If you go into your medicine cabinet and pull out a bottle of pain relievers, you’ll find a tiny inscription that instructs you to keep the bottle at room temperature. When you go to the doctor to get a shot, the injection is extracted from a vial that had been stored in either a fridge or freezer. Pharmaceutical manufacturers, doctors, and many patients know why – improper temperature and humidity storage of an item can spoil it. Just like with fresh produce, there is an ideal storage climate and shelf life. However, while most of us can correctly assume that eggs will last longer in the fridge and shouldn’t be exposed to heat for longer than the trip home from the store, who among us knows the exact temperature range required to keep insulin effective? Forget efficacy alone – at what temperature does insulin no longer become safe? What is the limit for exposure?
The CDC suggests that medicines that require fridge storage, like vaccines, be stored between 35 and 46 degrees Fahrenheit (2C to 8C), and -13F to -14F (-25C to -10C) for freezer storage. But freezing can also cause destruction. Chemical analysis of a variety of tested subjects reveal that the active ingredients in an item can falter into degraded components, becoming oxidized or hydrolyzed. The change in the chemical makeup can render these medicines toxic, and the side effects of prolonged exposure vary item-to-item. Insulin stored at the wrong temperature can lose 20% of its efficacy. Improperly stored antibiotics can cause kidney and stomach damage. If a diabetic took insulin that had become poisoned by exposure, the results would be devastating – but thankfully, preventable. This is why environmental simulation testing is so important.
Testing the exact environmental ranges of pharmaceuticals and biotech is essential to the efficacy of the item and safety of patients. To determine the exact range of temperature and humidity each vaccine or medication must be stored at for proper efficiency and safety, pharmaceutical manufacturers need to employ environmental simulation technology, which offers three applicable equipment subsets:
Temperature Chambers
Temperature chambers are able to stimulate vast temperature ranges and rapidly alter between hot and cold temperatures, testing a vaccine or medication’s ability to withstand extremes. These tools will determine the exact temperature range a vaccine, injection, or other biotech can bear before chemical degradation. Many offer adjustable shelving, so that you can test a large batch of vaccines at once.
Recommended Product: TPS Tenney Jr Compact Junior Temperature Chamber
Temperature & Humidity Chambers
Like temperature chambers, a temperature and humidity chamber can rapidly cycle through temperature extremes, as well as simulate other environmental conditions like altitude, moisture, relative humidity, electrodynamic vibrations, and weathering. The added testing for humidity related conditions is why you’ll often see medicine labels instructing you the keep the bottle in a cool, dry location.
Recommended Product: Espec SH-242 Bench-Top Type Temperature & Humidity Chamber
Temperature Forcing Equipment
Similar to both temperature and humidity combination chambers, temperature forcing equipment is able to determine a substance's resistance to heat, cold and humidity. The difference between these systems and a temperature forcing unit is size. While chambers can range from a compact, benchtop variety to larger units that can hold entire pieces of equipment (often for military or aerospace purposes), temperature forcing devices can test and cycle only samples with a small cubic area (like vaccines), making it perfect for pharmaceutical use.
Recommended Product: Thermonics T-2500SE Temperature Forcing Systems
Knowing the precise temperature and humidity range of the pharmaceuticals and biotech you manufacture is essential to product efficacy and safety. The health of patients and the effectiveness of their vital medicines starts with you, and requires specialized environmental simulation technology to test biotech limits. To learn more about this equipment, or inquire about a specific temperature and humidity forcing product, please feel free to contact our Environmental Team Leads at 800-404-2832.
Posted July 06, 2017