GSK

Introduction

The demand for temperature-controlled pharmaceutical shipments is increasing and sea freight has emerged as a viable transportation mode for cold chain logistics. When handling pharmaceuticals and specialty medicines that require strict temperature control between 2°C and 8°C, reefer containers provide a cost-effective, environmentally friendly and robust solution.

Advantages of Reefer Containers in Cold Chain Logistics

Using reefer containers for sea freight offers multiple benefits, including cost savings and reduced carbon emissions compared to air freight. In addition to this, it provides a reliable method of maintaining temperature control throughout the transportation process. However, the complexity of sea freight logistics requires coordination among multiple stakeholders, including warehouses, road transport carriers, port authorities, reefer maintenance teams and vessel crews. The end-to-end transport of a reefer container via sea-freight can be visualized below:

Key Considerations for Cold Chain Shipments via Sea Freight

1. Qualification of Temperature-Controlled Reefers

To ensure reefer containers maintain the required temperature range across various climatic conditions, a thorough qualification process is necessary within the pharma environment. This includes:

Thermal Mapping: Assessing reefer performance in different climatic zones using temperature sensors within the cargo load to assess risk areas and temperature homogeneity within the reefer container. Equipment Types: Common reefer brands that needs to be within the qualification scope include Carrier (Primeline/ Thinline), Thermo King, Daikin and Star Cool that form majority of the equipment available in the fleet.

Qualification Testing: Conducting yard or simulated chamber tests to evaluate stress factors and power failure scenarios, determining how long the reefer can maintain its internal temperature without an external power source.

2. Continuous Power Supply & Temperature Maintenance

Temperature-controlled reefers need a constant power supply to regulate internal temperatures as per the set-point. During sea-freight, they are unplugged and reconnected at various journey nodes (e.g., road, port, vessel). This unplugged period is critical, as reefers struggle to maintain temperatures for long, especially in extreme climates. In winter, temperatures may drop below -15°C, and in summer, they can exceed 45°C. Without power, reefers have limited ability to maintain a strict 2°C to 8°C range. Ensuring continuous power supply or mitigation strategies is crucial to preserving cargo integrity in challenging environmental conditions.

During transportation, the reefer must be:

• Plugged into a power source at sea-ports (i.e. reefer dock) and on sea vessels

• Connected to a Generator Set (Gen-Set) during road (on land) transportation.

3. Sea-Port Assessments and Handling Risks

Pharmaceutical companies must assess sea-ports to mitigate risks associated with reefer container handling. Critical evaluations include:

• Customs clearance time and inspection if cargo needs to be opened

• Potential demurrage risks and associated cost if additional clearance time is required at ports or bonded warehouses.

• Insurance threshold value could be exceeded based on the commercial value of the cargo

• Cold chain risk assessments for bonded warehouse storage options.

• Commitments from sea carriers and port authorities to ensure timely re-connection to power sources at ports and on vessels. The maximum time reefers would be un-plugged must be evaluated based on the feedback/assessment and understand the potential risk. Additional thermal protection measures could be included such as applying thermal blankets to delay potential temperature excursions during plug-off period.

4. Reefer Pre-Requisites & Maintenance

The age and condition of reefer containers are crucial for pharmaceutical shipments. Strict guidelines include:

Age Restriction: Some pharmaceutical companies enforce limits on reefer container age.

Pre-Trip Inspections (PTI): Reefer maintenance teams must conduct full pre-trip inspections before each shipment, ensuring:

• Reefer structural integrity .Functionality of electronic and mechanical components

• Cleanliness and dryness of the container interior

• Routine Reefer Servicing: Regular servicing of cooling systems, insulation and air circulation mechanisms to ensure reliability

Reefer Calibration and Service: Reefers are typically equipped with four temperature sensors to monitor supply and return air temperatures. Reefer temperature control typically includes:

• Automatic probe diagnostics to detect sensor discrepancies.

• Periodic sensor checks and replacements if readings deviate from acceptable ranges.

• Use of backup sensors to mitigate risks associated with sensor malfunctions.

5. Preparation of Reefers for Pharmaceutical Shipments

To ensure cargo integrity, pharmaceutical shipments in reefer containers must follow specific preparation processes:

• Use of air-bags and cord-straps to prevent pallet movement and product damage. •Floor mats to facilitate proper air circulation around the container.

• Temperature settings with a set-point of +5°C for optimal stability for +2°C to +8°C shipments.

• De-humidification control set to "OFF" to prevent temperature fluctuations.

• Placement of independent temperature data loggers at critical points (e.g. front and back of the container) to monitor temperature conditions.

6. Real-Time Temperature Monitoring & Risk Mitigation

Monitoring temperature deviations is critical for ensuring compliance with Good Distribution Practices (GDP). Key monitoring practices include:

• Real-time temperature tracking devices in the cargo load that provide alerts if temperature deviations occur.

• Routine checks by vessel crew operators, usually conducted twice daily during sea voyage.

• Live monitoring capabilities offered by some sea carriers, allowing operators to detect temperature anomalies and perform minor repairs on board.

• Port-side monitoring at regular intervals to verify reefer temperature compliance.

• Emergency response plans to address power failures or reefer malfunctions in transit.

7. Regulatory Compliance & Documentation

Pharmaceutical shipments via sea freight must adhere to stringent regulatory guidelines, including:

• Good Distribution Practices (GDP) ensuring temperature integrity is maintained.

• Customs and import/export regulations that vary by country.

• Documented temperature records to provide traceability and ensure compliance.

• Standard operating procedures (SOPs) for handling, monitoring, and responding to temperature excursions.

• Audit of Logistics Service Providers

• Service Level Agreements and/or Quality Agreements with Logistics Service Provider to ensure all expectations and requirements are clearly defined

8. Sustainability Benefits of Sea Freight Cold Chain

Using sea freight for pharmaceutical cold chain shipments presents significant environmental benefits:

• Reduced Carbon Footprint: Sea freight generates significantly lower CO₂ emissions than air freight.

• Energy-Efficient Reefer Technologies: Advancements in reefer insulation and cooling systems help reduce energy consumption.

• Sustainable Packaging Solutions: Use of sea-freight will dictate lower consumption of cold chain packaging materials that are used for air-freight, thus reducing environmental impact.

Conclusion

Sea freight with temperature-controlled reefer containers offers a cost-effective, sustainable option for pharmaceutical shipments. Meticulous planning, strict qualification, continuous power, risk assessments, and real-time monitoring ensure product integrity, optimizing costs and reducing environmental impact while ensuring safe transport of temperaturesensitive products.