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Cold Chain Integrity

Meaning

The critical process of maintaining a required low-temperature range for a temperature-sensitive product, such as certain peptide hormones or biological therapeutics, from the point of manufacture through transport, storage, and final administration. Preserving this integrity is essential to ensure the chemical stability, potency, and therapeutic efficacy of the hormonal preparation. Any breach can lead to protein denaturation or degradation, rendering the medication ineffective and potentially unsafe for the patient.