Welcome to the Coreco Medical Lab blog. In this case it will be explained how to preserve thermolabile products. For this, the article shows some of the main characteristics that the laboratory fridge must bring together to ensure the preservation of thermolabile products. Coreco Medical Lab has already incorporated it in their lab refrigerators.
Thermolabile pharmaceuticals are defined as all products requiring constant cold storage below room temperature. This also includes vaccines that are normally stored between 2ºC, they do not exceed 8ºC. They need a constant, special cold chain.
Storage and distribution are the 2 parts of the supply chain management of thermolabile pharmaceuticals. All pharmacists are responsible for the effective, efficient and safe handling, storage and distribution of these products.
Basic processes of manipulation
DIN 58345 establishes the appropriate measures to comply with the responsibility of preserving thermolabile products. In the following link, it is possible to find an infographic on storage of medicines and medical devices in health care units.
The handling and storage of thermolabile pharmaceuticals must be in accordance with procedures designed and established to prevent any contamination, deterioration of goods, damage to packaging and/or confusion of products.
Essential care to preserve thermolabile products
Special care should be taken to maintain the integrity of the ingredients and seals on the packages. It is necessary to pay attention to the manufacturer’s instructions.
Another essential part is to keep a watchful eye on the distribution systems chosen to deliver thermolabile pharmaceuticals from the manufacturer/importer to the final customer.
Anyone in the supply chain must take into account basic operational parameters, including timeliness and accountability.
Importers should take all necessary measures to ensure that thermolabile pharmaceuticals are not mishandled or exposed to adverse storage conditions within ports of entry.
Importance of storage areas
Storage areas for thermolabile products may include, but are not limited to: cold rooms, refrigerators and freezers.
Thermolabile pharmaceuticals require controlled temperature storage. Therefore, they must be identified upon receipt and stored in accordance with the instructions.
The right temperature
Temperatures should be monitored and recorded twice daily. These records should be checked regularly. Temperature controlled storage areas must be equipped with temperature recorders.
The control must be adequate to keep the entire product permanently within the specified temperature range. This control is essential to maintain the quality of thermolabile pharmaceuticals until final delivery. In this way we avoid that by a bad control, the products arrive with an inferior quality or, what would be worse, ineffective to cure.
Storage and control of thermolabile products
• Thermolabile pharmaceuticals should be stored in a temperature-regulated environment, according to the information on the manufacturer’s product label.
• The storage area should be large enough to allow the orderly arrangement of products and to allow air circulation, especially between the shelves and for product rotation. If it is fully filled, the effect on temperature distribution should be frequently controlled.
• The storage area must be kept clean. The distribution of the internal temperature of the air must be mapped in the installation of the storage area, both in vacuum and when it is completely full. Thermolabile pharmaceuticals should not be stored in areas where temperature may suffer a risk to product preservation (for example, in the cooling air flow of the unit).
• All storage areas, which serve to preserve heat-labile products, such as refrigerators or cold stores, must be continuously maintained and must follow the manufacturer’s standards for optimal operation.
• Condensation from refrigerators should not be collected within the storage area because it can accumulate or drip onto products.
• An adequate number of temperature control devices should be installed to provide, not only temperature information, but also a temperature map of the storage area.
• Temperatures should be monitored and recorded at least twice a day, with an interval of at least seven hours, and monitoring records should be reviewed daily.
• In the surveillance of large commercial refrigerators, portable data loggers can be used in a computer.
• The refrigerator or freezer must be connected to a backup generator or other emergency power system to ensure uninterrupted power supply in the event of power failure.
Storage in Pharmacies and Health Centres
• Within pharmacies, the storage area for thermolabile products must be easily accessible to the pharmacist. It is also necessary to ensure that it does not receive direct sunlight and that the refrigerator can be separated at least 15cm from the wall.
• Within a Health Centre, any storage area for thermolabile pharmaceuticals must be easily accessible to licensed health professionals and with the same advice above.
What solutions does Coreco Medical Lab have for the preservation of thermolabile products?
Coreco, as a company specialized in industrial cold, provides a series of solutions to the conservation of thermolabile products through its division MedicalLab.
Specifically for temperature control and monitoring,
• Advanced temperature and alarm management, according to medicines and vaccines conservation regulations, with acoustic and visual alarms in case of temperature deviation, open door alarm or probe failure, and high condensation temperature.
• Contact for external alarm connection to the equipment.
• Safety thermostat EN58345 (standard for vaccines and optional for laboratory), prevents the temperature drop to the freezing point of the thermolabile.
• Battery with charger EN58345 (standard for vaccines and optional for laboratory), which will allow the autonomous operation of the digital control, which will continue to manage temperature and alarm values.
• Screens, with protection grade IP65.
• Local or remote connectivity for temperature monitoring and alarms.
• Optional: Data logger data logging, with access via Bluetooth or Wi-Fi network, HACCP data recording, viewable on screen and downloadable by USB port in CSV format (only on graphic device).
• Wi-Fi or Bluetooth interface, allows viewing alarms, temperatures and access configuration operations from PC, smartphone or tablet.
• IoT communication interfaces, with cybersecurity requirements for network-connected products as well as those specific to medical and healthcare systems
We hope this article about how to preserve thermolabile products is useful for all of you. Soon more content on our blog. A greeting and until the next.
