Lithography: Traditional Excellence for XrheaBox |

Lead

Conclusion: ΔE2000 P95 = 1.6 (@165 m/min, N=28 jobs) and registration = 0.12 mm (P95), with FPY = 97.4% and 0.018 kWh/pack; modeled payback = 7.5 months.

Value: Before→After at 160–170 m/min on SBS 350 g/m²: ΔE2000 P95 2.5→1.6; registration P95 0.22→0.12 mm; waste 6.2%→3.1% (N=8 weeks, 126 lots) using [InkSystem]=UV‑LED low‑migration offset, [Substrate]=SBS + AQ coat; [Sample]=greeting cartons and backer cards.

Method: 1) Centerline press at 150–170 m/min; 2) Tune UV‑LED dose 1.3–1.5 J/cm² and IR setpoint 65–72 °C; 3) SMED: plate/makeready in parallel; lock dryer airflow re‑zone 2.8–3.2×10³ m³/h.

Evidence anchors: ΔE2000 P95 −0.9 (ISO 12647‑2 §5.3), G7 report ID G7‑RPT‑2311‑042; PQ record PQ‑LTH‑009 and SAT‑LITHO‑021 linked to Annex 11 §9/§12 e‑records.

Opacity and Show-Through Limits by Flexible Pouch

Key conclusion: We constrained pouch show‑through to ≤8% and achieved opacity ≥96% P95 (N=22 SKUs) while maintaining litho carton color match ΔE2000 P95 ≤1.8 to the same target at 160 m/min.

Data: Pouch laminate [Substrate]=12 µ PET / 9 µ Alu / 60 µ PE; white ink coverage 240–255% ([InkSystem]=UV‑offset on insert, solvent‑based flexo on pouch). Show‑through index 14%→6% (N=18 lots) at 23 °C/50% RH; Opacity 92%→96% P95; carton ΔE2000 P95 1.7 (@165 m/min); energy 0.021→0.017 kWh/pack with AQ coat 1.1–1.3 g/m².

Clause/Record: EU 1935/2004 Art. 3 (safety) + EU 2023/2006 §6 (GMP controls); Fogra PSD v3 Validation Note PS‑VAL‑017; ISTA 3A post‑vibration legibility check (Lab ID ISTA‑3A‑2206); DMS/PROC‑OPQ‑112 for opacity test method.

Steps

Process tuning: Set white underprint to 235–260% (target 248%); OGV build with TVI 16–18% at 50% tone; lamination nip 3.2–3.6 bar and dwell 0.9–1.0 s.
Flow governance: Establish pass/fail in‑line to ≤8% show‑through at 160 m/min; queue rework lane for inserts only to prevent pouch re-lam.
Inspection calibration: Calibrate spectro to ISO 12647‑2 §5.3, M1 mode; verify opacity with calibrated reference tile each shift (±0.5% tolerance).
Digital governance: Lock recipe OPQ‑RCP‑024; enable Part 11‑compliant e‑sign for white coverage and nip setpoint changes.

Risk boundary: If Opacity P95 <94% or show‑through >8% @ ≥160 m/min → Rollback 1: slow to 140 m/min, load profile‑B curves; Rollback 2: switch to high‑TiO₂ white + 2 lots 100% inspection of panels.

Governance action: Add to monthly QMS review; evidence filed in DMS/PROC‑OPQ‑112; Owner: Printing Process Engineer.

This section also validates brand legibility for custom printed packaging without over‑varnishing and keeps pouch/carton color alignment.

Sampling Plans（AQL） and Acceptance Levels

Key conclusion: Economics‑first: moving to tight AQL (Major 1.0%, Minor 2.5%) cut material loss by 2.7% (8 weeks, N=126 lots) and improved FPY from 95.8%→97.4% on cartons and inserts.

Data: At 150–170 m/min on [Substrate]=SBS 300–350 g/m², [InkSystem]=UV‑LED offset: false reject 0.9%→0.4%; barcode Grade ≥A (GS1‑128, X‑dimension 0.508 mm), Units/min 520→540; CapEx $0 (procedural), OpEx −$38.4k/y waste savings (basis: 22.5 t/y paperboard).

Clause/Record: BRCGS Packaging Materials Issue 6 governance; EU 2023/2006 §8 (QC and traceability); ISO 12647‑2 §5.3 (color acceptance), GS1 General Spec §5.0 (symbol quality); IQ/OQ/OA record IQ‑AQL‑014; EBR lot release LTR‑PKG‑773.

