Blockchain in Supply Chain: Case Study on Cold Chain and Temperature-Sensitive Goods

Summary: Decision-makers can now combine blockchain, EPCIS 2.0, verifiable credentials, and sensor attestation to prove temperature integrity, chain-of-custody, and regulatory compliance for food, pharma, and cell/gene therapies across geographies. This post distills the latest standards, mandates, and field-tested architectures you can implement in 90 days.

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Why cold chain traceability is different (and hard)

Temperature-sensitive goods fail silently. A pallet that drifts from 2–8°C for 30 minutes can appear normal on receipt yet trigger recalls, potency loss, or waste weeks later. For decision-makers, the bar isn’t “track-and-trace” — it’s defensible, standards-aligned evidence that:

• The product stayed within labeled ranges end-to-end (including last mile).
• Chain of custody (who) and chain of identity (what) are provable.
• Sensor data and calibration are trustworthy (device identity, not just data).
• Sharing is selective: auditors see everything; partners see only what they need.

The good news: 2024–2025 brought the missing building blocks — EPCIS 2.0 sensor events, DSCSA/FSMA momentum, verifiable credentials (VC 2.0), and IoT attestation (IETF RATS/EAT). You can assemble them into a production-grade stack now. (gs1.org)

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Regulatory backdrop you must design for (U.S. focus)

• Pharma (DSCSA): FDA created a stabilization period ending Nov 27, 2024, then issued phased exemptions moving practical enforcement for large trading partners into 2025 (manufacturers May 27; wholesalers Aug 27; larger dispensers Nov 27). Small dispensers have an exemption to Nov 27, 2026. Don’t treat this as a delay — systems must be interoperable and electronic. (fda.gov)

• Food (FSMA 204): FDA proposed extending the compliance date 30 months (to July 20, 2028) via a 2025 rulemaking; FDA and trade groups also indicated routine inspections would begin in 2027 even before the proposed extension was finalized. Plan for standardized electronic records and 24-hour data access. (govinfo.gov)

• USP 1079 series: New chapters formalize temperature mapping for storage areas (<1079.4 official May 1, 2024), add guidance on monitoring devices (<1079.3), mean kinetic temperature for excursions (<1079.2), and introduce forthcoming transport-lane qualification. These are increasingly referenced by auditors. (lachmanconsultants.com)

• Cell & gene transport: ISO 21973:2020 sets general requirements for transport of cells for therapeutic use (documentation, validation, monitoring, and communication). (iso.org)

• Calibration: NIST’s traceability policy reminds us an “unbroken chain” of calibrations with stated uncertainties is required; ISO/IEC 17025 governs competence of labs issuing calibration certificates. Treat calibration proofs as first-class data. (nist.gov)

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Case studies with fresh, concrete lessons

1) NHS last-mile vaccine monitoring with immutable event logs

Everyware, working with UK NHS facilities, logs temperature events for sensitive vaccines (2–8°C in storage; ultra-cold inbound) and anchors ordered, timestamped events to the Hedera Consensus Service for tamper-evidence and rapid incident response. This pattern shows how to anchor high-frequency IoT streams at low cost without moving raw data on-chain. (hedera.com)

Key takeaways you can reuse:

• Immutable ordering/timestamps on a public ledger builds trust across multi-party cold chains (3PL → hospital → pharmacy).
• Keep raw logs off-chain; write batched hashes (Merkle roots) to chain each 5–15 minutes.
• Give each device (or logger batch) its own key material to bind data to the hardware identity.

2) APAC vaccine traceability at scale (eZTracker, Zuellig Pharma)

Zuellig and GSK launched a Singapore-based hub serving 13 markets, using eZTracker to verify vaccine provenance and authenticity at the point of care, and shifting to lower-carbon sea transport where possible. The system has operated in Hong Kong, Thailand, and the Philippines since 2020, now extended and productized as eZVax. Cold chain governance + consumer/clinician verification is the differentiator — not blockchain alone. (zuelligpharma.com)

What to copy:

• Item/package-level verification for authenticity and recall handling via mobile scans.
• Blend sustainability goals (modal shift to sea) with traceability to win executive sponsorship.

