Designing a pharmaceutical cold room
Six things decide whether a medical cold room passes inspection and protects stock. Uniformity: every shelf must sit within +2 to +8 °C, proved by temperature mapping that finds the warmest and coldest points. Resilience: two refrigeration systems, or a standby unit, so a single failure does not take the room out of range, and an alarm on power failure. Monitoring: calibrated probes at the mapped hot and cold points, continuous logging and alarms that reach a person out of hours. Door discipline: an air curtain, strip curtain or ante room so openings do not push the room out of range. Validation: installation, operational and performance qualification documents (IQ, OQ and PQ) for your Good Distribution Practice file. Layout: shelving that lets air circulate, space for quarantined and returned stock, and room to grow. See our cold rooms page for how a room is built.
Storing medicines and vaccines
Cold chain medicines and vaccines are stored at +2 to +8 °C and must never freeze: a vaccine that has frozen is discarded. Most other medicines are kept below +25 °C in controlled ambient storage, and some products need a freezer at -20 °C. Stock is kept off the floor, away from walls and the cooling unit, rotated by expiry date, with quarantine and returns segregated. Temperatures are checked and recorded at least daily by hand, or continuously by a logger, as the MHRA expects. Where a site holds both chilled and frozen products, see our freezer rooms page.
Temperature monitoring, mapping and records
Good Distribution Practice requires continuous temperature monitoring with calibrated probes, records you can produce at inspection and alarms when the room drifts out of range. The room is mapped before use, with loggers placed across the shelves for several days, and mapped again when the layout changes or across the seasons. Probes for the permanent monitoring go where mapping found the extremes, not beside the evaporator. The monitoring is specified and installed with the room, so it is working before the first delivery, and the records are kept for the period your licence requires.
Laboratory and mortuary cold rooms
Laboratory cold rooms hold samples and reagents at +4 °C, often with people working inside, so they are built with lighting, benching, ventilation, an internal release and an alarm. Mortuary body stores are held at +2 to +4 °C, with deep-freeze storage at -20 °C for longer-term holding, built with racking, stainless steel finishes and the discretion the setting needs, in line with Human Tissue Authority guidance. Larger wholesalers with pallet storage are covered on our commercial cold storage page.
Compliance for medical cold storage
- The Human Medicines Regulations 2012 and the MHRA's Good Distribution Practice guidelines for wholesalers holding a WDA(H) licence.
- General Pharmaceutical Council standards for pharmacies, including daily temperature checks and records.
- Human Tissue Authority codes of practice for mortuaries.
- The F-Gas Regulations for the refrigerant, with leak checks by certified engineers.
- Health and safety rules for anyone working inside a cold room: internal release, alarm and limits on exposure.
Why pharmacies and laboratories choose Alaska Cold
- Rooms designed for uniformity and resilience first, with the monitoring and documents that inspection needs.
- One team installs, maps, monitors and maintains the room, with planned maintenance and F-Gas records handled for you.
- 24/7 emergency line, because a cold chain failure at night is a stock loss by morning.
Planning a medical cold room or replacing pharmacy fridges with a walk-in? Tell us what you store and we will arrange a survey.