The Role of Cold Storage in Pharmaceuticals
Oct 2024

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Cold Storage

Safeguarding Health : The Role of Cold Storage in Pharmaceuticals

Pharmaceuticals are life-saving medical supplies that need to be stored in a controlled environment to preserve their efficiency. However, maintaining the precise temperature within the room throughout the cold chain supply can be a challenge in itself. This is where cold storage becomes a game changer. Considering this, many of you may have queries about the role of cold storage in Pharmaceuticals. So what is its role? The pharmaceutical industry requires temperature regulation from production to distribution, and cold storage offers a reliable way to ensure that sensitive materials remain stable. This also prevents spoilage or damage to items.

In this blog, we explore some of the key roles of cold storage in pharmaceuticals for safeguarding public health. Along with this, we also cover briefly the types of cold storage that the pharmaceutical industry needs.

What is Cold Storage in Pharmaceuticals?

Before we dive into details on the role of cold storage in pharmaceuticals, let's first talk about cold storage in brief. So, what is cold storage in Pharmaceuticals? Cold storage in pharmaceuticals is a warehouse with thick insulated floors, ceilings, and walls. The facility makes sure that the temperature for storing vaccines, drugs, and other biologics remains within the pre-defined range.

Several types of cold storage exist in the market. It includes refrigerators, freezers, and large-scale cold room units, and its objective is to store perishable pharmaceuticals and protect their integrity by stabilizing the low temperatures. The temperature-controlled units allow you to get control over temperature and humidity so that you can adjust them to retain the efficacy of pharmaceuticals and other biologics.

Types of Pharmaceutical Cold Storage

Types of Pharmaceutical Cold Storage

As you are familiar with what cold storage is, let's discuss the types of pharmaceutical cold storage. They are influenced by factors, including the construction materials, type of product stored, and temperature requirements. But, the category mainly depends on the temperature they must maintain. Some of these types include.

1. Refrigerated Cold Storage

Refrigerated cold storage maintains temperature ranges from 2°C to 8°C. Insulin and a few biological products can be stored in refrigerated cold storage. This type of commercial cold room is used for products that require cooling but not freezing conditions. 

2. Frozen Cold Storage

As you can guess from the name, the temperature in cold storage is designed to store a medication that needs a consistently frozen environment. The temperature around the storage operates between -20°C and -40°C

3. Ultra-low Temperature Cold Storage

The ultra-low temperature cold storage involves a very cold environment, and here, the temperature is typically maintained at -70 °C and -80°C. They are designed for biologics that need long-term freezing conditions. This type of storage is a must for preserving mRNA vaccines.  

4. Cryogenic Cold Storage

Last but not least, cryogenic cold storage comes with extremely low temperatures. They are used to safeguard biological samples, stem cells, and gene therapy. This pharmaceutical cold storage protects the said medical material’s viability at -150 °C and below temperature.

These are the main types of storage facilities in pharmaceuticals, each offering unique features and capabilities to meet the diverse storage needs of the products.

Benefits of Pharmaceutical Cold Storage 

Benefits of Pharmaceutical Cold Storage

As you may have guessed from the definition, it's not surprising to know that cold storage is essential in an organization such as pharmaceuticals, where you need to maintain a consistent temperature. You might be wondering about the specific benefits these storage facilities serve. So, what are the key benefits of pharmaceutical cold storage? Some of those common benefits include.

  • Cold storage rooms protect perishable pharmaceutical products like vaccines, drugs, and biological materials. The controlled environment prevents these perishable products from degrading while extending their shelf-life.
  • In a pharmaceutical setting, the cold room facilities enable the storage of large quantities of perishable products. This helps in the efficient inventory tracking system, minimizing complications like stock imbalance and handling product expiration.
  • By maintaining the product’s potency, cold storage ensures fresh and high-quality medicines and vaccines throughout the supply chain. This also allows easy access to essential supplies throughout the year.
  • Cold room facilities also assist organizations in complying with strict regulatory requirements for storing temperature-sensitive products.
  • Investing in a cold room makes cold storage pharmaceuticals free from the risk of harmful microorganisms and pathogens. 
  • Cold storage is an integral aspect of research facilities and laboratories. These sectors demand precise temperature control when they need to preserve reagents and samples that cold storage pharmaceutical offers. 
  • The advanced cold room prioritizes energy efficiency methods. These facilities are equipped with features like insulation and compressors that reduce electricity consumption and operational costs in the long run.

