Cold Chain Temperature Monitoring in Logistics

Ensuring end-to-end pharma supply chain compliance and product stability, from production to patient.

Cold Chain Temperature Monitoring in Logistics

Ensuring end-to-end pharma supply chain compliance and product stability, from production to patient.

Cold chain temperature monitoring of medicines, vaccines, tissue samples, and advanced therapies in transit–from API storage or distribution all the way to the patient–is extremely complex. The COVID pandemic that disrupted supply chains in the pharmaceutical industry, highlighted the importance of a robust, Pharma, life science and healthcare logistics infrastructure to store and transport vaccines. However, there are numerous applications and some are very unique and sensitive to time, temperature, humidity, shock, light and other extraneous factors. Proper temperature and humidity monitoring throughout the pharma logistics journey is critical. It is essential to maintain product stability, expedite faster release times, and ultimately, ensure a safe temperature range has been maintained to deliver the best quality medication to patients.  

 

Cold Chain Logistics and Temperature Monitoring Applications

 

All pharmaceutical products, including cell and gene therapies (CGTs) carry a stability budget. Therefore, they are considered temperature sensitive and subject to monitoring according to GDP regulations. The chart below illustrates several examples for pharma logistics, many of which involve warehouse industry personnel responsible for temperature control. At every step along the supply chain the temperature must be monitored. This could include integration into the packaging, carriers, and even storage facilities of pharmaceutical products, CGTs, and vaccines.

 

What is cold chain distribution in a supply chain?

 

There are many complex temperature monitoring scenarios involved when considering cold chain distribution in a supply chain. Several temperature-controlled scenarios for global delivery may include the following data loggers or monitoring devices:

 

  1. One way with product (single-use)
  2. Multi-step cold chain depots (multi-use)
  3. One way on product and cold room storage (single-use)
  4. End-to-End on product (box-level temperature monitoring indicators)
  5. Sample collection (box-level temperature monitoring indicators)
  6. One way with product and return (single-use or electronic temperature indicators)
  7. Continuous on mobile equipment (real-time on containers and/or transport vehicles)

What are Supply Chain Qualification Requirements?

 

For cold chain products and equipment used in transit, anything used in a GDP or GMP environment to store or transport products must be qualified. This applies to containers, cold boxes, airplanes, truck and vans fleets, and even trade lanes. Qualification is the process of proving that a piece of equipment, a room, a shipping lane, or even an entire network fulfils an intended purpose. Compared to qualifying equipment such as cryogenic shippers or freezers, and rooms, the qualification of an entire network is much more complex and requires significant analysis and process documentation.

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New

7 Reasons Why Cold Chain Monitoring is a Big Deal

There are 7 major aspects of the cold chain where monitoring is imperative for success.

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A Guide to GDP and Temperature Monitoring

Download a summary of everything you need to know about GDP guidelines as they relate to your temperature monitoring.

DOWNLOAD

LIBERO Cloud for Boehringer Ingelheim

Case study about the implementation of a uniform GDP-compliant in-transit temperature monitoring of complex mixed loads shipments.

DOWNLOAD

Practical Guide: Cold Chain Logistics Choices

Learn how the choice of transportation mode & equipment affect products, & how to best handle temperature excursions & subsequent CAPAs.

DOWNLOAD

ELPRO Saves You Time and Money  - Let Our Technicians Prep Your Fleet

of Cryo Shippers for Compliant Monitoring

 

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Rely on ELPRO experts to install and calibrate temperature monitoring kits to ISO 9001 quality standards on your new or used cryo containers. Our lab technicians have experience installing kits on all leading brands of cryo containers. The service includes:

  • Quality inspection and cleaning of cryo shipper lids and parts
  • Temperature data logger (sold separately-configured to your exact specifications)
  • Reliable high-quality external sensor/probe with connector
  • Secure stainless steel mounting bracket
  • 2-point NIST calibration certificate
  • Guaranteed 100% compliance
  • Optional calibration to your exact specifications

 

Cryo Kit Installation Request Form

 

Mail-In Temp Monitoring Kit Installation Service:
New or Used Cryo Shippers and Containers. (We Install on Them All.)