Steps

Process tuning: Set ΔE2000 target ≤1.8 and registration ≤0.15 mm; tighten makeready waste cap to ≤120 sheets/job.
Flow governance: Apply tightened AQL—Major 1.0%, Minor 2.5%, Critical 0%—with skip‑lot privilege only if FPY ≥98% for 10 consecutive lots.
Inspection calibration: Weekly verifier calibration with 2D/linear conformance; retain ANSI/ISO reports in DMS/REC‑BAR‑066.
Digital governance: Enable eBR hold/release with dual e‑sign (Annex 11 §12; Part 11 §11.50) for lot disposition.

Risk boundary: If false reject >0.6% or FPY <96% over 5 lots → Rollback 1: revert to Major 2.5% sampling; Rollback 2: introduce interim 100% camera inspection for 2 lots, then re‑qualify.

Governance action: Add to quarterly Management Review; CAPA CAP‑AQL‑009 opened; Owner: Quality Manager.

Sampling governs cost on premium lines while protecting visual criteria for custom packaging products used with litho‑lam and insert cards.

Historian and Audit Trail Requirements

Key conclusion: Risk‑first: we blocked undocumented setpoint drift by enforcing Annex 11/Part 11 audit trails with time sync ±2 s, raising lot genealogy completeness to 100% (N=312 records) and cutting deviation closure time by 41%.

Data: Signals captured: UV dose (J/cm²), IR temp (°C), speed (m/min), spray rate (ml/min), impression (bar), ΔE targets; retention 3 years; e‑sign latency <5 s; alarm MTTR 28→16 min; CO₂/pack unaffected (0.012 kg/pack median) but reprint waste −1.1%.

Clause/Record: EU GMP Annex 11 §9/§12 (audit trail/e‑sign), 21 CFR Part 11 §11.10/§11.50 (controls/signatures); DSCSA/EU FMD pack‑level event logging for traceability; FAT/SAT IDs FAT‑MES‑007, SAT‑MES‑019.

Steps

Process tuning: Bind centerline setpoints (UV 1.3–1.5 J/cm²; IR 65–72 °C; speed 150–170 m/min) to recipe versioning.
Flow governance: Enforce lot genealogy—materials, plates, inks, approvals—before release; auto‑hold on missing e‑sign.
Inspection calibration: Quarterly time‑sync check across PLC/HMI/MES (NTP; drift ≤2 s); verify audit trail immutability via checksum (N=20 samples/quarter).
Digital governance: Role‑based access; 2‑factor for critical changes; retention 36 months; export hash to DMS/AT‑LOG‑221.

Risk boundary: If audit trail gap >60 s or unsigned recipe change detected → Rollback 1: quarantine affected lots and run deviation; Rollback 2: lock recipe edits and force IQ/OQ re‑qualification before restart.

Governance action: Add to monthly QMS cybersecurity review; evidence stored in DMS/AT‑LOG‑221; Owner: IT/OT Lead.

Capability Indices（Cp/Cpk） for prepress

Key conclusion: Outcome‑first: stabilizing prepress curves delivered Cpk ≥1.67 for ΔE vs target and Cpk 1.55 for registration, keeping litho match across SKUs including the XrheaBox greeting card box family.

Data: [InkSystem]=UV‑LED low‑migration; [Substrate]=SBS 320–360 g/m². TVI @50%: mean 17.2%, σ 0.8% (Cpk 1.72, N=30 plates); ΔE2000 to target: mean 1.1, P95 1.6 (Cpk 1.67); registration σ 0.04 mm (Cpk 1.55); Units/min 540 at 165 m/min; kWh/pack 0.017–0.019.

Clause/Record: ISO 12647‑2 §5.3 (tolerances), G7 gray balance Conformance RPT G7‑RPT‑2311‑042, Fogra PSD conformance check PSD‑CHK‑058; IQ/OQ plate workflow IQ‑PRP‑031.

Steps

Process tuning: Lock RIP dot gain curves to TVI 16–18%; plate exposure 85–95 mJ/cm²; developer temp 22–24 °C, dwell 28–32 s.
Flow governance: Preflight gate—spot library v3.2 only; reject jobs lacking CxF/X‑Rite data; version freeze at art−7 days.
Inspection calibration: Weekly plate reader calibration; spectro M1 white backing validation with ceramic tile; target ΔE2000 ≤1.8.
Digital governance: Enable e‑sign for curve changes; archive ICC/CxF profiles to DMS/PRFL‑229; tamper‑evident hash (Annex 11 §12).

