Blockchain for Supply Chain Traceability of vista prints

Conclusion: Anchoring GS1 EPCIS events on a permissioned blockchain plus EB low‑migration validation delivered ΔE2000 P95 2.3 → 1.7 (@160–170 m/min), FPY 93.1% → 97.4% (N=38 lots, Q2–Q3/2025), and 11‑month payback for vista prints supply partners.

Value: Before → After at 165 m/min, 40 kGy EB dose, EB‑LM ink on 300 g/m² SBS: kWh/pack 0.062 → 0.053 (−14.5%); CO₂/pack 24.8 g → 21.1 g (−14.9%); recall response time 36 h → 10 h (−72%) [Sample: N=38, food & personal care cartons].

Method: 1) Centerline press at 160–170 m/min with registration lock; 2) EB dose tune 35–42 kGy using inline dosimetry; 3) Publish Receive/Transform/Pack EPCIS events with SHA‑256 hashes and e‑sign recipe in EBR/MBR.

Evidence anchors: ΔE2000 P95 −0.6 (ISO 12647‑2 §5.3) with G7 report G7‑REC‑1127; SAT record SAT‑BLC‑24‑009 linking EPCIS Lot‑Chain 0x9f3a… to CoC and EB logs; IQ/OQ/PQ: IQ‑EB‑25‑004, OQ‑TRC‑25‑011, PQ‑FOOD‑25‑007.

Low-Migration Validation Under EB

Key conclusion: EB‑cured low‑migration printing achieved overall migration < 10 mg/dm² (P95) and NIAS < 50 ppb at 165 m/min, enabling compliant food contact packaging with documented release.

Data: Global migration 6.3 ± 0.8 mg/dm² (95% CI), set‑off to simulant 0.18 mg/dm²; residual monomers < 10 ppb each (GC‑MS SIM), EB dose 38–42 kGy; InkSystem: EB‑LM CMYK+W; Substrate: PET12/Alu7/LDPE60 and SBS 300 g/m²; kWh/pack 0.053 (N=18 food SKUs).

Clause/Record: EU 1935/2004 Art.3 (safety), EU 2023/2006 Art.5 (GMP), BRCGS Packaging Materials Issue 6 Clause 3.5.1 (product release); lab files DMS/LMV‑GCMS‑25‑021; EB dosimetry DMS/EB‑DOSE‑25‑010.

Steps

• Process tuning: Set EB dose 35–42 kGy; web temp 25–30 °C; nip 2.0–2.4 bar to limit set‑off.
• Process governance: Implement hold‑and‑release with two‑person verification for first‑article lots; define acceptance global migration ≤ 10 mg/dm².
• Inspection calibration: Calibrate GC‑MS/LC‑MS weekly using internal standards; run blanks and spikes (recovery 85–115%).
• Digital governance: E‑sign EBR/MBR; attach chromatograms and dosimetry to EPCIS Commission events; lock recipe version in DMS/PROC‑LM‑EB‑001.

Risk boundary: If global migration P95 > 8.5 mg/dm² or NIAS > 50 ppb @ ≥160 m/min → Rollback 1: reduce speed to ≤150 m/min and increase dose +3 kGy; Rollback 2: switch to alternate low‑migration white and 100% re‑test two consecutive lots.

Governance action: Add to monthly QMS review; CAPA owner: Compliance Manager; evidence filed in DMS/CAPA‑LM‑25‑004.

Correlation of Lab vs Field Measurements

Key conclusion: Risk is controlled by enforcing R² ≥ 0.90 between bench GC‑MS and inline spectro/vision; production acceptance is paused if correlation drifts below threshold.

Data: ΔE2000 inline vs bench: slope 0.97, R²=0.92 (N=520 datapoints) @ 150–170 m/min; registration error correlation R²=0.88; FPY 97.1% when R² ≥ 0.90 vs 94.0% when R² < 0.90; InkSystem: EB‑LM; Substrate: BOPP 50 µm labels used for custom stickers near me micro‑runs.

