How do you incorporate new technologies and innovations in your cold chain validation?

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Cold chain validation is a critical process for ensuring the quality, safety and efficacy of temperature-sensitive pharmaceutical products. It involves verifying that the storage and transportation conditions of the products are maintained within the specified range throughout the supply chain. However, cold chain validation is not a one-time activity, but a continuous improvement process that requires adapting to new technologies and innovations. In this article, you will learn how to incorporate new technologies and innovations in your cold chain validation, and what benefits they can bring to your business.

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1 Why innovate your cold chain validation?

Innovation is not only about adopting new tools and methods, but also about finding new ways to solve problems, optimize processes and enhance performance. By innovating your cold chain validation, you can reduce the risk of product degradation, spoilage and recalls due to temperature excursions or deviations. It can also improve the accuracy and reliability of your validation data and documentation, while saving time, money and resources by streamlining your validation activities and minimizing human errors and interventions. Moreover, it can help you enhance compliance with Good Distribution Practice (GDP) and other regulatory requirements and standards, as well as gain a competitive edge and reputation in the market by demonstrating your commitment to quality and innovation.

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George DeSilva

Validation Engineer | Quality Engineer | Program Manager
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Continuous monitoring of a warehouse space is a great example of innovation. Temperature mapping a large warehouse is a costly endeavor. CONT monitoring involves seasonal temperature mapping to determine the warm zones and the cool zones. Once identified, enough temperature (and RH if it applies) sensors are installed and connected the Environmental Monitoring System / Critical Alarm Monitoring System (to handle day in - day out TEMP or RH excursions as per the company's QMS). At the end of each season, the controlled state of the warehouse environment is assessed, including all TEMP (and RH, if applicable) excursions, corrective actions, preventative actions on the HVAC equipment, any shelving, building or HVAC changes.

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2 How to assess new technologies and innovations?

Before incorporating any new technology or innovation into your cold chain validation, you should assess its suitability, feasibility, and value for your specific needs and objectives. Ask yourself what problem or challenge you are trying to solve or address with the new technology or innovation. Consider how the new technology or innovation fits into your existing validation strategy, plan, and protocol. Additionally, think about the technical, operational, and regulatory requirements and implications of the new technology or innovation. Furthermore, consider how you will measure and evaluate the performance and effectiveness of the new technology or innovation. Finally, consider the costs, benefits, and risks of the new technology or innovation.

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George DeSilva

Validation Engineer | Quality Engineer | Program Manager
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This article is spot on: You must (honestly) evaluate suitability, feasibility and value when it comes to new innovations. Looking at the periodic TEMP mapping of 2 - 8 C ENV rooms (above and beyond the existing ENV Monitoring alarm / alert system) it was determined that each periodic TEMP mapping cost approximately $1800 (every 3 years). If CONT TEMP mapping was deployed, just the CAL costs for the sensors alone would be over $800 per year (using 8 sensors per room), or >$2400 every three years. And the costs associated with the periodic EVALs of the data, and replacing damaged equipment was unaccounted for. Unlike CONT TEMP mapping of warehouse areas, CONT TEMP mapping of ENV rooms (using this methodology) did not appear to be value added

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3 What are some examples of new technologies and innovations?

There are many new technologies and innovations that can help enhance your cold chain validation, depending on your specific needs and objectives. Smart sensors and devices can monitor and record temperature, humidity, location, and other parameters in real-time, transmitting the data wirelessly to a cloud or mobile app. Data analytics and AI can process the data collected by the sensors and provide insights, alerts, and recommendations. Blockchain and digital ledger technology can provide a secure, transparent, and traceable record of your cold chain validation data and documentation. Virtual reality and augmented reality can simulate and visualize scenarios and results, providing interactive training for staff.

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4 How to implement new technologies and innovations?

Once you have assessed and selected the new technologies and innovations that suit your needs and objectives, it is necessary to implement them in your cold chain validation in a systematic and effective way. To do this, you must define the scope, goals and criteria for the implementation of the new technologies and innovations. Additionally, develop a detailed implementation plan that outlines the roles, responsibilities, timelines, resources, procedures and expected outcomes of the implementation. It is also important to conduct a pilot test or trial run of the new technologies and innovations on a small scale or a representative sample of your products. Collect feedback and data from this test to evaluate the performance and effectiveness of these technologies. Following the pilot test or trial run, review and adjust your implementation plan based on the results and lessons learned from it. Address any issues or gaps that arose from the test. Finally, roll out the new technologies and innovations on a larger scale or across your entire supply chain. Monitor and measure their impact and value for your cold chain validation.

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5 How to maintain and improve your cold chain validation?

The implementation of new technologies and innovations is merely the beginning of your cold chain validation process. It is important to maintain and improve your cold chain validation by regularly reviewing and updating your validation strategy, plan and protocol, as well as conducting periodic revalidation or verification activities. Additionally, it is beneficial to seek feedback and input from staff, customers, suppliers, regulators and other stakeholders on your cold chain validation. It is also important to stay informed of the latest trends, developments and best practices in cold chain validation, exploring new opportunities for learning and collaboration.

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Sarantis Kosmas

Business Development Director @ Strategnos | Master's in Supply Chain Management
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There must be a clear strategy and categorization of what needs to be qualified and validated. This should be defined in the Validation Master Plan. The reason this is so important the complexity that may exist within the supply chain, including various temperature ranges, different packaging systems, various vehicles sizes and types and the use of 3rd party logistics services providers. Across these various elements it is necessary to develop a validation strategy that works from the ground up. That is qualifying the various independent elements first and then validating the process across those qualified objects.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Sarantis Kosmas

Business Development Director @ Strategnos | Master's in Supply Chain Management
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Implementing new technologies in cold chain validation requires that those technologies be validated themselves prior to use. In order to do so in a cost and time effective manner it is a good idea to spend some time testing these technologies in simulated, non critical, non formal manner first. The objective here is to determine the implementing the technology is actual usefull I'm the first case. Given the significant time investment of validating and updating documentation it is best to verify the the benifit before actual implementation.

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How do you incorporate new technologies and innovations in your cold chain validation?

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1 Why innovate your cold chain validation?

2 How to assess new technologies and innovations?

3 What are some examples of new technologies and innovations?

4 How to implement new technologies and innovations?

5 How to maintain and improve your cold chain validation?

6 Here’s what else to consider

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