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Protecting sensitive biopharmaceuticals in transit

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“Pharmaceutical manufacturers count on refrigerated fleet operators and shippers to follow good distribution practices [GDPs] to ensure regulatory compliance and protect the safety, integrity and efficacy of their high-value products,” said Gayatri Abbott, director, Smart Products and Telematics, for Thermo King.

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For most medical and biological products, the GDP guidelines require a temperature-controlled environment for all stages of manufacturing, shipping and storage. By some estimates, as many as 70% of products require some type of controlled environment, including those that need to be maintained at a consistent “room temperature.” According to the Biopharma Cold Chain Sourcebook, operators can expect to see a 37% spike in temperature-sensitive shipments over the next five years.

No wonder leading operators are equipping their fleets with integrated asset management systems. These systems protect shipments by establishing critical controls at all points in the supply chain.

“For example,” Abbott notes, “the TracKing asset management solution by Thermo King, a global leader in transport refrigeration and a business unit of Ingersoll Rand, uses a web-based telematics system embedded in the refrigeration unit control system to monitor temperatures, door openings and fuel levels; change set points and other control parameters; change operating modes; and respond to alarms using any computer, tablet or smart phone connected to an operators’ existing secure network.”

With the ability to create, modify, maintain and transmit records, the system supports manufacturers in their efforts to comply with the U.S. Food and Drug Administration electronic records/electronic signatures guidelines (Title CFR Part 11), which require them to create and retain comprehensive shipment records.

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The system is compatible with the shipper bill of lading systems so actual trailer temperature can be maintained within a range of the desired cargo temperature throughout the journey, both for single-product shipments and for those with a mixture of products requiring different temperature set points.

Abbot adds, “As temperature-controlled shipments grow in volume and regulatory requirements change, pharmaceutical and biotech manufacturers will need the support of their transportation-industry partners to ensure compliance with regulatory requirements and the safety and integrity of their high-value shipments.”

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