<img alt="" src="https://secure.perk0mean.com/184386.png" style="display:none;">

Cold Chain Monitoring
and Its Challenges

Trusted End-to-End Compliance – From Production to Final Destination

Cold Chain Monitoring
and Its Challenges

Trusted End-to-End Compliance – From Production to Final Destination

The term "cold chain" describes the technology, process or industry of distributing pharmaceutical products throughout various steps in the supply chain to the patient. Since the EU GDP Guideline has widened the scope, all pharmaceutical products carrying some sort of stability budget are considered temperature sensitive and are subject to monitoring. There is a wide field of different applications:

What is your Cold Chain Monitoring Application?

 

What is your Cold Chain Application?

 

Cold chain monitoring is complex and many different hardware and software options are often required to solve the various tasks associated with it. In this video we explain the various applications and how to navigate to the correct landing page for more details.

Qualification: Containers, Boxes, Networks, CEIV

 

Any piece of equipment used in a GDP environment to store or transport products must be qualified. This applies to containers, boxes, airplanes, trucks, vans, and even trade lanes. Qualification is the process of proving that a piece of equipment, room, trade lane or network fulfils the intended purpose. Compared to equipment and rooms, the qualification of an entire network is much more complex and requires significant paperwork.

Trans_AirplaneCargo_App_Quality

New

Transport/ Packaging Qualifications – Where are we?

Listen to recent 2020 feedback from industry groups ISTA and PDA on efforts to establish best practices for packaging qualification.

Watch Video Now

Generic Requirements for a Cold Chain Monitoring Solution

 

PDF Data Loggers & Indicators

Offline data loggers generating a PDF are still the most flexible and cost efficient way for many applications.

 

 

  • 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 Monitoring

Real-Time data loggers communicating via public LTE-M Network provide various process advantages.

 

 

  • 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

Cold Chain Database

Customized for all your different processes. Combine all available hardware options in the most powerful cold chain database.

 

  • 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

Ready to Get Started? Contact us today.

Complete the form below to tell us a little more about up upcoming project and we’ll have one of our GxP services professionals contact you to set up a project scoping call and gather all the details. We look forward to speaking with you soon.

 

Looking for other ELPRO solutions?

ECOLOG Connected Monitoring

ECOLOG Connected Monitoring Solutions

Scalable GxP-compliant environmental monitoring systems for warehouses, labs and cleanrooms – from simple to integrated enterprise solutions.

Explore ECOLOG

LIBERO Stability Monitoring

LIBERO Stability Monitoring Solutions

GxP-compliant cold chain monitoring for any temperature range with options ranging from simple pre-configured indicators to powerful database solutions.

Explore LIBERO

INDEPENDENT Monitoring for Rooms & Equipment

INDEPENDENT Monitoring Solutions for Rooms & Equipment

GxP-compliant temperature and temperature / humidity monitoring of rooms and systems – a simple and flexible solution that works offline and without power.

Explore INDEPENDENT

SERVICES GxP Compliant Consulting & Support

ProdFam_Services_norm_shop-1

Do you need help with qualification or maintenance of your systems, rooms or facilities? Find out more about the wide range of GMP services we offer.

Explore GxP Services