+2 to +8 °C
The specification +2 to +8 °C defines a controlled refrigerated range. Where it is prescribed for a product, the relevant product temperature must be maintained within these limits. Which goods require this range follows from their specifications; it does not apply universally to all medicines or laboratory samples.
Why does the lower limit also matter?
- Cooling elements that are too cold can overcool freeze-sensitive products. Falling below +2 °C is already an excursion from the range, but is not proof of freezing damage.
- Hot ambient conditions can cause temperatures above +8 °C if insulation, cooling medium or protection duration are insufficient.
- The sensor position must suit the assessment. Air temperature outside the shipper does not describe product temperature.
How is compliance demonstrated?
The complete packaging, defined payload and relevant ambient profiles are tested. Suitable monitoring supports control during shipping. A temperature excursion is assessed using its duration, temperature history and product data; these do not support blanket release decisions.
Related terms: Cold Shock · Temperature Monitoring / Data Logger
Technical references:
EU GDP Guidelines: particularly Chapter 9
WHO: Cold boxes and vaccine carriers