Optimal Temperature Ranges for Pharma and Vaccines Transportation

Michael Zach, SVP at Flughafen Wien AG, and David Canavan, COO of Challenge Group, share their perspectives on the vital role temperature plays in the safe storage and transportation of pharmaceuticals, especially vaccines and medicines.

By Ayesha Rashid

In the pharmaceutical world, temperature is impacting every stage of drug development and production. And when it comes to transporting them domestically or across continents, having the right temperature is equally important.

Pharmaceutical and life sciences products, which include vaccines and medicines, are highly sensitive to temperature fluctuations. Maintaining strict temperature control during storage and transportation is essential to prevent degradation and loss of efficacy.

Temperature-controlled supply chains are necessary to ensure that products reach their destination in optimal condition. This involves using specialized packaging, transportation vehicles, and monitoring systems.

In an interview with Air Cargo Update, Michael Zach, Senior Vice President of Ground Handling & Cargo Operations at Flughafen Wien AG, and David Canavan, Chief Operating Officer of Challenge Group, shared their insights on the critical role of temperature control in pharma and vaccine transportation.

They emphasized how even slight temperature fluctuations can affect the potency and stability of these sensitive products, making careful monitoring essential.

Pharmaceutical/Vaccines Logistics
Pharmaceutical logistics’ involve the procurement, storage, transportation and distribution of medications and related healthcare products while ensuring their integrity, safety and regulatory compliance.

Additionally, it also addresses challenges, such as cold chain management, timely delivery, inventory control, and adherence to Good Distribution Practices (GDP).

The global pharmaceutical logistics market size was valued at USD $92.18 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 9.3% from 2024 to 2030.

The short-term impact of the COVID-19 pandemic on the market is a crucial factor for the fast-paced growth of pharmaceutical logistics.

As such, the trade of conventional medicines is increasing from country-to-country (Grand View Research).

According to Mordor Intelligence, the Vaccine Logistics Market size is estimated at USD 3.13 billion in 2024, and is expected to reach USD 4.04 billion by 2029, growing at a CAGR of 5.20% during the forecast period (2024-2029).

The wide variety of new vaccines and immunization schedules and service delivery strategies, the expanding target population, the increased cold-chain infrastructure requirements, and insufficient funding are some of the new realities that may further impact the vaccine transportation market.

Due to the enormous rise in demand for vaccine storage services brought on by the COVID-19 epidemic, pharmaceutical companies focused their efforts on creating cold chain logistics.

Therefore, the vaccine cold chain logistics market will probably see new growth prospects in the coming years due to the increasing R&D initiatives.

Regulatory Guidelines and Standards
To safely transport pharmaceuticals and vaccines, it’s crucial to follow regulatory guidelines.

Key organizations like the World Health Organization (WHO), International Air Transport Association (IATA), and U.S. Food and Drug Administration (FDA) set these rules.

For example, the WHO’s guidelines focus on how vaccines should be packaged, stored, and handled, with strict temperature monitoring.

Transporting pharmaceuticals via air faces challenges and offers opportunities in the cold chain.

The pharmaceutical industry depends on air transport for speed and reliability.

However, aviation often struggles to meet the high standards required, like expertise, infrastructure, and regulation compliance.

To address this, IATA created CEIV Pharma, a certification that helps the air cargo industry improve safety, security, and efficiency in pharmaceutical handling.

It ensures consistent, high-quality standards across the supply chain.

The FDA also provides guidance on maintaining proper temperature during transportation to protect product quality.

Challenge Group’s COO, David Canavan said, “We adhere to the IATA CEIV Pharma regulations, which provide a comprehensive framework for ensuring the safe and secure transportation of high-value pharmaceuticals and vaccines. Additionally, we implement more stringent procedures as required by specific customers.

“These protocols include rigorous temperature control, advanced tracking systems, specialized packaging, and continuous monitoring throughout the entire logistics chain. Our commitment to these standards ensures that we maintain the highest levels of safety, security, and compliance in handling sensitive pharmaceutical shipments.”

