The Importance of Drug Storage Temperature in Cold Storage

1 day ago

Drugs play an important role in helping the healing process and relieving disease symptoms. However, their benefits can only be maintained if the temperature of drug storage in cold storage is properly controlled.

In addition to food products, cold storage is now also widely used in the pharmaceutical sector to maintain the stability of certain drugs with specific storage standards. Improper storage can damage drug quality and reduce the effectiveness of the active ingredients in them. Therefore, drugs need to be stored in safe conditions to avoid physical or chemical damage.

So, why does the temperature of drug storage in cold storage facilities need to be strictly monitored? Check out the complete explanation in the following article.

Why Does Drug Storage Temperature Require Special Attention?

Not all drugs can be stored at room temperature. Some types, such as vaccines, insulin, hormones, enzymes, suppositories, and biotechnology products, are very sensitive to changes in temperature and light. If stored at inappropriate temperatures, drugs can lose effectiveness, experience degradation of active substances, and even pose risks to patients.

Basically, drug storage aims to maintain stability, safety, and quality so that they remain optimal when used. Therefore, drugs must be placed in special rooms that are not mixed with other goods and must follow the instructions on the packaging, for example storage in refrigerators at temperatures of 2°C–8°C for certain types.

Storage standards also need to be adjusted based on dosage form, material properties, temperature stability, resistance to light, and arrangement systems, such as alphabetical order and FEFO (First Expired First Out).

In short, maintaining drug temperature and storage systems is not merely a technical procedure, but an important part of ensuring that drugs remain safe, stable, and provide benefits according to their function.

Types of Drugs That Require Cold Storage

Some types of drugs require storage in cold storage because they are highly sensitive to temperature changes. If not stored at the correct temperature, the quality and effectiveness of the drugs can decrease. Here are some examples:

Vaccines: Most vaccines must be stored at temperatures of 2–8°C to remain stable and effective when used.
Insulin: This medication for diabetes patients is sensitive to heat, so it needs to be stored in cold conditions.
Biological injection drugs: For example, monoclonal antibodies that require low temperatures to maintain stability.
Enzymes and hormones: These substances are easily damaged if stored at excessively high temperatures.
Biotechnology products: Including some modern therapies, such as gene therapy, which require strict temperature control during storage.

What Is the Drug Storage Temperature in Cold Storage?

Temperature is the main factor in storing drugs in cold storage facilities. Based on WHO, BPOM, and Indonesian Pharmacopoeia guidelines, drugs and pharmaceutical products are stored within certain temperature ranges to maintain their quality and stability.

In the pharmaceutical cold chain system, storage is generally divided into several categories, namely:

Chilled temperatures are in the range of 2–8°C and are usually stored in chillers or cold rooms.
Frozen pharmaceutical temperatures range from -25°C to -10°C.
Some special products, such as certain vaccines, are stored in ultra-low frozen conditions at temperatures around -70°C or lower.

In practice, cold chain products, such as Cold Chain Product (CCP), are stored in chillers at temperatures of 2–8°C or in frozen storage at temperatures of -18°C to -23°C.

Product arrangement should also not be too dense and products need to be spaced from walls and from each other to ensure even air circulation.

Storage temperatures must remain stable and not fluctuate because temperature changes, even by only a few degrees, can affect drug quality, especially in terms of active substance stability, drug effectiveness, and safety.

Effects of Drugs Not Stored at Proper Temperatures

Improper drug storage temperatures can cause various problems with their quality. Drugs stored carelessly may experience changes in active ingredient content so that their benefits are no longer optimal and may even endanger users. In addition, drugs can deteriorate more quickly even before reaching their expiration date.

It should be noted that expiration dates only apply if the drug is still in its original packaging, unopened, and stored according to the instructions on the label. Once the packaging is opened, the stability of active substances can decrease or become contaminated by germs.

Some drugs have specific expiration periods after being opened. For example, eye drops can only be used for a maximum of 30 days after the packaging has been opened.

Drug damage caused by improper storage can also be identified from physical changes, such as unpleasant odors, the appearance of black spots, cracking, or becoming damp. These conditions indicate that the drug is no longer suitable for use.

Tips for Choosing Safe Cold Storage for Drugs

Choosing cold storage for drug storage cannot be done carelessly. The facility used must be able to maintain temperature stability while also meeting pharmaceutical storage standards so that drug quality remains maintained. Some important things to consider include:

Use pharmaceutical-specific cold storage so that it is not mixed with other products, such as food.
Ensure there is an automatic temperature monitoring system to keep temperatures stable during storage.
Utilize monitoring technologies, such as IoT sensors to monitor temperature and humidity in real-time, as well as data loggers that record temperature history as proof of regulatory compliance.
Provide automatic alarms that will give warnings if temperatures exceed standard limits.
Perform routine calibration of temperature sensors to ensure monitoring results remain accurate.
Use the FEFO (First Expired, First Out) system to ensure drugs with the nearest expiration date are used first.
Provide backup power sources, such as generators or UPS systems, so that cold storage continues functioning during power outages.
Implement storage SOPs that follow WHO and BPOM standards.

With the right facilities and management, storing drugs in cold storage can help maintain the quality, safety, and effectiveness of drugs until they reach users.

That is the explanation regarding the importance of drug storage temperatures in cold storage facilities to maintain drug quality and stability.

Storage at the correct temperature helps prevent changes in drug properties so that their content and effectiveness remain maintained until used by patients.

In cold chain logistics practices, the management of storage and distribution of temperature-sensitive products requires integrated systems and accurate monitoring.

MGM Bosco Logistics is an end-to-end cold chain logistics service provider supported by refrigerated warehouse facilities, more than 1,000 refrigerated trucks equipped with thermo-loggers and GPS, as well as warehouse and transportation management systems that enable real-time operational monitoring.

For those of you who would like to consult further regarding cold storage solutions or cold chain logistics services, contact the MGM Bosco team now!