Importance of Cold Storage in the Pharmaceutical Industry

Pharmaceutical businesses are in the business of helping people live longer and healthier lives. 

They wish to help as many people as possible by providing the greatest medication at the best price. To do so, they must protect their products from extremes of heat and cold.

For a variety of reasons, cold storage is an important aspect of pharmaceutical businesses’ supply chain management.

It saves them money and time by lowering the number of refrigeration units required in each distribution center. 

It also helps them save money on energy by minimizing fuel consumption and greenhouse gas emissions from refrigeration units by using more effective transportation routes and carrying less freight.

When storing medications, you must ensure that they are kept at the proper temperature. 

This is particularly essential because medications might lose their efficacy when exposed to severe temperatures.

As a result, it’s preferable to avoid placing heat sources near the medications and to keep the ambient temperature as consistent as possible. 

In addition to these things, having a temperature data logger in the room to monitor the temperature is a good idea.

1. A Wide Range of Applications:

Additional applications for pharmaceutical cold storage should be studied. 

Storage units can be customized to fit a wide range of products that require temperature control. 

Cold units can assist maintain the integrity of any sensitive material you keep within, from pharmaceuticals and vaccinations to delicate biological samples. 

The requirement of cold storage is from the API industry ie for storage of raw material to finished goods and also Injectable/Vaccine manufacturing companies for storage of intermediate/ finished goods. 

Even it becomes very vital for the cold supply chain where the temperature of the product is to be maintained from Manufacturing to transportation to C&F facilities for distribution.

These units are also designed to avoid unwelcome swings, resulting in a more stable storage environment and a lesser risk of compromise. This can aid in increasing efficiency and reducing product waste in general.

2. Unused Area:

Cold storage solutions come in a variety of shapes and sizes to suit the demands of organizations with limited space. 

One advantage is that depending on how much space you have in your structure, units can be used interior or outdoors. 

These units can also be used as backups or long-term storage for items that aren’t needed right away

3. Energy-conserving:

Pharmaceutical cold storage units are also extremely energy-efficient, which can assist cut down on the costs of storing samples using other methods. 

This is due not only to their design but also to the fact that they are built to limit temperature variations, thus they are less likely to waste energy balancing temperatures while in operation.

The temperature has an impact on the stability of therapeutic ingredients. Temperature-sensitive materials can degrade at higher temperatures, thus it’s critical to monitor the storage location’s temperature.

Vaccines and medicines, for example, must be stored at constant temperatures to be safe. Temperature changes can make objects unstable, reducing their effectiveness and making them risky to use. As a result of these issues, there is more waste, which can have major cost effects.

Temperature readings should be accurate. Temperature and percentage errors should not exceed +0.2° and +3%, respectively. 

The use of thermocouples or data recorders can be used to monitor the region. Any software used to gather data must be validated and meet the criteria of 21 CFR Part 11.

This emphasizes the significance of precise temperature mapping in the pharmaceutical industry. 

Drug companies must work to ensure that their products are as effective as possible. Failure to do so may result in customer harm and income loss. This is true for both prescription and non-prescription drugs.

For example, if a customer’s daily vitamin isn’t as potent as it should be, there’s little risk. However, mortality can occur if insulin, asthma, or cardiac drugs are no longer effective.

Instructions for proper storage are included on all drug labels. 

If the drug’s chemistry and substances become too hot or cold, they may change. Chemotherapy treatments, antibiotics, contraceptives, and seizure meds are all common examples.

The April 2019 rules from the United States Pharmacopeia (USP) address medicine storage and shipment. It specifies the temperature ranges that are permitted for various refrigeration classifications.

• The temperature ranges from -25° to 10°C in the freezer.
• Between 20° and 25°C is the ideal controlled room temperature.
• Temperatures should be kept between 8° and 15°C in cool storage.
• The temperature is kept between 2° and 8°C in refrigerated storage.
• The temperature in the room runs from 20° to 25°C, with outer limits of 15° to 30°C.

Consumers are also advised to “keep medicine in a cool, dry area” or “guard from light” according to the labels. This also addresses the product’s light and humidity sensitivity.

The FDA’s compliance rule is the Current Good Manufacturing Practice (cGMP). 

Its principal goal is to ensure that drug items are manufactured to the highest possible standard. To protect the public, the FDA keeps a careful eye on drug corporations.

Pharmaceutical enterprises must make use of the most up-to-date systems and technologies. The regulation establishes minimum criteria for each stage of the manufacturing process. 

This covers all manufacturing, processing, and packaging controls, procedures, and facilities.

