Welcome to the Coreco Medical Lab blog. One of the main challenges we face in medical refrigeration is how to preserve heat-sensitive products.
In this article, we want to highlight some of the key features that this equipment must have to ensure the preservation of heat-sensitive products and that Coreco Medical Lab already incorporates them into its own.
Thermally unstable pharmaceutical products are defined as all products that require constant cold storage at product-specific temperatures below room temperature.
This also includes vaccines that are normally stored at temperatures between 2 °C and no higher than 8 °C and that, of course, require a constant and very specific cold chain, as we are seeing with some of those used for COVID-19.
Storage, supply, and distribution are the three components of supply chain management for heat-sensitive pharmaceutical products.
All pharmacists are responsible for the effective, efficient, and safe handling, storage, and distribution of these products.
Basic Handling Processes
The DIN 58345 standard establishes the appropriate measures for fulfilling the responsibility to preserve heat-sensitive products. At the following link, you can view an infographic on Storage and Preservation of Medications and Medical Devices in Healthcare Facilities
The handling and storage of heat-sensitive pharmaceutical products must comply with the procedures designed and established to prevent any type of contamination, deterioration of the goods, damage to packaging, and/or product mix-ups.
Essential Care
Special care must be taken to maintain the integrity of the ingredients and seals on the packages. It is necessary to follow the manufacturer's instructions regarding the handling or storage of the goods.
Another essential aspect is monitoring the distribution systems chosen to deliver heat-sensitive pharmaceutical products from the manufacturer/importer to the end customer.
Anyone in the supply chain must take into account basic operational parameters, including on-time delivery and accountability.
Importers must take all necessary measures to ensure that heat-sensitive pharmaceutical products are not mishandled or exposed to adverse storage conditions at ports of entry.
The Importance of Storage Areas
Storage areas for heat-sensitive products may include, among other equipment: cold storage rooms, refrigerators, and freezers.
Heat-sensitive pharmaceutical products require temperature-controlled storage and, therefore, must be identified upon receipt and stored in accordance with the instructions.
The Right Temperature
Temperatures must be monitored and recorded twice a day. These records must be reviewed regularly. Temperature-controlled storage areas must be equipped with temperature loggers.
The control system must be adequate to keep the entire product within the specified temperature range at all times. This control is essential for maintaining the quality of heat-sensitive pharmaceutical products until final delivery. In this way, we prevent poor control from causing the products to arrive in substandard condition or, worse yet, to be ineffective in treating patients.
Storage and Control of Heat-Sensitive Products
- Heat-sensitive pharmaceutical products must be stored in a temperature-controlled environment in accordance with the information on the manufacturer's product label, which specifies the temperature at which the product must be kept at all times. This is typically a cold storage room.
- The storage area must be large enough to allow for the orderly arrangement of products, to ensure proper air circulation—especially between the shelves—and to facilitate product rotation. If the area is filled to capacity, the effect on temperature distribution must be closely monitored.
- The storage area must be kept clean. The internal air temperature distribution must be mapped within the storage area, both when it is empty and when it is fully stocked. Heat-sensitive pharmaceutical products must not be stored in areas where the temperature could pose a risk to the products’ stability (for example, in the unit’s cooling airflow).
- All storage areas used to store heat-sensitive products, such as pharmacy refrigerators or cold storage rooms must be maintained regularly and operated in accordance with the manufacturer's instructions to ensure optimal performance.
- Condensation from refrigerators should not be collected inside the storage area because it can accumulate or drip onto the products.
- An adequate number of temperature-monitoring devices must be installed to provide not only temperature data but also a temperature map of the storage area.
- Temperatures must be monitored and recorded at least twice a day, with an interval of at least seven hours, and the monitoring records must be reviewed daily.
- Large commercial refrigerators and walk-in cold storage rooms must be monitored using an electronic temperature-recording device that measures the temperature of the cargo at one or more locations, depending on the size of the unit.
- Portable data loggers that can be downloaded to a computer can be used to monitor large commercial refrigerators and walk-in cold storage rooms.
- The refrigerator, cold storage room, or freezer must be connected to a backup generator or other emergency power system to ensure an uninterrupted power supply in the event of a power outage.
- The refrigerator, cold storage room, or freezer must be connected to an alarm system and/or an alert system in the event of a power outage or if the temperature limits in the storage area are exceeded.
- Every recording device or instrument must be calibrated annually against a certified standard.
- The refrigerator, cold storage room, or freezer must be clearly labeled and properly signed to store only heat-sensitive pharmaceutical products.
Storage in Pharmacies and Health Centers
- Inside pharmacies, the storage area for heat-sensitive products must be easily accessible to the pharmacist. Care must also be taken to ensure that it is not exposed to direct sunlight and that the refrigerator is placed at least 15 cm away from the wall.
- Within a health center, any storage area for heat-sensitive pharmaceutical products must be easily accessible to authorized healthcare professionals and must follow the same guidelines as above.
What solutions does Coreco Medical Lab offer for the storage of heat-sensitive products?
Coreco, a company specializing in industrial refrigeration, offers a range of solutions for the preservation of heat-sensitive products through its MedicalLab division.
Specifically for temperature control and monitoring, we offer
- Advanced temperature and alarm management, in accordance with regulations for the storage of medications and vaccines, featuring audible and visual alarms in the event of temperature deviations, an open-door alarm, a sensor failure, or high condensation temperature.
- Connection port for external alarms and a probe with product simulation for better management of the refrigeration unit's operation.
- EN58345 safety thermostat (standard for vaccines and optional for the laboratory) prevents the temperature from dropping to the freezing point of the heat-sensitive substance.
- Battery with EN58345 charger (standard for vaccines and optional for the laboratory), which will enable the digital control unit to operate autonomously, continuing to manage temperature and alarm settings.
- Displays with IP65-rated protection.
- Local or remote connectivity for temperature monitoring and alarms.
- Optional: Data logger, with access via Bluetooth or Wi-Fi, HACCP data recording, viewable on screen and downloadable via USB port in CSV format (graphical display only).
- Wi-Fi or Bluetooth interface, allowing you to view alarms and temperatures and access configuration settings from a PC, smartphone, or tablet.
- IoT communication interfaces comply with cybersecurity requirements for network-connected products, as well as those specific to medical and healthcare systems
We hope you found the article on how to store heat-sensitive products useful. More content will be coming soon to our blog. Best regards, and see you next time.
