Dos and Don’ts for Storing Temperature Sensitive Medicines
The UK Medicine and Health Products Regulatory Agency (MHRA) identified crucial mistakes in how wholesalers source and handle freezers and fridges used to store medicines.
MHRA says the main metrics to measure when sourcing GDP qualified equipment are:
- The purpose – is it to store cold packs to be used in transit or to host frozen products?
- Temperature bracket required
- Defrost capabilities
- Sanitation access
- Speed of cooling materials to desired temperature
- Risk impact of the installation – how the heat produced by the freezer will impact the close environment
The body clarified domestic freezers may not have the capability to quickly freeze cold packs from room temperature because of their small compressors and fans. Also, automatic defrost settings may risk causing temperature excursions.
Some suggestions include:
- Don’t store products on the floor of the unit as this could block air circulation and consistent temperatures in the whole unit.
- Do position probes in a central location amidst products and not in the door of the unit.
- Do clean regularly and test audible or visual alarms to verify their function.
Storing Temperature Sensitive Medicines
On receiving medicines, handlers should question whether they have been distributed in acceptable conditions.
Dual freezer or refrigerator units are positive for reducing footprints and costs however, if that dual unit malfunctions that will impact both compartments and their contents. Also, one compressor attached to two units may struggle to support both units adequately simultaneously.
There will not be a vast amount of medicines that require freezing and so small freezers are often used. The MHRA has seen some venture to store other items in the freezer next to the medicines to fully utilize the space, for example to condition cold packs. However, MHRA warns that this can lead to contamination and temperature excursions if a lot of unconditioned cold packs are loaded in bulk. Excessive access to the freezer could also cause temperatures to dip.
Read the full Pharma IQ article here.