Freezing is extremely damaging for many pharmaceutical products, so pharmacies, carers and increasingly patients need a way to determine whether their products were/are frozen during transport. The new FreezeSafe indicator from SpotSee provides this information.
Although some vaccines need to be frozen or deep-frozen, many vaccines, biologics and other medicines can be damaged by freezing. HUMIRA® (adalimumab), a drug used to treat ulcerative colitis, and Pradaxa (dabigatran), an anticoagulant, are two of many possible examples. Some, such as insulin (used to treat about 29 million Americans with diabetes), can become completely ineffective or even life-threatening if frozen.
Pharmaceutical developers and distributors go to great lengths to use the right protective packaging when shipping medicines and diagnostics. But sometimes this packaging fails, is damaged or is not used correctly.
A large pharmaceutical logistics company reported such an incident at a conference a few years ago. A warehouse worker was cautious about maintaining the refrigeration temperatures for a particular package in the cold chain and placed it in the refrigerator until the carrier arrived. This drop in temperature was enough to freeze the contents and damage the medicine.
It is clear that such accidents happen.
With remote treatment, more and more medicines and diagnostics are being delivered directly to patients' homes and - in the case of diagnostics - from home to a laboratory. Before the Covid-19 pandemic, the market for home delivery of medicines was expanding and this growth has continued ever since. This means that medicines, tests and patient samples (e.g. blood or other fluids) can be exposed to cold temperatures in the hold, on the terrace or in the letterboxes over the last mile or across the country.
Infusion pharmacies and clinics, distributors, hospitals, doctors' surgeries and retail pharmacies must ensure that their products are not affected by accidents, either during import or delivery. They and their patients must be sure that products that cannot be frozen are not frozen at any point in the supply chain to ensure that these medicines, vaccines or diagnostics are as effective as when they were manufactured.
Unfortunately, freezing is not always obvious. Medicines can freeze and thaw during transport without anyone knowing about it. Some become cloudy, while many others show no visible signs of freezing. As a result, not even pharmacists can look at a medicine and know if it is frozen and thawed before receiving it.
For these reasons, SpotSee has developed the FreezeSafe product line. FreezeSafe disposable indicators clearly indicate if unacceptably low temperatures have occurred at any time between the time the indicator is placed on the product and the time it arrives.
When these indicators change colour from white to magenta, patients, pharmacists or other people can see at a glance whether the temperature has dropped to a dangerously low level. To trigger the colour change, the temperature must fall below 2 °C for 90 minutes or below 0 °C - the freezing point - for 60 minutes. The new SpotSee freeze indicators are accurate to +1°C.
These new freeze indicators have been designed in a format that fits easily on life science products, but still contains the information that is important to SpotSee customers. And because they are very flat, manufacturers can continue to use their usual packaging materials. The low-cost freeze indicator is self-adhesive, so all the user has to do is peel off the film and stick the indicator on the product or in the packaging.
The FreezeSafe indicators from SpotSee are now available as a stand-alone product and as part of the SpotSee Cold Chain Complete, which indicates both too cold and too warm temperature excursions.