. Defect Codes¶
| Code | Description |
|---|---|
| E1 | Under-volume |
| E2 | Over-volume |
| E3 | Bubble inclusion |
| E4 | Spread beyond boundary |
| E5 | Missing dispense |
9. Records¶
- Line 1 Batch Record
- Vision Analyzer Export (defect coordinates + QR mapping)
- Oven Temperature Chart
10. Reaction Plan¶
5% cells E3 or E4: pause line; inspect nozzle & humidity. >2% E5: recalibrate dispenser.
11. Safety¶
Warm hazard at oven exit (50°C); handle frames carefully; avoid direct skin contact with wet enzyme solution.
Revision History: v1.0 Initial release.