3) IBM Food Trust + iFoodDS for FSMA 204 programs

IBM and iFoodDS combined a hardened traceability network (IBM Food Trust) with FSMA 204 capture/validation workflows (Trace Exchange). If you’re a large food enterprise, this is a benchmark for onboarding suppliers and normalizing data before inspections begin. (newsroom.ibm.com)

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The stack that works in 2025

Design your cold chain stack around these standards and interfaces:

1. Identify “things” and events with GS1 EPCIS 2.0:

   • EPCIS 2.0 adds JSON/JSON-LD, REST APIs, and built-in SensorElements for condition data (temperature, humidity, shock). Aligns with DSCSA and FSMA 204 data-exchange goals. (gs1.org)

2. Prove device integrity using IoT attestation (IETF RATS/EAT):

   • Have loggers or gateways produce EAT tokens (JWT/CBOR) with hardware-backed claims (secure element, firmware version, boot state). This ties readings to a genuine device state. (rfc-editor.org)

3. Package people/organization proofs with W3C Verifiable Credentials 2.0:

   • Issue VCs for sensor calibration certificates (ISO/IEC 17025), lane qualifications (USP 1079.5 when adopted), and Authorized Trading Partner (ATP) status for DSCSA using OCI. VC 2.0 reached W3C Recommendation in May 2025, making multi-vendor interop real. (w3.org)

4. Share access via GS1 Digital Link and digital signatures:

   • Use one 2D barcode (DataMatrix/QR) with Digital Link to route regulators and partners to the right data and use GS1 Digital Signatures to protect on-pack data integrity. (gs1.org)

5. Anchor evidence on a public or consortium ledger:

   • Batch-and-anchor EPCIS event digests and time-series temperature hashes, not raw logs. This yields tamper-evidence and auditability without cost explosions.

6. Store logs on verifiable storage:

   • Pair IPFS CIDs for integrity with Filecoin storage (consider new Proof of Data Possession for hot/warm datasets) to meet retrieval SLAs while preserving verifiability. (docs.ipfs.tech)

7. Interoperate with DSCSA’s VRS and OCI:

   • For pharma, integrate your EPCIS+ledger stack with VRS (Verification Router Service) and OCI ATP credentials. Performance test suites demonstrated sub-second roundtrips with credentials — crucial for saleable returns and suspect-product workflows. (oc-i.org)

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Reference architecture (practical and deployable)

• Edge layer
  • Calibrated BLE/LoRaWAN/NB-IoT data loggers every 5 minutes; secure element (e.g., ATECC608A or NXP SE050) holds device keys and signs payloads; optional gateway adds EAT attestation claims. (microchip.com)
• Ingestion and normalization
  • MQTT/HTTPS to your ingestion service; verify device signatures; translate readings to EPCIS 2.0 ObjectEvent/TransformationEvent with SensorElement.
• Evidence machine
  • For each shipment, roll readings into hourly Merkle roots; store full logs in object storage + IPFS/Filecoin; anchor hourly roots to a ledger; write attestation receipts back to EPCIS as persistent “evidence URIs.” (docs.ipfs.tech)
• Identity & credentials
  • Maintain a credential wallet for: ISO/IEC 17025 calibration VCs, DSCSA ATP credentials (OCI), lane/shipping system qualifications (USP 1079.4/.5), and auditor permits. (iso.org)
• Access control
  • Resolve a GS1 Digital Link QR/DataMatrix to a policy-controlled presentation of VCs, signed PDFs, EPCIS queries, and cryptographic proofs. (gs1.org)
• Pharma extras
  • Support VRS APIs for product verification and OCI checks for ATP status; align with GS1 US DSCSA Implementation Suite (Release 1.3 sunrise beginning 2026). (gs1us.org)

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What “good” looks like in production

• Evidentiary temperature integrity
  • For each unit/case/pallet, produce: a signed summary (min/max/mean), EPCIS SensorElements, an excursion report with MKT where applicable (<1079.2), a calibration VC chain to NIST traceability, and a ledger receipt for tamper-evidence. (uspnf.com)
• Multilevel sharing
  • Give dispensers and retailers a compact dossier; regulators get full logs + proofs within 24 hours (FSMA/DSCSA expectation).
• Provable device trust
  • Each reading tied to device identity (secure element serial) and attestation (EAT). If firmware changes, claims show it.
• Recall efficiency
  • EPCIS+Digital Link supports targeted recalls — you fetch only affected lots/traceability codes, not entire categories. (gs1.org)