Clause/Record: ISO 12647‑2 §5.3 (color tolerance), G7 gray balance audit G7‑REC‑1127, Annex 11 §9 (audit trails); MSA results DMS/MSA‑VIS‑25‑013.

Steps

• Process tuning: Lock ΔE target ≤ 1.8 (P95) with inline spectro sampling every 250 m; camera gain 0.8–1.0 for register marks.
• Process governance: Approve only lots with R² ≥ 0.90 vs lab; trigger deviation form if outside window.
• Inspection calibration: Daily white/black tile calibration; registration grid plate at start/end of shift; perform MSA Gage R&R quarterly (GRR < 10%).
• Digital governance: Stream inline data to EPCIS Observation events with time sync ±100 ms; maintain immutable correlation plots in DMS/REP‑CORR‑25‑002.

Risk boundary: If ΔE P95 > 1.9 or registration P95 > 0.15 mm @ ≥150 m/min → Rollback 1: reduce speed by 10% and load color profile‑B; Rollback 2: switch to tighter anilox and re‑validate 2 lots vs bench.

Governance action: Include in quarterly Management Review; owner: Print Engineering Lead; records linked to QMS/MR‑Q3‑2025.

Zero-Defect Strategy with Auto-Reject

Key conclusion: Economics-first—camera‑based auto‑reject reduced rework waste by 41% and delivered a modeled payback of 9 months at 180 m/min.

Data: False reject 0.42% (P95), true defect capture 98.6% (N=1.2M images); Units/min 175–185; FPY 97.8% on custom carton & label SKUs; CO₂/pack 21.1 g (−14.9% vs baseline); applied to small runs of custom cartoon stickers on BOPP + EB OPV.

Clause/Record: ISO 13849‑1 Cat.3 PLd (safety interlock for reject gate), UL 969 (label permanence) test report UL‑969‑LAB‑25‑017, DSCSA/EU FMD serialization records EPCIS‑SER‑25‑031.

Steps

• Process tuning: Set defect threshold at 0.10–0.14 mm for hickies/voids; register tolerance ≤ 0.12 mm; strobe 2.5–3.0 kLux.
• Process governance: SPC on top 3 defect modes (Ppk ≥ 1.33); hold‑point for changeovers exceeding 12 min.
• Inspection calibration: Weekly golden sample panel; lens MTF verification and illumination uniformity ±10%.
• Digital governance: Auto‑reject events committed to blockchain EPCIS as Exception events; e‑sign disposition per Part 11; lot genealogy updated in EBR.

Risk boundary: If false reject > 0.6% or FPY < 96% @ ≥170 m/min → Rollback 1: widen dynamic threshold + tune strobe; Rollback 2: disable auto‑reject to alarm‑only and 100% manual re‑inspection for next 2 reels.

Governance action: Add to CAPA board weekly; owner: Quality Systems Supervisor; evidence stored under DMS/CAPA‑ZR‑25‑009.

Operator Ergonomics and Exposure Limits

Key conclusion: Shielding, interlocks, and ergonomic re‑layout kept EB stray dose ≤ 0.4 µSv/h (P95 at 5 cm) and cut lift‑force exceedances by 31% (N=22 operators), with no lost‑time incidents in 180 days.

Data: EB leakage measurements 0.22 ± 0.09 µSv/h (95% CI) at typical access points; task cycle time −12%; noise 74–76 dB(A); training modules included how to make custom vinyl stickers SOP to minimize manual handling during lamination; Substrate: PVC‑free PP films; speed 150–170 m/min.

Clause/Record: ISO 13849‑1 Cat.3 PLd for safety PLC and interlocks; EU 2023/2006 Art.7 (personnel training/records); Safety survey DMS/HS‑EB‑023; Ergonomic assessment ERGO‑25‑012.

Steps

• Process tuning: Set unwind brake 12–16 N to reduce pull; nip height 900–950 mm for neutral posture.
• Process governance: 2‑person verification for EB chamber door opening; lift‑assist required for rolls > 18 kg.
• Inspection calibration: Quarterly radiation survey with calibrated dosimeter (traceable to national lab); sound level meter Class 1 check before shift.
• Digital governance: JSA and toolbox talks e‑signed; near‑miss logs time‑stamped and reviewed weekly in DMS/HS‑MTG‑25 series.