These are only a few of the main benefits that the cold room serves. The benefits of pharmaceutical cold storage vary depending on how you use the cold rooms. Regardless, we provided you with the fundamentals of the benefits of cold storage.

Importance of Cold Storage in the Pharmaceutical

Importance of Cold Storage in the Pharmaceutical

Now that you have learned the reasons why cold storage is needed in the pharmaceutical industry let's shift our focus to discussing its importance. There are many important ones, some of them include.

1. Maintain appropriate temperature

The pharmaceutical industry needs a controlled environment consistently throughout the supply chain. If the products are compromised due to temperature fluctuation, then the risk of spoilage is higher. Investing in pharmaceutical cold storage gives you peace of mind regarding temperature management as they have monitoring tools, temperature regulators, and automatic refrigeration.  

2. Extending the Shelf Life of Products

One of the benefits of cold storage is that it extends the shelf life of medicinal supplies. The cold storage is designed with a precise temperature regulator. The controlled environment in cold storage areas prevents microorganism growth and enzymatic reactions and also reduces the frequency of waste caused by spoilage.

3. Avoid Financial Losses

Cold storage not only extends the shelf life of pharmaceuticals but also minimizes your financial threat. But how, you may ask? The large quantity of products gets spoiled if you neglect the temperature variation during storage. This means you need to remove those products, contributing to wastage of resources and financial loss. With proper cold storage in place, all these potential losses in revenue can be prevented by allowing the organized storage of large quantities of pharmaceuticals for a longer duration.  

4. Efficient Health Care

As previously stated, cold storage in pharmaceuticals safeguards medicinal products like vaccines, drugs, and medications. As the effectiveness of these life-saving items is preserved at the right temperature,  this improves the treatment process and ensures patient safety. Therefore, setting up good cold storage means enhancing public health care. 

5. Inventory Management

One of the crucial benefits that you get from pharmaceutical cold storage is reliable inventory management. In simpler words, cold storage provides you with storage access to large quantities of pharmaceuticals, drugs, and vaccines. This also reduces the waste and need for frequent deliveries.

6. Security Measures

Cold storage facilities are primary targets at the risk of intruders and other criminals. The good news here is that cold room storage comes with an advanced locking mechanism. These advanced features play an important role in safeguarding valuable and delicate pharmaceuticals. Also, by restricting access to only authorized individuals, these security measures effectively deter theft and tampering.

Also Read : Importance of Cold Storage Rooms in Hospitals

Conditions for Pharmaceutical Cold Storage

Pharmaceutical cold storage is a specialized storage facility that should follow certain guidelines to maintain the quality of pharmaceuticals. We offer you the general conditions of a cold storage room in pharmaceuticals so that it functions at optimal capacity. Some of the conditions are:

1. Temperature Control

The cold storage room should be installed with the best temperature control tools. This involves thermostats and sensors that send messages to the refrigerated system to turn on or turn off based on the temperature of the room. If the temperature exceeds a specific temperature, then it tells the system to cool down and vice-versa. 

2. Validation and Compliance Check

The agencies, including EMA, WHO, and the FDA, mandate that your pharmaceutical business handle and distribute medications and vaccines within a specific temperature range. Any non-compliance with the regulations results in product recalls, penalties, and harm to your company’s reputation. Thus, from handling to distribution, it is a must to install cold storage that maintains the product’s potency and efficiency throughout the cold chain supply. 

3. Alarm System

Alarm systems are the most useful security measure that needs to be integrated into your cold storage room. This alarm assists in taking timely control of the emergency and avoids damage caused by potential temperature fluctuation. The alarm system uses the temperature data to send alerts in case of temperature breaches.

4. Air Circulation

A good airflow is also an important aspect in the storage area to keep a consistent temperature and protect the sensitive material from any spoilage or getting affected by the potential temperature deviation. That said, this further helps prevent condensation and freezer burn or excessive drying of stored products. The air circulation system consists of carefully placed vents and ducts that prevent warm zones from forming inside the rooms.

