Cold chain: what it is and when it matters in HOF
Quick facts
- Definition
- A set of temperature conditions maintained from the manufacturer to the point of use.
- Common range
- Many products call for refrigeration between 2 and 8 degrees Celsius; the package insert rules.
- Sensitive products
- Botulinum toxin and hyaluronidase, among others.
- Failure
- Loss of potency or safety of the product, with no visible sign.
- Control
- Thermometer, temperature log and a receiving routine.
The cold chain is the set of temperature conditions a product must keep from manufacture to the moment of use. For sensitive products, a break in this chain can change potency or stability, with no visible sign on the vial.
Which HOF products depend on it?
| Product | Note |
|---|---|
| Botulinum toxin | Usually requires refrigeration, before and after reconstitution; the package insert sets the range and shelf life |
| Hyaluronidase | Sensitive protein, with its own storage instructions |
| Some biostimulators and others | They vary: follow the packaging |
| Many fillers | Usually kept at controlled room temperature, also according to the package insert |
The rule is simple and non-negotiable: the manufacturer's package insert applies, not memory or habit.
How does a failure show up?
It can show up as a weaker effect than expected, a short or variable response. In general, there is no visible sign that the product lost quality. That is why prevention is safer than diagnosing after the fact.
How to organize the routine
- Receive the product, check the packaging and seal, and store it right away.
- Use a dedicated refrigerator, with a thermometer and a temperature log.
- Check the expiration date and the health registration.
- Note the lot and expiration date in the patient record.
- Do not mix with food or personal items.
- Have a plan for power outages.
Suspected product events can be reported through technovigilance channels.
Also called: cold storage, product refrigeration.
Frequently asked questions
Can a product that was left out of the refrigerator be used?
It depends on the package insert and the time of exposure, and it is not always possible to know the effect. When in doubt, the product should not be used, and the supplier or manufacturer should be consulted.