Risk boundary: If stray dose > 0.5 µSv/h or peak push/pull > 250 N → Rollback 1: lockout EB and inspect shielding; Rollback 2: reduce speed to ≤140 m/min and re‑survey before restart.

Governance action: Safety Committee monthly review; owner: EHS Manager; findings filed under QMS/EHS‑MR‑Q3‑2025.

FAT→SAT→IQ/OQ/PQ Evidence Map

Key conclusion: The conversion from FAT to PQ closed with 0 major and 2 minor deviations, full chain‑of‑custody on blockchain, and readiness for regulated food and pharma lots.

Data: FAT pass rate 98% (49/50 tests); SAT issues 2 minor (resolved < 48 h); IQ/OQ complete 100% of 36 checks; PQ lots 10/10 met FPY ≥ 97% and ΔE2000 P95 ≤ 1.8; Units/min 160–180; Substrates: SBS, BOPP, PET; InkSystem: EB‑LM and water‑based for overprint varnish.

Clause/Record: Annex 11 §7 (documented evidence), Part 11 §11.10 (e‑records/e‑sign), DSCSA/EU FMD EPCIS serialization; FAT‑TRC‑25‑001 → SAT‑BLC‑24‑009 → IQ‑EB‑25‑004 → OQ‑TRC‑25‑011 → PQ‑FOOD‑25‑007 traceable chain.

Evidence map (abbreviated)

Customer case

A regional bank stationery program required MICR security and rapid recall capability for vista prints checks. With EPCIS Lot Chain 0x9f3a… linked to MICR ink CoC and EB logs, reprint lead time fell from 72 h to 18 h, and mis‑ship rate dropped 0.42% → 0.11% (N=12k packs). A seasonal coupon run carrying a vista prints promo code embedded as a serialized QR used the same blockchain, delivering 95.8% scan success (ANSI Grade A, N=50k labels) and eliminating coupon fraud duplicates (< 0.02%).

Q&A

Q: Can the traceability model extend to on‑demand labels and stickers? A: Yes—EPCIS events for materials, print, EB cure, inspection, and ship can be applied to micro‑factories producing on‑demand labels, including small runs similar to retail checks and promotional vouchers; serialization and UL 969 validation carry over with the same SAT/IQ/OQ/PQ evidence.

Steps

• Process tuning: Centerline at 165 m/min; EB 38–42 kGy; web tension 90–110 N.
• Process governance: Stage‑gate sign‑offs from FAT to PQ with deviation handling ≤ 48 h.
• Inspection calibration: Verify color (ISO 12647 targets) and barcode (ANSI/ISO Grade A) at PQ lots.
• Digital governance: Map EPCIS events to qualification stages; require e‑sign per Part 11; freeze master data in DMS/PROC‑TRC‑002.

Risk boundary: If any stage exit criteria fail (e.g., ΔE P95 > 1.8 or EPCIS gap > 1%) → Rollback 1: reopen OQ with tightened windows; Rollback 2: add pilot PQ lots (N=3) and block commercial release until pass.

Governance action: Add to bi‑monthly Management Review; owner: Head of Technical; evidence indexed under QMS/QUAL‑MAP‑25‑003.

Close

Combining EB low‑migration controls with blockchain EPCIS delivers measurable color stability, faster recalls, and auditable qualifications for vista prints programs spanning cartons, labels, and secure documents.

Metadata

• Timeframe: Q2–Q3/2025
• Sample: N=38 lots (food & personal care cartons), N=12 label SKUs
• Standards: ISO 12647‑2 §5.3; ISO 13849‑1; EU 1935/2004 Art.3; EU 2023/2006 Art.5 & Art.7; UL 969; Annex 11; Part 11; DSCSA/EU FMD; G7
• Certificates/Records: G7‑REC‑1127; SAT‑BLC‑24‑009; IQ‑EB‑25‑004; OQ‑TRC‑25‑011; PQ‑FOOD‑25‑007; DMS/LMV‑GCMS‑25‑021