Understanding the Importance of Temperature Control in Pharmaceutical Stability

If you regularly work with pharmaceuticals, you’ll already understand the importance of dispensing those drugs properly. An error during this stage could have a significant impact on consumer safety and well-being. The same can be said of errors made during the storage phase. Pharmaceutical storage plays a vital role in drug safety. Therefore, adequate storage conditions for pharmaceuticals must be prioritized. Let’s take a more detailed look at how temperature can affect medications and other drugs, as well as why you’ll need a superior pharmaceutical storage solution to ensure these products retain their potency as intended.


Each physical stability of pharmaceutical products and temperature controlled drug storage may have slightly different storage requirements — but all pharmaceuticals need to be properly stored in order to ensure they remain within a specific temperature range. When a drug is stored in temperatures that are too high or too low, the drug’s chemical stability will likely be impacted. That means that the drug may degrade and form impurities. While these impurities may not be visually noticeable, this degradation can cause real problems when the drug is administered.

In some cases, improper medicine temperature storage can even alter a drug’s physical properties. A medication may start to change in color and texture, for example, or could start to emit an odor or taste foul to the consumer. These physical changes will typically indicate that a drug is no longer as effective as intended or could actually cause harm to the consumer.

In recent years, more pharmaceuticals have been produced that can retain their potency and integrity in low temperature ranges. Cold chain, a type of pharmaceutical cold storage, involves keeping medications within a range of 2 and 8 degrees Celsius. This type of pharmaceutical storage has become more preferable as of late, though it requires the complete cooperation of the manufacturer, the shipping company, and the wholesale seller to ensure these drugs are safe for use. Not all medications can be stored in cold chain conditions, but they still must be kept in the proper temperature range outlined by the manufacturer to meet compliance standards and to mitigate risks.


Every pharmaceutical has a unique margin of error in terms of proper medicine temperature storage, which means there are strict guidelines in place to ensure that all drugs remain within their recommended temperature ranges. After all, a mere two degrees (Celsius) difference in temperature could completely ruin a given pharmaceutical product. According to the World Health Organization, pharmaceutical products must be stored in an environment with good ventilation, no odors or light, relative humidity levels of 60% or lower, and temperature ranges published by the individual drug manufacturer. Although general storage temperatures range between 15 and 25 degrees Celsius, we’re now seeing lowered temperature requirements as a way to protect these drugs from degradation.

In most cases, pharmaceutical companies will rely on stability storage facilities to make certain that these drugs are always kept in the correct conditions. Because there is no room for error, it’s often safer and more cost-effective to rely on an outsourced stability storage provider to provide complete compliance and accuracy. Not only will this help to maintain the chain of custody, but it also makes certain that there are backup procedures in place when needed. Trying to handle these tasks yourself can quickly become expensive and overly complex. But entrusting a pharmaceutical stability storage company with this responsibility is often in the best interest of the manufacturer, the supplier, the wholesaler, and the customer.

To learn more about how our stability storage facilities can allow you to store your pharmaceutical samples with accuracy and compliance standards in mind, please contact us today.


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