The cGMP establishes high standards and is legally binding. These regulations aim to ensure that clients obtain pharmaceuticals that are pure, safe, and effective.

Drug companies produce millions of medications each year. Testing can only be done on a small percentage of the product because it damages it. 

Strict testing aids in ensuring uniformity from batch to batch.

1. Identify the Location:

Make a list of all the equipment and places that are involved. Make a list to ensure that each step of the process is thoroughly tested.

According to USP requirements, each item on the list must be tested for at least 24 hours. Be aware that certain items may require more frequent testing in order to comply with requirements.

Purchasing your own monitoring equipment may be advantageous. When the temperature falls outside of the pre-set range, some monitors sound an alarm.

2. Determine Number of Sensors and its Placement:

Then, in certain spots, place sensors. Depending on the equipment or space, you can employ a variety of sensors. Here are a few examples:

• Temperature sensors that have been pre-calibrated
• Temperature sensing devices
• Sensors that keep track of temperature and other data

It is critical that all testing be accompanied by thorough documentation. The use of data-logging sensors aids in the completion of this task.

The number of sensors used in temperature mapping is a perplexing problem for pharmaceutical professionals because most regulatory rules do not specify how many sensors should be utilized. 

Temperature mapping should be done with a sufficient number of sensors, according to USP.

However, the International Society for Pharmaceutical Engineering recommends that for areas less than 2㎥, nine sensors be used. There should be one in each corner and one in the center of the room. 

If the area’s volume is between 2㎥ and 20㎥, 15 sensors should be utilized to map it. 

9 sensors should be arranged in a 9 sensor layout, with extra sensors positioned in the middle of the floor, ceiling, and walls.

Additional sensors should be utilized if the area is larger than 20㎥ and the criticality of the area is understood. 

Between the wall and the sensors, a certain gap should be maintained. Before beginning the mapping, all sensors must be calibrated and traceable to NIST.

3. Frequency of Mapping

In any GMP storage facility, the mapping should be done twice a year on the coldest and hottest days of the year. 

At this point, the hotspot should locate the mapping and perform standard temperature mapping.

4. Document Uniform Test Results

It is clear that it’s crucial to put your pre-calibrated sensors in the right places in your equipment or confined environments. 

Different portions of a space may be warmer or cooler due to exposure to windows or doors.

HVAC systems have an impact on the airflow in a room and can change the temperature. 

Even being close to an outside wall causes the room to become colder or hotter in that area.

Consider doing the study during multiple seasons when mapping a facility or warehouse. For instance, during the dry, hot summer and the damp, freezing winter.

This proves that the temperature in your space remains constant. Make sure to do the same for all modes of transportation.

5. Measure Temperature Recovery Time

Defrost cycles are performed on most equipment on a regular basis. The temperature is also changed by opening and closing the door. Always check how long a storage unit takes to return to the proper temperature range.

6. Maintenance and Calibration of Equipment

After you’ve finished the mapping research, re-calibrate all of the sensors you used and keep track of the results. This proves the validity of your research.

Establish a maintenance and calibration schedule for the equipment. This involves ensuring that monitoring equipment is calibrated to NIST, ISO17025, or international standards.

When purchasing new equipment, request a calibration certificate from the company. It’s also a good idea to do your own calibration.

All these disciplines must meet strict regulatory compliance. This article described the rationale and method for pharmaceutical temperature mapping.

Aquamech designs, and provides complete turnkey solutions to set up Cold storage facilities which include data logging as per CFR21 Part 11 and all documentation provided to comply with any audit authorities.

CFR21 part 11 would include Audit trails, trending, and reporting as per each company policy and requirements. We can discuss SCADA CFR 21 Part 11 requirements in detail and complete solutions can be provided.

We have refrigeration solutions from Air-cooled to Water-cooled units and also RACK units for power conservation and to provide rooms for positive and negative temperatures.

In Insulated panels, we have solutions from Polyurethane Foam(PUF), Polyisocyanurate (PIR) which can be FM or non-FM-approved, and Rockwool for fire retardant for 2 hours.

Indoors we have solutions from Motorised sliding doors, swing doors, High-Speed motorized doors, Overhead doors, and Docklevers.

We do provide automation with CCTV cameras inside the room and also motion detectors can be installed for the safety of the persons inside the room and to conserve power for the lights.

We can provide remote monitoring systems, and SMS  solutions to engineering and maintenance staff to report any abnormality in the functioning of the cold storage facility. 

Contact us at coldsales@aquamech.co.in  or message our design head Navdeep Singh Sethi today to learn more about our products and services.