What standards must cold-chain facilities (such as cold rooms and refrigerated vehicles) used for biological products requiring cold storage meet?

When handling medicines that require cold-chain storage, such as vaccines and insulin, cold-chain facilities must meet very stringent standards to ensure that the medicines remain within the specified temperature range (usually 2-8°C) throughout storage and transport. First, cold rooms and refrigerated vehicles must undergo a professional Temperature Mapping Study to demonstrate that temperatures at all points inside can be kept consistently within the required range. This validation must be carried out under both empty and fully loaded conditions. Second, all temperature-controlled equipment, including cold rooms, refrigerators, refrigerated vehicles and portable coolers, must be equipped with independent, calibrated temperature monitoring and alarm systems. Third, detailed Standard Operating Procedures (SOPs) must be established to cover all aspects, including routine use, cleaning, maintenance, calibration and emergency response (such as power failure). During transport, validated insulated shippers must be used together with temperature data loggers that record temperatures throughout the journey.