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Cold chain–specific patterns (with numbers)

• Sampling and costs

  • Typical pharma/food shipments record every 5 minutes for 3 days → ~864 readings/day → ~2,592 readings/shipment. With 1,000 shipments/month: ~2.6M readings.
  • Batch hashes of 60 readings (5 hours) into one Merkle leaf; write 5–6 leaf roots/hourly → 72 anchors/shipment. In practice, aggregate to one anchor/hour per lane to cut on-chain ops by >90% while preserving auditability.

• MKT-based excursion adjudication

  • Implement business rules: discard “transient door-open” spikes if shipment MKT stays within specified range (per labeled storage); flag if MKT exceeds threshold or if any single-point violation crosses absolute limits. (uspnf.com)

• Cryogenic/ultra-cold lanes

  • For CAR‑T and other cell therapies, integrate cryogenic shipper telemetry (location, orientation, shock/tilt, pressure) and ISO 21973 documentation into the dossier; enforce “chain of identity” with VCs at handoff checkpoints. (iso.org)

• Verified partner interactions (pharma)

  • Block data exchange if counterparty ATP credential fails; VRS calls must complete sub‑second with credentials in the loop (OCI test harness shows ~1–1.5s roundtrips). (oc-i.org)

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Emerging best practices we recommend in 2025

1. Treat calibration like identity

   • Attach a VC to each logger indicating ISO/IEC 17025 lab, certificate number, uncertainty, and due date; include a NIST-traceability statement. Expired calibration = reduced assurance tier. (iso.org)

2. Hardware roots of trust at the edge

   • Use secure elements (e.g., ATECC608A, SE05x) to store keys and perform ECDSA signing on-device; pair with EAT claims for attested boot and firmware states. (microchip.com)

3. VC 2.0 everywhere

   • Standardize on VC 2.0 for ATP credentials, auditor access, calibration, and training attestations (e.g., “qualified shipper loading”). It reduces bespoke integrations and audit friction. (w3.org)

4. EPCIS 2.0 as your lingua franca

   • Keep commercial logic off-chain; make the EPCIS event stream the “system of record” for operations; anchor digests to blockchain for integrity. (gs1.org)

5. Minimize on-chain writes; maximize verifiability

   • Use hourly anchors; store logs in IPFS/Filecoin with new PDP-enabled warm storage for faster retrieval proofs. (filecoin.io)

6. DSCSA: wire up OCI and VRS now

   • Don’t wait for final enforcement. Credential your organization, test with at least two VRS providers, and confirm EPCIS 2.0 mappings. GS1 US recommends Release 1.3 with a phased sunrise beginning 2026. (gs1us.org)

7. FSMA 204: build once for 2027–2028

   • Even with proposed extension, implement standardized KDE/CTE capture, 24-hour retrieval, and EPCIS-based evidence. Use IBM/iFoodDS or an equivalent to normalize supplier data at scale. (foodlogistics.com)

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Tooling snapshot you can adopt today

• EPCIS 2.0 APIs: capture ObjectEvent/TransformationEvent + SensorElement (JSON/JSON‑LD). (gs1.org)
• OCI ATP credentials + wallet: integrate with ledger-backed credential flows for DSCSA. (oc-i.org)
• VRS: ensure your provider passed independent conformance/performance tests; target ~1s verification times with credentials. (gatewaychecker.com)
• Digital ID on labels: GS1 Digital Link + GS1 Digital Signatures to tie physical to digital. (gs1.org)
• Verifiable storage: persist logs with IPFS CIDs; store on Filecoin; keep on-chain receipts. (docs.ipfs.tech)

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Procurement-ready specs for cold-chain sensors (what to insist on)

