When working with pharmaceuticals, errors can have significant impacts on consumer safety and well-being. Proper storage plays a vital role in drug safety and effectiveness so adequate storage conditions must be prioritized. Pharmaceutical stability storage allows medications and other drugs to be stored appropriately so the efficacy and longevity are not affected by temperature and other environmental factors, like light and humidity.
Temperature-Controlled Pharmaceutical Storage
While there may be variation in storage requirements, all pharmaceuticals need to be properly stored 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 that may not be visually noticeable, but this degradation can cause real problems when administered.
In some cases, improper temperature storage can even alter a drug’s physical properties. For example, medication may start to change in color and texture or could start to emit a foul odor or taste. These physical changes will typically indicate that a drug is no longer as effective as intended or could cause harm to the consumer.
In recent years, more pharmaceuticals have been produced that can retain their potency and integrity in low temperature ranges (within a range of 2°C to 8°C). After all, even 2° C changes in temperature could completely ruin a pharmaceutical product. These cold chain conditions have 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. Utilizing pharmaceutical stability storage and testing, manufacturers can determine the optimal conditions to store ingredients and final products along with details regarding their shelf-life and ideal packaging.
Proper Pharmaceutical Stability Storage Conditions
Every pharmaceutical has a unique margin of error in terms of proper temperature storage, which means there are strict guidelines in place to ensure that all drugs remain within their recommended temperature ranges. While temperature ranges are determined by stability testing of the individual drug manufacturers, the World Health Organization states that temperature-controlled pharmaceutical storage requires an environment with good ventilation, no odors or light, and relative humidity levels of 60% or lower.
Due to the environmental factors that can negatively impact medicines and other drugs, many companies rely on pharmaceutical 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, simpler, 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.
To learn more about how our pharmaceutical stability storage facilities can allow you to store with accuracy and compliance standards in mind, please contact us today.