Use Case

Automating DSCSA compliance for cold chain temperature tracking


Complying with strict mandates while maintaining temperature sensitive biologicals is a pervasive challenge in healthcare, manufacturing, and transportation and logistics. To resolve this challenge safely, the Zebra FX9600 Fixed RFID Reader, RFID portals, and Zebra Visual Indicators create a streamlined, compliant tracking process.

A healthcare logistics worker pulls cargo past a wall-mounted Zebra FX9600 fixed RFID reader automatically tracking shipments.

Strict mandates and cold chain tracking

Organisations must comply with strict DSCSA mandates to track, trace, and authenticate every drug. Simultaneously, they must maintain the safety and efficacy of temperature-sensitive biologicals. This challenge is currently managed through siloed, manual, and error-prone processes. Facilities suffer from manual data entry bottlenecks, disconnected IT systems, high risk of counterfeit drugs, and tedious manual temperature checks.

These manual processes lead to massive product waste when bulk shipments experience assumed temperature excursions. The financial losses and operational bottlenecks associated with these assumed excursions are significant. The high costs of discarding uncompromised units due to a lack of precise temperature data negatively impact the bottom line and overall efficiency.

The automated cold chain compliance solution

By using the Zebra FX9600 Fixed RFID Reader and RFID portals with Zebra Visual Indicators, facilities can automatically authenticate items at critical operational stages. This system meets DSCSA compliance without introducing bottlenecks inducing manual data entry. Organisations achieve seamless DSCSA compliance and prevent counterfeiting while dramatically reducing cold chain product waste. Moving from manual scans to automated data capture keeps high volume shipments moving safely through the supply chain.

Potential benefits

Transitioning from manual tracking to an automated system brings tangible and quantifiable outcomes. Implementing these solutions provides compliance, accelerates production, and significantly reduces the waste of sensitive medical products.

High volume production speed

allowing bulk shipments to move seamlessly without tracking delays

Eliminated manual scanning bottlenecks

by seamlessly tracking assets as they move through the facility

Reduced cold-chain product waste

by identifying and discarding only specific spoilt units rather than entire shipments

 

 

How the solution works

A logistics worker pulls pharmaceutical shipments past Zebra RFID portals at a warehouse doorway to capture serialization data.

Establish automated data capture at key choke points

Capturing data automatically at critical operational stages eliminates the bottleneck inducing manual data entry slowing down modern facilities. The Zebra FX9600 Fixed RFID Reader delivers exceptionally high read rates in tough environments to keep bulk shipments moving quickly. It automates tracking and authentication without slowing down high volume production speeds. This reader is uniquely suited for demanding logistics spaces that require continuous visibility into sensitive materials.

Implement comprehensive tracking at facility thresholds

Providing seamless transition tracking as goods move between zones requires specialised infrastructure designed for high traffic areas. RFID portals automatically capture tag data as pallets pass through without requiring workers to pause or manually scan items. They integrate easily into existing doorways to track sensitive biologicals precisely. By supporting high volume production speed directly at choke points, these portals keep materials flowing efficiently while continuously validating compliance requirements.

Perform targeted temperature inspections

Upon inbound receiving, if a general transit log flags a potential temperature excursion, workers perform a targeted inspection using Zebra Visual Indicators. They identify and discard only the specific spoilt units based on colour changes, safely retaining the insulated core of the shipment. This dramatically reduces cold chain product waste by providing clear visual alerts rather than discarding entire bulk shipments based on assumed excursions.

Securing the cold chain for the future

Investing in an automated tracking architecture protects both your bottom line and public health. Streamlining compliance operations lowers overhead costs while eliminating the expensive waste associated with counterfeit risks and unmonitored temperature excursions.

Let's discuss how Zebra's solution can work for you

Note:

Use case figures, savings estimates and images are illustrative only and may be derived from customer data, projections, or controlled testing. They do not represent guaranteed results, and actual outcomes will vary by application; customers should consult a Zebra sales representative to evaluate their specific environment.