Temperature-sensitive medications are filling the marketplace, so pharmaceutical cold chain storage needs to be reliable and effective. This article will look at what types of medicines require cold chain storage, how cold chain storage works, and the necessary freezers to maintain compliance.
The Types of Medicines Requiring Cold Chain Storage
The US Food and Drug Administration (FDA) approved 57 new drugs in 2017, with 23 being temperature-sensitive, meaning they require cold chain storage and transportation. They must be kept in a monitored environment where the temperature remains between 35.6ºF (2ºC) and 46.4ºF (8ºC).
There are five types of medicines requiring cold storage. Here is a brief explanation of each.
- Vaccines
Vaccines must be kept in an unbroken cold chain. If the temperature vaccines are stored or transported exceeds the prescribed limits, they can lose effectiveness. All parties in the cold chain, from the pharmaceutical manufacturers to pharmacies, doctors, and medical facilities, must monitor the temperature during transportation and storage. Vaccines that become too warm are useless if administered to patients and, depending on the type of vaccine, can increase the risk of spreading harmful viruses.
- Glaucoma Eye Drops
Glaucoma damages the optic nerve of the eye. When extra fluid forms in the eye, it increases pressure, which impacts the optic nerve. Glaucoma is a common cause of vision impairment for individuals aged 60 and older. Eye drops used to treat glaucoma are temperature sensitive and must be kept in pharmaceutical cold chain storage.
- Asthma Inhalers
Asthma inflames the lungs’ airways and has symptoms ranging from coughing and wheezing to shortness of breath and tightness in the chest. Common asthma treatments use an aerosol spray that a patient inhales through the mouth. These sprays, known as asthma inhalers, are most effective if stored in cold temperatures.
- Insulin
Diabetes is a disorder that results in high blood sugar levels. Type 1 and Type 2 diabetes are two different forms of the condition. Type 1 revolves around an insulin deficiency and usually first appears in childhood, where Type 2 is the development of insulin resistance requiring lifestyle changes and may require medication, including insulin. Not all insulin types must be kept in cold storage; however, they are still temperature sensitive.
- Biologicals
Biologicals are drug products from organic sources, including organs, tissue transplants, blood, or stem cell therapy products. Doctors commonly treat cancer and rheumatism with biologicals. These products’ storage temperatures must be monitored at all stages of the cold chain, or they will be ruined and lose their effectiveness.
How Cold Storage Improves Stability and Effectiveness of Medications
According to Dickson Data, proper monitoring of environmental conditions of temperature-sensitive pharmaceuticals is crucial. Those handling pharmaceuticals cannot break the cold chain from the manufacturing plant to distribution centers to pharmacies and medical facilities. Temperatures must remain within the ideal range up to the time when patients receive the medications from medical staff. Keeping the cold chain in place allows the medicines to last longer and not lose their effectiveness. Breakdowns in the cold chain result in significant losses, both in inventory and financial, and can pose a health risk to those using the medication.
A Closer Look At Cell Samples
Scientific discoveries in recent years have shown that there are many benefits in using cell samples and microbial strains. Many products have come from these studies, including biochemical enzymes, probiotics, and vaccines. Microbial strains and cell samples from tissues are incredibly fragile assets. Proper storage is essential as these biologicals provide value in research. Biologicals stored in ultra-low temperatures maintain a significant survival rate, and their genetics remain stable for more extended time frames. Both of these factors impact the usefulness of biologicals.
Cell Sample Cold Storage
Cell samples require ultra-low temperature storage compared to all other types of temperature-sensitive products. Ultra-low temperature storage units go down as low as minus 122.8ºF (minus 86ºC). The purpose of this type of storage is that the temperature slows down the metabolic rate and other biochemical processes in cells. With biologicals stored in such cold environments, the integrity of the cells is maintained. However, not all freezer units can reach and hold such ultra-low temperatures, so specialized units are on the market to address this need.
Final Thoughts
Having a reliable cold chain system is vital to the pharmaceutical industry and the medical profession, not only for storing temperature-sensitive products but also for maintaining these items’ effectiveness. With more drugs receiving approval from the FDA that require cold storage, there is a growing demand for cold chain solutions. Fortunately, there are ultra-low temperature freezers available to keep biologicals compliant and tools available to monitor the temperatures. When you consider the rapid pace at which technology has changed the way we do many of our daily activities, it only makes sense that technology would play a role in keeping sensitive medications appropriately stored so that they do not lose their effectiveness by the time they are needed.
