For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

Laboratory practice

Cold-chain monitoring in laboratory procurement

Risk-based shipping design, loggers and excursion assessment at receipt.

Risk-based shipping design, loggers and excursion assessment at receipt.

Cold chain is a system

The presence of coolant is not enough. Packaging, route, season, duration and transfer points affect risk. The configuration should be assessed for the actual shipping profile and stated material conditions.

Meaningful monitoring

A logger is positioned to answer the shipping question and has known calibration, range and sampling interval. Start, stop and time zone should allow alignment with the shipment. An indicator without history may provide less information than a complete time series.

Receipt assessment

The recipient checks integrity, monitoring data and documents before releasing material. An excursion is assessed against scientific evidence and a predefined procedure, not solely from the appearance of the package.

Sources and further reading

  1. WHO — Good storage and distribution practices
  2. EMA — Good manufacturing and distribution practice questions and answers
RESEARCH-USE BOUNDARY

For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

Back to all articles →