Make the cold room’s test conditions explicit.
State what the room stores, how it is used and which conditions the study must assess. Keep routine operation and deliberately introduced challenge tests separate in the proposed scope.
Request a mapping quoteDescribe the room before discussing sensors
- Room and storage configuration
- Share internal dimensions, shelving or rack layout, intended storage positions, and the room or refrigeration system identifier if available.
- Temperature requirements
- Provide the target range and the product or internal requirements behind it. Identify who can approve the study’s acceptance criteria.
- Operating information
- Describe loading, door use, refrigeration and defrost schedules if known, existing monitoring, and any recurring temperature concerns.
Separate routine conditions from challenge tests
A quote should not silently assume permission to interrupt refrigeration or expose stock to an abnormal condition.
- Empty or loaded conditions
- Confirm the required loading states and whether the room can be made available in those states. Record any operational limits on moving or removing stock.
- Door-opening and recovery tests
- If needed, define the proposed door-opening activity, recovery criteria and site supervision in the protocol. Do not leave the test conditions to be decided on arrival.
- Power-loss or other challenges
- Request these explicitly. The site must agree on authorization, product protection, stop conditions and restoration arrangements before any deliberate interruption.
Define the handover and the limits
- Report and supporting records
- Confirm the documented conditions, sensor placement and calibration records, data, deviations and analysis your reviewers require. The agreed protocol determines collection duration.
- Separate follow-up work
- Refrigeration repairs, alarm testing, ongoing monitoring and repeat mapping require an agreed scope. The study does not authorize product release or replace your quality review.
- Different equipment, different scope
- For a standalone refrigerator, freezer, incubator or chamber, send the equipment details instead of assuming this room-level plan applies unchanged.
Methodology and further reading
The WHO supplement covers cold rooms, freezer rooms and other temperature-controlled stores, but excludes small-scale refrigerators and freezers.
- WHO: Temperature mapping of storage areas, Supplement 8 (2015)
- ATEK guide to USP <1079.4>
- ATEK guide to ISPE temperature mapping
These resources inform scoping; they do not determine which requirements apply to your facility. Your quality team confirms the applicable requirements and approves the protocol.
Continue planning your study
Start with the information you have.
Tell us what needs mapping, where the site is and when you need the work. Mark unknown details as unknown. ATEK confirms service availability, scope and scheduling during review.