Cold Chain Logistics Monitoring 🌡️ ELPRO

Cold Chain 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:

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

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.

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.

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.

liberoMANAGER for Boehringer Ingelheim

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

Practical Guide: Cold Chain Logistics Choices

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

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

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

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

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

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.

Cold Chain Logistics