Flughafen Wien AG’s SVP Michael Zach said, “Vienna Airport follows all relevant international guidelines from Good Distribution Practice (GDP), IATA, and airlines to ensure the safe and secure handling of high-value pharmaceuticals and vaccines. Vienna Airport’s Standard Operational Procedures (SOP) has been made based on these guidelines, plus each customers’ requirements. These SOPs are regularly updated based on feedback and new regulatory requirements.

“To maintain high standards, Vienna Airport conducts regular audits and compliance checks of its pharma handling processes. These checks ensure that all protocols are followed, and that the airport remains compliant with international regulations and standards.”

Pharma and Vaccine Temperatures

Product Type	Temperature Range
Vaccines	+2°C to +8°C
Biologics	+2°C to +25°C
Cold Chain Products	-20°C to -50°C
Ambient Products	+15°C to +30°C

 

Temperature Protocol	Impact on Product Quality
Refrigeration (2°C – 8°C)	Maintenance of vaccine potency and stability.
Cryogenic storage (-20°C to -80°C)	Preservation of sensitive biological materials.
Ambient storage (15°C – 30°C)	Optimal conditions for certain pharmaceuticals and vaccines.

Canavan states, “We transport a wide range of pharmaceuticals and vaccines that require temperature control within a range of -20°C to +25°C.

“On average, 70% to 80% of pharmaceuticals and vaccines which we carry require transportation within a temperature range of +2°C to +25°C. For context, we utilized approximately 400 special containers for these shipments in the first half of this year, underscoring our capability to manage and maintain the required temperature ranges effectively.”

With over 40 years of experience in the industry, Challenge Group has developed the expertise to handle these diverse products effectively.

Their specialized global team is well-versed in managing the unique requirements of these shipments, ensuring their integrity and safety throughout the transportation process.

Ensuring Cold Chain Integrity

Aspect	Impact on Product Integrity
Temperature fluctuations	Potential degradation or denaturation of active ingredients.
Inconsistent storage conditions	Variable product performance and reduced shelf life.
Uncontrolled shipping environments	Risk of contamination, spoilage, or damage during transport.

Canavan said, “We maintain the necessary temperature controls for temperature-sensitive pharmaceuticals and vaccines by utilizing dedicated pharma trucks for the first and last mile of transportation and delivery.

“Additionally, all pharma shipments are stored in specially designated temperature-controlled cool rooms with a 24/7 monitoring system at any of our facilities, ensuring consistent conditions. Inside the aircraft, we can set and monitor the temperature within a range of +2°C to +25°C, ensuring the integrity of the pharmaceuticals and vaccines throughout the entire journey.”

Zach explained, “The GDP-certified Vienna Airport Pharma Handling Center (VPHC) offers dedicated facilities for temperature-sensitive goods like pharmaceuticals and biotech products. It includes two large cooling warehouses: one for 2-8°C with 150 square meters, and another for 15-25°C with 1,600 square meters. A direct airside-to-landside connection ensures fast processes.

“We use mobile refrigeration equipment, such as cool trailers and thermos blankets, to safely transport goods between areas. With four cool trailers ranging from -20°C to +29°C, temperature control is maintained throughout. The VPHC also uses temperature sensors and CCTV for continuous monitoring.”

Challenges Faced
According to Challenge Group, airlines face key challenges in transporting high-value pharmaceuticals, including maintaining proper temperature, ensuring security, and managing communication effectively.

To tackle these, Challenge Group implements several measures:

• Temperature Control: Dedicated pharma trucks for first and last-mile transport, specialized temperature-controlled storage, and precise in-flight temperature settings ensure consistency throughout the journey.
• Security: High-security measures include sealed trucks, secure transit storage, minimizing tarmac time with last-minute loading, pre-conditioned aircraft, and prioritizing first unloading at the destination.
• Communication and Handling: Special handling instructions, continuous supervision, and clear communication at each step ensure quick response to any issues.

According to Flughafen Wien AG, handling and storing high-value pharmaceuticals at airports present several significant challenges, given the sensitive nature of these products.

These challenges range from maintaining strict temperature controls to ensuring security and regulatory compliance.

Zach further said that this kind of handling is ensured with their well-equipped warehouse (VPHC) and well-trained, dedicated pharma staff.

Pharma-Vaccine Handling Collaboration
All parties involved in the transportation of pharmaceuticals and vaccines must work together to ensure the integrity of these sensitive products.

