PeptidePedia The community reference

Cold-chain freight (revision 1)

Old revision·09:00, 16 Oct 2024·FreightFenna

This is an old revision of this page, as it stood at 09:00, 16 Oct 2024, saved by FreightFenna with the summary start article on the process step. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Cold-chain freight
Passive systemsInsulation plus phase-change material
Active systemsPowered refrigeration
Evidence of performanceA temperature record, not a cold pack
Topic infobox · conventions

Cold-chain freight is transport under controlled temperature. For peptides it is used to limit the degradation routes — deamidation, oxidation, aggregation — whose rates rise with temperature, and its performance is a matter of record rather than of appearance.[1]

A passive shipper is insulation plus a phase-change material, designed to hold a temperature range for a stated duration under a stated ambient profile. It does not hold indefinitely, and a shipment that takes longer than the design duration is outside the qualification whatever the pack looks like on arrival.[2]

Passive and active systems

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Passive shippers are qualified by testing against defined ambient profiles: a summer profile, a winter profile, and a duration. Qualification states what the system will do under those conditions, and nothing about what it will do outside them.[2]

The coolant matters. Gel packs conditioned to refrigerator temperature hold a chilled range; frozen packs can take contents below the intended range, and freezing is a distinct hazard for a solution. Phase-change materials formulated to melt at the target temperature avoid both extremes.

References

  1. ^ International Council for Harmonisation, Q1A(R2): Stability Testing of New Drug Substances and Products (2003).
  2. ^ a b United States Pharmacopeia, General Chapter <1079>, Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.