Improper Commercial Temperature Monitoring: Risks and Solutions

Pharmaceutical companies increasingly produce new drugs and vaccines at high cost. To protect your investment of time and money, preventing loss of potency is essential. A best practice to ensure proper administration of your products is to maintain their optimal temperatures during operations that involve storage and transit and require commercial refrigeration.

What are the risks of improper commercial temperature monitoring?

Sometimes manufacturers prefer the least restrictive storage conditions possible. Although that preference may benefit your marketing and sales divisions in the short term, a lack of rigorous standards can seriously compromise a product’s safety and efficacy. In fact, according to a recent commercial temperature monitoring study, chemical analyses have revealed that the further out of range the temperature, the greater degree of degraded by-products.

The study points out some serious risks to a lack of commercial refrigeration monitoring:

• Oxidized and hydrolyzed components that are toxic
• Changes in formulation and color
• Modified dissolution rate
• Separation of emulsions
• Loss of therapeutic value caused by freeze-thaw cycles

Pediatrics Study: Storage Risks in Commercial Refrigeration

Another study of temperature monitoring for commercial fridges in Pediatrics discovered that vaccines stored at sub-optimal temperatures (≤1°C or ≥9°C) were at risk of degradation. Major risk factors included:

• Lack of thermometer in refrigerator or freezer
• Use of a freezer compartment in small cold storage units
• Failure to keep a log of recorded temperatures

Do these storage mistakes sound familiar? If so, it’s time to take corrective action.

Temperature Monitoring Solutions in Pediatric Medicine

The same study offers the following strategies to rectify improper storage temperatures:

1. Don’t store frozen vaccines in freezer compartments in less than full-sized refrigerators
2. Monitor temperatures in both the refrigerator and freezer compartments
3. Ensure that vaccines do not freeze
4. Follow standard procedures when a power outage occurs
5. Inventory and rotate vaccines in cold storage each time new vaccines are delivered
6. Review temperature-monitoring practices
7. Train all vaccine-handling employees about the importance of temperature control

A final takeaway? The study concludes that a modest financial investment in commercial refrigeration monitoring can avoid the risks of suboptimal temperatures, including the purchase of temperature monitoring equipment.

Download our white paper, The Importance of Temperature Monitoring for Medication Safety and Efficacy.

The two studies point at the same gap

The commercial study in this article ties a wider temperature miss to more degraded by-products, including loss of therapeutic value after a freeze-thaw cycle. The Pediatrics findings name the everyday version of that miss: no thermometer, a freezer compartment inside a small refrigerator, and no temperature log. The fixes are the ones this article already lists. Monitor both compartments, do not let vaccines freeze, keep a log, and train the people who handle the product.

Related reading

For more on temperature monitoring, read Essential Temperature Control Tips for Restaurant Food Safety and What Is Time/Temperature Control for Safety (TCS)?.