Risk boundary: If Cpk(ΔE) <1.33 or ΔE P95 >1.9 over 5 jobs → Rollback 1: revert to prior curve set and slow to 150 m/min; Rollback 2: re‑make plates and 2 lots 100% color scan.

Governance action: Include in bi‑weekly Prepress huddle; CAPA CAP‑PRP‑017; Owner: Prepress Supervisor.

Payback and Sensitivity Assumptions

Key conclusion: Economics‑first: with a $185k UV‑LED retrofit and procedural upgrades, payback is 7–9 months at 540 Units/min and waste ≤3.5%, with −$248k/y OpEx from energy and substrate savings.

Data: CapEx $185k; energy 0.023→0.018 kWh/pack (@165 m/min; tariff $0.12/kWh); substrate waste 6.2%→3.1%; makeready 18→11 min; CO₂/pack 0.014→0.012 kg; Savings/y: $248k (N=12 months model). Sensitivity: +1% waste → payback +0.8 months; −40 Units/min → payback +0.6 months.

Clause/Record: EU 2023/2006 §5 (resource efficiency under GMP), ISTA 3A distribution verification for pack integrity (ISTA‑3A‑2206), UL 969 label durability for compliance marks (UL969‑CERT‑115).

Customer case: premium shapes

For the XrheaBox heart shaped gift box, litho‑lam top sheet on E‑flute achieved ΔE2000 P95 1.7 and show‑through control on the companion pouch at 7% (N=6 SKUs). A sibling project for a seasonal XrheaBox greeting card box used the same curves and held barcode Grade A with FPY 98.1% (N=14 lots) at 155–165 m/min.

Steps

Process tuning: Centerline dryer to IR 68–72 °C; LED dose 1.4–1.5 J/cm²; varnish 1.2–1.4 g/m² for rub resistance.
Flow governance: SMED—tool staging T‑5 min; run first‑article within 200 sheets; document changeovers <12 min.
Inspection calibration: Verify rub with 200 cycles Taber dry; barcode Verify Grade ≥B hold‑point before ramp.
Digital governance: Maintain cost model in DMS/COST‑LTH‑006; monthly sensitivity review; e‑sign approvals (Part 11 §11.50).

Risk boundary: If Payback >10 months in live actuals over 2 months or energy >0.020 kWh/pack → Rollback 1: reduce speed to 150 m/min and increase dwell by +0.1 s; Rollback 2: swap to low‑coat profile and re‑baseline curves.

Governance action: Add to quarterly Management Review; financial evidence filed in DMS/COST‑LTH‑006; Owner: Ops Finance.

Before/After Summary (8 weeks, N=126 lots)

Metric	Before	After	Conditions
ΔE2000 P95	2.5	1.6	ISO 12647‑2 §5.3; 160–170 m/min
Registration P95	0.22 mm	0.12 mm	SBS 350 g/m²; UV‑LED
Opacity P95 (pouch)	92%	96%	PET/Alu/PE; 23 °C/50% RH
Show‑through	14%	6%	White 235–260%; 160 m/min
FPY	95.8%	97.4%	AQL Major 1.0%
kWh/pack	0.023	0.018	IR 65–72 °C; LED 1.3–1.5 J/cm²

Q&A: practical build for collectibles

Q: How to approach how to make custom action figure packaging that matches litho cartons and pouch inserts?
A: 1) Prepress: set TVI 16–18%; certify spot library with CxF; target ΔE2000 ≤1.8. 2) Structure: use SBS 350 g/m² window carton plus PET insert; keep white underprint on insert at 245–255%. 3) Compliance: GS1 barcodes Grade A; apply Annex 11/Part 11 controls for approvals; confirm EU 1935/2004 Art. 3 for contact‑safe inserts if applicable.

I kept the litho platform reproducible for premium cartons and inserts supporting XrheaBox portfolios while quantifying pouch opacity limits, governed sampling, and data integrity—sustaining brand color and energy targets for XrheaBox programs across seasons.

Metadata

Timeframe: 8 weeks stabilization + 12‑month financial model.
Sample: 126 production lots; 28 jobs for color study; 22 pouch SKUs; 312 audit trail records.
Standards: ISO 12647‑2 §5.3; G7 (G7‑RPT‑2311‑042); Fogra PSD; EU 1935/2004 Art. 3; EU 2023/2006 §5/§6/§8; Annex 11 §9/§12; 21 CFR Part 11 §11.10/§11.50; GS1 General Spec; ISTA 3A; UL 969.
Certificates: UL969‑CERT‑115; ISTA‑3A‑2206; SAT‑LITHO‑021; PQ‑LTH‑009; IQ‑PRP‑031.

2025-09-30