5. Humidity Control

Another key aspect of cold storage in pharmaceuticals that you need to keep in mind is regulating humidity inside the storage area, and it should be below 65% for most pharmaceutical products. This is because the stored temperature-sensitive products are highly sensitive to moisture. That said, Modern cold storage should be equipped with computerized monitoring according to good storage practice(GSP). 

6. Data Logger and Monitoring System

Similar to the humidity control technique, another condition for efficient cold storage is studying temperature data of cold storage in the storage area. The data logger consistently tracks the temperature and humidity levels to create a historical event for auditing. All these records are stored under the relevant regulatory standards. These data are essential to find out the issues and act accordingly.

7. Backup Power Source

Aside from having a good data logger, it is also crucial to add great backups such as generators, inverters, or UPS into your cold storage facilities. They help in uninterrupted temperature control in the event of a power outage. Thus, if you put the proper backup plan in place, it minimizes the risk of temperature swings that make products ineffective and even dangerous to use.

Cold Storage Manufacturer In Nepal

After knowing all the importance and conditions for cold storage in pharmaceuticals, you might be wondering what is the best cold storage manufacturer in Nepal. Look no further than Nepcool. As a leading cold storage manufacturer in Nepal, Nepcool offers you the best cold storage room and refrigerator transportation system

Since our establishment, we have aimed to deliver customers with eco-friendly and long-lasting refrigeration equipment to meet your unique pharmaceutical needs. If you are still looking for a cold storage room, refrigeration equipment, or refrigerated transportation at an affordable; contact Nepcool. We take pride in manufacturing superior refrigeration across Nepal.

Conclusion 

In conclusion, the utilization of the cold storage room offers various advantages, including extending the shelf life of the pharmaceuticals and providing a cost-effective storage solution. Investing in the cold storage room in pharmaceuticals is the best decision that your organization can make. Safeguarding public health and adhering to regulatory standards are the other benefits of the cold room.  

In this blog, we discussed the role of cold storage in pharmaceuticals, the types of cold storage, the conditions required for it, and the best cold manufacturer in Nepal. We hope you find this helpful. If you seek further insight into the other aspects of cold storage, check out some of our other blogs. Thank you for reading till the end.

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FAQs on Cold Storage in Pharmaceuticals

1. What is cold storage in the pharmaceutical industry?    

Cold storage is a specialized facility built to maintain strong perishable items, including pharmaceuticals, for a longer time. These cold rooms prevent the spoilage of temperature-sensitive medicinal supplies by consistently maintaining low temperatures according to the needs.

2. What devices are used for cold storage in pharmacies?

The cold storage uses several devices to maintain the required temperature range for preserving medicinal supplies. Some of the devices that are used for cold storage in pharmacies include.

  • Ultra low-temperature freezers
  • Medical grade freezers
  • Temperature monitoring systems
  • Alarm systems
  • Cryogenic freezers
  • Thermostats or temperature controllers

3. How does using cold storage help the healthcare industry? 

Cold storage helps the healthcare industry by maintaining precise temperatures necessary for the storage of temperature-sensitive pharmaceuticals, drugs, and vaccines. Commercial cold storage not only ensures the safety of health but also enhances the overall operation. You may fail to adhere to the necessary storage environment guidelines, with no proper cold storage. 

4. What is room temperature in pharmaceuticals?

The specific temperature depends on the needs and requirements of the pharmaceutical business. However, in general, cold rooms typically maintain a temperature range between 15 °C and 25 °C(59°F and 77°F), and they are considered the most suitable for the pharmaceutical industry. 

5. What are the storage conditions for pharmaceutical products?

Pharmaceutical products need to be stored in an area that maintains a stable low temperature and is away from sunlight. Some other storage conditions for pharmaceutical products include.

  • The optimal storage temperature for most pharmaceuticals ranges from 15°C to 25°C(59°F to 77°F).
  • The humidity level should not exceed 60%.
  • Avoiding intense light and strong odors.

6. What are the challenges in managing pharmaceutical cold chains?

The pharmaceutical cold chain is a sequence of storage and distribution activities that maintain a low-temperature range from production to consumption. There are a variety of challenges in managing pharmaceutical cold chains, which are as follows.

  • Damage in cooler or freezer door.
  • Growth of microbes and pathogens within the freezer.
  • Prolonged exposure to excessive heat
  • Spoiled goods or physical damage of product during the storage