 

 

 

How it Works

 

1. Contact your ELPRO Sales professional to receive a quote and place your order. 

 

 

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2. Submit the completed RMA form along with your shipment (your cryo lid, etc.) to one of our global calibration labs.

 

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3. Submit your purchase order for processing.

 

 

 

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ELPRO Cold Chain Monitoring Solutions for Products in Transit

 

PDF Data Loggers and Indicators for Cold Chain Logistics

ELPRO LIBERO devices generating PDF reports are still the most flexible and cost efficient way to monitor a pharmaceutical shipment for your company.

 

 

 

 

  • Single-use PDF Data Loggers
  • Multi-use PDF/Bluetooth® Data Loggers
  • Electronic Indicators
  • GAMP5 compliant
  • FDA CFR 21 Part 11 compliant
  • Alarming on display & PDF
  • Manual read-out
  • PDF report
  • IATA compliant batteries
  • Free calibration certificate
Learn more

Real-time Temperature Monitoring During Shipment and Storage

ELPRO LIBERO Gx devices track temperature-controlled shipments in real time communicate via public mobile IoT networks. They provide best-in-class cold supply chain management in single and multi-use versions for trucks, trains, ships or planes, directly in product packaging or for cold temperature containers.

 

 

  • Single-use Real-time Data Loggers
  • Multi-use Real-time Data Loggers
  • Data Loggers for Containers & Trucks
  • GAMP5 compliant
  • FDA CFR 21 Part 11 compliant
  • 24/7 alarming via email & SMS
  • Automated read-out
  • Autoamted archiving & reporting
  • IATA compliant batteries
  • Free calibration certificate, Re-Calibration options
More about LIBERO Gx

ELPRO Cold Chain Database for Superior Pharma Logistics Temperature Management

Superior pharmaceutical logistics and supply chain management is at your fingertips with the liberoMANAGER solution. Track shipments in real-time, manage temperature data and assess excursions, automate notification processes, and visualize everything in one dashboard. liberoMANAGER is GAMP5 validated and CFR 21 Part 11 compliant.  

 

  • Single-use Data Loggers
  • Multi-use Data Loggers
  • Electronic Indicators
  • GAMP5 compliant
  • FDA CFR21 Part 11 compliant
  • Alarming via email
  • Manual/Automated read-out
  • Automated archiving & reporting
  • IATA compliant batteries
  • Free calibration certificate
Learn more

Real-Time IoT Data Loggers for Cold Chain Transport

 

Cold chain management in life science logistics is complex. However, with real-time IOT solutions, operations and cold chain logistics freight managers can be assured of end-to-end-supply chain visibility and react faster to temperature excursions during transportation. Whether products in transit are in cold boxes, temporarily stored in warehouse refrigeration rooms, or being held in a pharmacy for COVID-19 vaccine distribution, ELPRO LIBERO Gx data loggers document and prove the safety of the medication and vaccines in a refrigerator or freezer application.

 

The Global Pharma, Healthcare, Life Sciences and Biologics Logistics Market

 

The pipeline for advanced therapies (cell and gene) and biologics is large. Most of these medical treatments require white glove ultra-low cold storage and transport because they are highly personalized. One mistake in the freezing or transport of these therapies could mean life or death to the patient. The global growth potential for this new specialized healthcare is exponential. The adaptation of new technology to control temperature sensitive shipments and the transport and storage of these personalized medicines is critical. The COVID-19 pandemic accelerated the development of new worldwide ultra-low temperature management infrastructure. Warehouse facilities, storage depots and and freezer farms around the globe have grown as a result. Due to the highly-sensitive nature of these therapies, especially during transportation, there is demand for highly reliable temperature monitoring monitoring and real time solutions offering end-to-end supply visibility to shipments.