This collaboration is necessary to maintaining the required temperature ranges during transportation, as it involves multiple stakeholders, including manufacturers, logistics providers, and regulatory bodies.

Canavan explained, “We collaborate closely with pharmaceutical companies and freight forwarders to ensure the safe handling and timely delivery of pharmaceuticals and vaccines by sharing all relevant information well in advance. This allows us to properly plan the booking, pick-up, delivery, handling instructions, storage, and loading.

“We also arrange for special equipment whenever needed to meet specific requirements. Additionally, we actively participate in major pharma events and conferences to stay updated on the latest technologies and best practices in the industry. This proactive approach ensures seamless coordination and adherence to the highest standards in the transportation of pharmaceutical products.”

According to Zach, “First of all, we set the procedure with each customer and direct and constant communication channels to act in real time base. Our customers appreciate the direct, customer-oriented and professional contact with our staff.”

Specialized Pharma Transport Gear
The Challenge Group uses a wide array of specialized equipment to transport pharmaceuticals and vaccines.

This includes various types of special containers sourced through agreements with leading industry manufacturers and suppliers.

“Our equipment portfolio features Envirotainer, and Challenge Handling in Liege is a certified recharging station. We also utilize Softbox, Tower, SkyCell, CSafe, and Va-Q-Tec containers along with thermal blankets. All these are designed to maintain the required temperature range between -20°C and +25°C, ensuring the safe and secure transport of temperature-sensitive pharmaceuticals and vaccines,” Canavan said.

Training for Pharma Logistics
Canavan notes that Challenge Group’s staff receive extensive training to handle high-value pharmaceuticals and vaccines.

This includes IATA CEIV Pharma certification and specialized training in handling, loading, dry ice management, build-up, and storage.

“Compliance with these protocols is ensured through continuous education, regular audits, and strict adherence to established procedures. This rigorous training and monitoring process ensures that the team is well-equipped to manage the complexities of transporting sensitive pharmaceutical shipments securely and efficiently on a global scale.”

Zach states, “Our staff receives the Pharma Standard Operational Procedures training, which is a four-week dual training course with classroom training and lots of practice in our proven buddy system, completed with a certificate upon successful completion of the exam.”

Theft and Tampering Prevention
To prevent theft or tampering during the transportation of high-value pharmaceuticals and vaccines, Challenge Group implements several measures:

• TAPA Certified Trucking: Utilizing trucks certified by the Transported Asset Protection Association (TAPA) ensures that the vehicles meet high-security standards designed to protect valuable cargo.
• Security During Loading and Unloading: Security protocols are in place during the loading and unloading processes to ensure that pharmaceuticals and vaccines are handled securely and that no unauthorized access occurs.
• Escorting to the Warehouse: The cargo is escorted from the point of departure to the warehouse and then to the cool room, providing an additional layer of security to safeguard against theft or tampering throughout the journey.
• CCTV Cameras in All Warehouses: Surveillance cameras are installed in all warehouses to monitor and record activities, ensuring that any suspicious behavior can be quickly identified and addressed.

Flughafen Wien AG’s Zach stated that access to the warehouse is restricted to authorized personnel only.

Additionally, CCTV has been installed in all VPHC areas.

Furthermore, they have implemented a “if you see something – say something” culture, which helps maintain professionalism and customer focus at the highest level.

Technological Breakthroughs

• Enhanced Temperature Control Technology: Challenge Group notes that advances in specialized equipment have significantly improved the ability to maintain precise temperature control during transit. This ensures that pharmaceuticals and vaccines are kept within their required temperature ranges, preserving their efficacy and safety.
• Advanced Deviation Monitoring: According to Challenge Group, new technologies in deviation monitoring allow for real-time tracking and reporting of any changes in conditions that could affect the cargo. This enables quick responses to any issues, minimizing potential impacts on the integrity of the shipments.
• Improved Power Supply Systems: Challenge Group highlights that innovations in power supply technology enhance the reliability of temperature-controlled systems, ensuring uninterrupted operation throughout the transportation process. This helps maintain consistent conditions and prevents any disruptions that could compromise the pharmaceuticals and vaccines.