High-Level Process Flow¶

Version: v1.0

1. Purpose¶

Provide a visual & textual overview of end-to-end glucose test strip manufacturing flow from raw materials to finished packaged product.

2. High-Level Stages¶

Environment Classifications¶

• Material Preparation Room: ISO-9
• Test Strips Production Site: ISO-7, Humidity <20%
• Packing Room: Controlled

Production Stages¶

1. Material Preparation (L1/L2/L3) — ISO-9
2. L1 Electrode Printing & Drying
3. L2 Protective Film, Die Cutting
4. L3 Decorative Printing & Die Cutting
5. L1+L2 Lamination
6. Enzyme Solution Preparation
7. Line 1: Dispense, Dry @50°C, Vision — ISO-7
8. Line 2: L1/L2/L3 Lamination + NG Mark + Row Cut — ISO-7
9. Line 3: 6mm Slitting, Vial Fill, Press Cap, Weigh — ISO-7
10. Interlock Pass-Through to Packing Room
11. Line 4: Label, Box, Weigh, Shrink — Packing Room
12. CoA & Ship

3. Production Flow Diagram¶

graph TD
subgraph ISO9["Material Prep Room (ISO-9)"]
    A[Raw Materials] --> L1_start[L1: Die Cut]
    A --> L2_start[L2: Apply Protective Film]
    A --> L3_start[L3: Screen Print Logo 2-color]

    L1_start --> L1_print[L1: Screen Print Electrodes]
    L1_print --> L1_dry[L1: Dry 130°C Tunnel+Vertical]
    L1_dry --> L1_vision[L1: Vision + QR Code]
    L1_vision --> L1_store[L1: Store @20% RH]

    L2_start --> L2_cut[L2: CCD Die Cut A+B]
    L2_cut --> L2_store[L2: Store @20% RH]

    L3_start --> L3_dry[L3: Dry 130°C Tunnel+Vertical]
    L3_dry --> L3_cut[L3: Die Cut]
    L3_cut --> L3_store[L3: Store @20% RH]

    L1_store --> Combine_L1L2[Combine L1+L2 @130°C 0.4MPa]
    L2_store --> Combine_L1L2
    Combine_L1L2 --> HotRoll_AB[Hot Roll A:130°C B:120°C]
    HotRoll_AB --> L1L2_store[L1/L2 Combined: Store @20% RH]
end

Enzyme[Enzyme Solution Prep] --> Line1_dispense

subgraph ISO7["Production Site (ISO-7, <20%RH)"]
    L1L2_store --> Line1_film[Line 1: Remove Film + Frame]
    Line1_film --> Line1_dispense[Line 1: Dispense 3µL ×300 cells]
    Line1_dispense --> Line1_dry[Line 1: Dry 50°C 30min]
    Line1_dry --> Line1_return[Line 1: Return Frame + Store]
    Line1_return --> Line1_vision[Line 1: Vision Check NG→DB]
    Line1_vision --> L1L2_enzyme[Accepted L1/L2 + Enzyme]

    L1L2_enzyme --> Line2_combine[Line 2: Combine +L3 @120°C pin pos]
    L3_store --> Line2_combine
    Line2_combine --> Line2_hotroll[Line 2: Hot Roll 120°C]
    Line2_hotroll --> Line2_punch[Line 2: NG Mark]
    Line2_punch --> Line2_rowcut[Line 2: 30mm Row Cut + Split]
    Line2_rowcut --> All_rows[All Rows → Store Good/Partial/NG]

    All_rows --> Line3_slit[Line 3: 6mm Slitter manual mode for partial]
    Line3_slit --> Line3_vial[Line 3: Strips slide into Vials]
    Line3_vial --> Line3_cap[Line 3: Press Cap]
    Line3_cap --> Line3_scale[Line 3: Scale Count Check]
    Line3_scale --> Interlock[Interlock Pass-Through Chamber]
end

subgraph Pack["Packing Room"]
    Interlock --> Line4_label[Line 4: Label date/code/variation]
    Line4_label --> Line4_box[Line 4: Box Pack + Manual]
    Line4_box --> Line4_weigh[Line 4: Weigh Check]
    Line4_weigh --> Line4_shrink[Line 4: Shrink Wrap 12-box]
end

Line4_shrink --> Ship[CoA + Ship]

4. Interfaces¶

5. Change Impact¶

Any process flow change requires revision of affected SOP numbers & quality risk assessment.

Revision History: v1.0 Initial release.