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Protecting medicines through cold chain distribution

Temperature-controlled distribution involves multiple variables, as discussed here with Geoffrey Glauser, vaccine and therapeutic supply chain contractor and subject-matter expert with Conceptual Mindworks, Inc.

Healthcare Packaging (HCP): Please describe your company’s responsibilities?

Geoffrey Glauser: Conceptual Mindworks supports the mission of Health and Human Services, Office of the Assistant Secretary for Planning and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA). The Office is responsible for coordinating research and development toward new vaccines, diagnostics, and drugs related to the pathogenic organisms most likely to be used in a natural or terrorist attack on the U. S. homeland. BARDA works with all scientific agencies of the HHS Department, including the National Institutes of Health (NIH), the Center for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), as well as state and local governments, private, and non-profit scientific entities.

HCP: Regarding the packaging and shipping of temperature-sensitive pharmaceuticals, biologics, etc., many are familiar with the 2 to 8 C "cold chain," but how would you define the other temperature ranges companies are concerned with?

More and more the temperature-controlled shipping arena is focusing on transfers of material outside of the 2°C to 8°C range. Principally, controlled-room shipping, 15°C to 30°C or ambient temperature shipping is examined. This is based on the fact that many pharmaceutical raw materials, intermediates, and finished goods may not have indefinite stability when exposed to other than long-term storage conditions as stated on package inserts, Material Safety Data Sheets, or Certificates of Analysis. Consequently, there needs to be a broader data-based approach to the transfer of materials either in controlled or uncontrolled conditions depending on whether there is stability data available to support such shipment.

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