January 27, 2021

3 Cold Chain Challenges - Are You Prepared?

Cinta Burgos
3 Cold Chain Challenges - Are You Prepared? Teaser

Vaccine Administration - From Discovery to DeliveryTM


Vaccine administration is a key step in bringing the pandemic to an end. Seamless cold chain handling is vital to ensure the delivery of the COVID-19 vaccine from start to finish. 

Unlike most supply chains, GMP-based cold chain custody poses a unique set of challenges that require thorough planning and preparation. 

It is critical to maintain the temperature range of GMP products, including vaccines, so their integrity is not compromised. Distribution of medicinal products and vaccines is important in today’s global economy.  Temperature changes or lack of control could have dire consequences on patient safety and product efficacy. According to Fisher Clinical Services in their E-book, Cold Chain Qualifications, each year millions of dollars worth of vaccines are compromised due to improper storage and distribution. Manufacturers cannot afford these losses—neither can their customers and patients.

 

Understanding cold chain challenges is the first step in running a seamless operation and protecting your products.

  
 

#1 Knowing GMP-Based Cold Chain Regulations 

Global and economic events can have a huge impact on regulation changes. Staying up to date with regulations changes is extremely important to ensure the product is safe. Furthermore, it’s imperative to avoid unnecessary inspections and delays. Having a strong understanding of cold chain guidance from global regulatory bodies  is crucial to your overall operation.  

 

Are you ready and in-control with the following:

  • Storage and handling requirements 

  • Temperature recording requirements

  • Responsibilities for creating/maintaining reports

  • Distribution procedures 

 

Is your cold-chain storage compliant to International Organization for Standardization (ISO) 17025 “General Requirements for the Competence of Testing and Calibration Laboratories” and your measuring devices National Institute of Standards and Technology (NIST) Traceable? 

Solution: How Azzur Helps You Stay Up To Date

Knowing what questions to ask and how to take a risk-based approach can greatly benefit your operation by allowing you to  get up and running quickly and compliantly. Azzur works hand-in-hand with you during this planning stage so you have full understanding of qualifications and regulations.  

We keep you up to date with the latest regulations in GMP levels, NIST traceability, ISO 17025 compliance, and calibrations so your cold chain distribution and storage runs smoothly and is in compliance. 

 


#2 Having The Right Equipment 

The foundation of cold chain compliance is the preservation of temperature-sensitive products. Maintaining these temperatures  comes down to having the right equipment and preparing for possible break downs/malfunctions. Whether it is a power outage, coolant failure, or poor temperature circulation, these interruptions can have a huge affect on your cold chain distribution. Always be sure to keep in mind these key factors: 

  • Do you have enough fuel for your powdered cooling system?

  • What kind of coolant are you using and do you have a large enough supply?

  • Do you have resources for spare parts?

  • Do you have back-up energy to keep your equipment running?

  • Is your monitoring system working properly? 

Solution: Temperature Mapping and equipment qualification

Determining and understanding cold and hot spots in the planned equipment is important to know when planning for cold storage. Azzur Group technicians can temperature map the planned equipment for both storage and distribution. If a product is to be stored for a long time, then the above items can be addressed during an equipment qualification.

Azzur Group can be your greatest resource for temperature mapping equipment to keep your operation running smoothly. Some of this equipment includes:

  • Kaye Validator AVS

  • Sensitech TempTales

  • Vaisala Veriteq Data Loggers

  
 

#3 Distribution/Delivery Risks

The process of distribution involves two activities: transportation and storage. In cold chain management, the logistics of storing your product is much simpler than transporting it. Although transporting your products is just a mobile form of storage, a lot more variables are involved and the risk of equipment failure is amplified. 

 

A few factors that are at risk: 

  • Packaging Failure 

  • Hardware Failure 

  • Vehicle Breakdowns 

  • Lack of Equipment

  • Security Risks 

 

Solution: Temperature Mapping Training & Pre-Qualified Shippers

With products and vaccines at potential risk, most manufacturers turn to pre-qualified shippers to reduce these transportation risks. Through proper testing and qualifications, you can better prepare your operation and staff knowing the different variables at play. With proper planning, you can have the confidence that your distribution will uphold GMP-cold chain standards. 

 

Azzur’s hands-on approach can increase your team’s capabilities and reduce human error in distribution and storage. With proactive temperature mapping training, your team will be able to take on any new challenges. 

  
 

Getting started on the right foot makes a massive difference. Formulating a plan of action that outlines the logistics and potential threats will greatly reduce future problems with your operation. And, the impact of these decisions go far beyond your bottom line, as getting these life-changing innovations to the masses will change the course of our fight against disease.

 

Azzur meets you right at any stage of your cold chain journey; making sure you keep you cool from point A to point B. 

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Author

Cinta Burgos

Cinta Burgos is the Vice President of Consulting Services for Azzur Group. She has worked in various positions in research engineering, validation engineering, and quality assurance. Prior to joining Azzur Group, Cinta was an independent consultant supporting large global companies, as well as small start-ups. Prior to entering the life science industry, Cinta was a microbiology laboratory researcher. She holds a BS in BioPhysics from UC San Diego, has completed graduate student level work in Mechanical Engineering, was an adjunct faculty member of Tufts University Veterinary School teaching a masters level course in Good Laboratory Practice, and is currently on the Board of Directors of ASQ Medical Device Division and an active member of Society of Women Engineers.