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Standards and Sensors for Visibility in the Pharmaceutical Cold Chain

Fill the Blind Spots in Your Cold Chain

The pharmaceutical cold chain has seen rapid developments in sensor technologies. With a greater number of critical drug treatments requiring shipping and storing in uninterrupted cold conditions, from manufacture all the way to patient administration, full visibility into the product’s entire journey, including problematic events like temperature excursions, helps ensure product quality and patient safety. However, there are blind spots in the cold chain. A solution could be the implementation of compatible sensor configurations and standardized data-sharing processes.

Data-sharing processes and architecture, built on a foundation of existing GS1 Standards, are the connective tissue that holds the sensor network together.

The GS1 Standards that form the foundation for interoperable and optimized cold chain visibility include:

1. Identify: The Foundation of Traceability

  • Standardized product, location, and entity identifiers enable consistent and unambiguous data across the supply chain, supporting common understanding of the following traceability elements:
    • What: What needs to be traced?
    • Where: Where did the movements or events take place?
    • When: When did a movement or event that included the object occur?
    • Why: What happened? What was the business process that was happening at the time? Why was the object at that location at that time?

2. Capture: Landscape of Sensor Technologies

GS1 Standards are technology agnostic and can therefore be used in conjunction with many types of data carriers. This ensures that key cold chain identification data (product, location, entity, etc.) can be stored in the specific data carrier that best fits the relevant phase of the cold chain. Due to the complex nature of a product’s journey through the cold chain, there are a wide variety of sensors that could address different use cases that arise.

Six Sensors for Cold Chain Visibility

In this whitepaper, discover how different sensor technologies have been deployed in the cold supply chain:

  • RAIN RFID*
  • Active RFID
  • Bluetooth Low Energy (BLE)
  • Low-Power Wide Area Networks
  • Near-Field Communication (NFC)
  • Global Positioning System (GPS) and Temperature

While some of the sensor technologies discussed may not appear in current GS1 Standards implementation guidelines, they are increasing in prevalence in the cold chain ecosystem. Therefore, it is important to consider the various sensor technologies in achieving interoperability.

Creating a Sustainable Supply Chain

3. Share: EPC Information Services (EPCIS) and Core Business Vocabulary (CBV)

When it comes to cold chain management, the principal concern on supply chain leaders’ minds is whether their product has been kept within the permissible temperature throughout its journey. Cold storage facilities often advertise a variety of climate control parameters, not just frozen and refrigerated. Different products have different permissible temperature thresholds, and some products may accept short deviations permitted boundaries—but only for certain durations.

By defining product‑specific temperature parameters and business rules—and making this information available through the GS1 Global Data Synchronization Network™ (GS1 GDSN®) or via a web resource using GS1 Digital Link—trading partners can support automated cold chain exception management using EPCIS in combination with sensor‑enabled RFID technologies.

Building on the benefits established through standardized identification and data capture, the application of GS1 Standards in the data sharing layer can support the effective use of IoT‑generated data across trading partners. When this data is captured and shared consistently, it may be used to enable advanced analytics, including artificial intelligence–based analysis, to support timely and informed decision‑making.

Suggested FAQ Content

A cold chain is a temperature controlled, often refrigerated supply chain. Items are refrigerated from their origin to their final location; items can include perishables like food and ice cream. A cold chain also includes more critical items like medical supplies that can include organ transport or vaccines, the goal is to ensure public safety.

Maintaining temperature integrity, and the ability to track any temperature excursions, while reducing energy, waste, emissions and costs.

Sensor technologies in the cold supply chain include temperature and location monitoring devices that leverage technologies such as RFID, NFC, and GPS to capture and transmit data throughout a product’s journey. GS1 Standards do not enable the capture itself but support the standardized identification and sharing of that data across trading partners for end-to-end visibility.

One of the biggest challenges is visibility into the location, chain of custody, event level traceability, temperature data, as well as maintaining the integrity of the temperature throughout its journey in the supply chain.

Related Articles

Here are additional resources that might interest you.

Unlock Traceability, Inventory Management, and Sustainability

Unlock Traceability, Inventory Management, and Sustainability

Enabling visibility in your supply chain can help you address inefficiencies and react to disruptions.

Find out about Track and Trace in the Drug Supply Chain

Find out about Track and Trace in the Drug Supply Chain

Learn more about DSCSA compliance and get guidance for dispensers and suppliers.  

Case Study: Fresenius Kabi

Case Study: Fresenius Kabi

Read how Fresenius Kabi launched an ambitious program to tag vials of medication using RAIN RFID powered by GS1 Standards.

Are you ready for DSCSA Requirements?

Avoid disruption in your supply chain by learning how GS1 Standards can help you meet interoperability requirements.

GS1 Company Prefix Pricing
GS1 Company Prefix Pricing
Number of items needing a barcode/GTIN Initial fee Annual renewal fee
1 GS1 US GTIN $30 $0
10 $250 $50
100 $750 $150
1,000 $2,500 $500
10,000 $6,500 $1,300
100,000 $10,500 $2,100
GS1 Company Prefix including U.S. FDA NDC Labeler Code $2,100 $2,100