• Accuracy and range by lane:
  • 2–8°C with ±0.3°C accuracy; -60 to -80°C dry ice range; ≤‑150°C cryogenic telemetry.
• Identity and attestation:
  • Unique hardware-backed keypair, ECDSA P‑256; optional EAT claims; signed payloads.
• Calibration:
  • ISO/IEC 17025 certificate as a VC; include uncertainty, method, due date, NIST traceability statement. (iso.org)
• Data model:
  • Native EPCIS 2.0 SensorElement fields (time, uom, range, sampling rate).
• Security and records:
  • 21 CFR Part 11–aligned audit trails and signature controls when used in regulated contexts. (fda.gov)

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90‑day pilot plan (repeatable)

• Weeks 1–2: Scope and governance

  • Pick 2 lanes (one domestic, one cross-border), one temperature band (2–8°C), and 2 partners (3PL/dispensing site).
  • Define success metrics: excursion detection time, dossier completeness (EPCIS + VC + receipts), and verification latency (VRS/OCI for pharma).

• Weeks 3–6: Instrument and integrate

  • Deploy calibrated loggers with hardware signing; stand up ingestion; map to EPCIS 2.0; enable hourly anchoring; configure IPFS/Filecoin storage; provision ATP/other credentials via OCI; add GS1 Digital Link to labels. (gs1.org)

• Weeks 7–10: Execute runs and dry drills

  • Run 25–50 shipments; simulate excursions; perform MKT analysis per <1079.2>; complete recall drill (24‑hour dossier delivery). (uspnf.com)

• Weeks 11–12: Validate & decide

  • QA evidence against ISO 21973/USP 1079.4 checklists; measure VRS/OCI latency; finalize rollout roadmap and partner onboarding plan. (iso.org)

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Brief in-depth details: specialty therapy (cryogenic) pattern

• Requirements:
  • -150°C or colder with 7–10‑day hold time; orientation/shock sensing; chain‑of‑identity controls; ISO 21973 transport plan and verification; 24/7 monitoring + intervention (e.g., Smartpak II + platform). (iso.org)
• Architecture deltas:
  • Two-factor custody handoffs (badge + VC scan); consented role-based views at clinical sites; cryo-shipper telemetry mapped as EPCIS SensorElements; hourly anchors + alert-driven on-demand anchors during excursions.
• Business rule:
  • Any tilt event beyond tolerance at transfer point triggers mandatory visual inspection and notarized event (VC), appended to dossier; payer release contingent on dossier validity.

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Risk, ROI, and what to say to your CFO

• Risk reduction: You trade “trust me spreadsheets” for cryptographic receipts and standardized dossiers that regulators understand (EPCIS + VC + ledger proof).
• Cost control: Anchoring digests hourly keeps ledger costs predictable; verifiable storage (Filecoin/IPFS) is cheaper than duplicating raw logs on-chain while adding retrieval proofs. (filecoin.io)
• Revenue protection: Faster, narrower recalls; fewer write‑offs from unprovable excursions; provable partner performance for SLA credits.

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Final checklist before you greenlight

• EPCIS 2.0 capture and query APIs live and tested with SensorElements. (gs1.org)
• OCI ATP credentials issued to you and your core partners; VRS connectivity tested. (oc-i.org)
• VC 2.0 issuer set up for calibration certificates and auditor access. (w3.org)
• Hourly anchoring pipeline with public receipts; IPFS/Filecoin storage for logs. (docs.ipfs.tech)
• USP 1079.4 storage mapping done; lane qualification plan (<1079.5) in motion; ISO 21973 in scope for cell/gene lanes. (lachmanconsultants.com)
• 21 CFR Part 11–aligned audit trails and e-signatures in your quality system. (fda.gov)

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One more thing: don’t forget the label

Put a single GS1 Digital Link 2D code on the unit/case that resolves to a policy-controlled view of:

• EPCIS event summary (who/what/when/where + SensorElement),
• Calibration VCs and ISO/IEC 17025 details,
• Ledger receipt(s) and IPFS CID(s),
• DSCSA verification (if pharma), and
• FSMA 204 KDE/CTE package (if food). (gs1.org)

That’s how you turn every physical item into a verifiable digital twin that passes audits and wins trust — without drowning your partners in integrations.

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7Block Labs builds and ships these stacks. If you want a 90‑day pilot plan tuned to your lanes and regulators, we’ll scope it with your quality and security leaders in one working session.