Transport Validation Helps Ensure Drug Stability for Ocean Container Shipments
Situation & Challenges
A leading pharmaceutical manufacturer needed assurance it could transport insulin via ocean containers and preserve the product’s stability, quality, and integrity. The company wanted to pilot pallet shipments of this temperature-sensitive product to South Asia using ocean freight. The pharmaceutical manufacturer contracted with Modality Solutions to conduct a risk assessment, facilitate performance qualification of the selected shipper, and develop a transport validation master plan to optimize their cold chain transport for this and other temperature-sensitive drug products.
Why BlueRidge Life Sciences
With industry-leading expertise in biopharmaceutical cold chain engineering and a proven track record of optimizing global cold chains for temperature-sensitive drugs, BlueRidge Life Sciences (BRLS) was the ideal partner for this engagement. BRLS engineers are highly experienced in conducting drug transport risk assessments and creating transport validation master plans for a wide range of therapeutics. The BRLS team could leverage its deep understanding of cold chain risks while shipping to a hot and humid climate (ICH Zone IV) using ocean freight. Our transport validation planning expertise would enable this pharmaceutical manufacturer to ship its insulin product with confidence.
Project Objectives
This engagement involved combining critical data and specifications essential for container qualification and transport validation, qualifying the ISO shipping container, and developing a master plan to mitigate potential risks.
BlueRidge Life Sciences was tasked with:
Conducting a risk assessment
Compiling a technical assessment of the manufacturer’s qualification process, testing data, and specifications to select the appropriately classed ISO container
Preparing a technical assessment of shipping temperature-sensitive drugs via ocean using protocols, data
packages, and shipping validation reports
Creating a validation master plan based on identified risks and GDP/GMP regulations
Drafting a performance qualification protocol to test the chosen container
Overseeing the execution of the performance qualification
Reporting on qualification results.
The Solution
BlueRidge Life Sciences drew on its experience providing transport validation for controlled temperature drugs to assess the process, identify and mitigate risks, and help quantify container performance.
The Engineering Consulting Solutions project included these critical activities and deliverables:
Created process maps for ocean shipping, monitoring, and control
Conducted a risk assessment to identify and prioritize risks associated with ocean transport and developed risk mitigation strategies
Compiled a technical assessment of vendor equipment testing data and specifications
Reviewed the technical assessment to determine if ocean transport of insulin was viable
Oversaw execution of a third-party ocean transport performance qualification for temperature-sensitive drugs
Developed a product testing assessment and strategy to confirm drug chemical and physical stability in transit
Created a validation master plan detailing the transportation approach, risks, vendor data, and expected results
The Results
BRLS conducted a comprehensive risk assessment and transport validation by evaluating equipment operational qualification data, test data, and vendor specifications. BRLS oversaw the successful qualification of the selected ISO container. They validated the ocean transport process for insulin and other temperature-sensitive drugs, enabling this pharmaceutical manufacturer to ship its products on the ocean confidently.
