• List of the questions, which should be regard at the developing united standards of Cold Chain.
• How to organize the real temperature mode control of the bulk quantity of temperature-unstable immune-biological medications delivered against the Contracts
• List of the main “Cold Chain” principles that should be used in Delivery Contract of temperature-unstable immune-biological medications (hereinafter referred to as medications).
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Recommendations on thermo-containers and temperature control (of optimal temperature modes) devices application, guaranteed the quality maintenance of all kinds of thermal-unstable products/substances at all stages of storage and transportation.
1. Do not use thermo-containers that do not have the Operation and maintenance manuals with recommendations on maintenance of cold duration, warranty, address details and Manufacturer.
2. Do not use thermo-containers, thermo-indicators and thermo-registers if there are not such documents as:
• Conformity of technical characteristics pointed in the Operation and maintenance manuals with the results of testing in laboratories authorized by World Health Organization (WHO) or National Ministry of Health;
• Presence or absence of radioactive, chemical or others substances in the concentration that are permissible to the materials for the thermo-containers manufacture (for safety work of maintenance staff and production, transported in thermo-containers);
• Permission on usage in medical practice given by Ministry of Health of the client’s territory or given by WHO.
3. To protect production from the impact of contact with the frozen cooling elements and improve the air circulations in the thermo-container use the thermo-insulator with the through holes on the all borders.
4. To maintain the optimal safety temperature modes inside the thermo-container use only these cooling elements that are recommended thermo-container’s Manufacturer (same Manufacturer and at the recommended quantity).
5. Do not use the dry ice for products cooling (that should not to be frozen).
6. To maintain the temperature up to 2°C in the thermo-containers load the cooling elements and cooling products/substances at the room temperature, comply with the Manufacturer recommendations.
7. To maintain the temperature mode up to 0°C inside the thermo-container, products/substances should be loaded in the cooling rooms.
8. To temperature mode (2-8)°C control use the thermo-indicators, which allow to evaluate the smooth temperature changing outside that temperature mode to the rates, when products loss quality partially or fully.
9. The thermo-containers to the products/substances that are delivered to the one address should be bundle with the thermo-indicators, thermo-registers, which provide the documentary confirmed information about the maintenance of optimal safety temperature modes from the moment of products are in the store till the moment of its transfer to the ultimate users. The optimal information content, that are given with the help of thermo-indicators or thermo-registers in real time and calendar mode about the absence of violations is:
• LED-light indication about violations of upper or lower limits of controlled temperature mode;
• Duration of temperature violations;
• The rate of maximum or minimal temperature inside the thermo-container during the whole time of control;
• Total duration of results of temperature registration inside the thermo-containers after “turning on” the thermo-indicator or thermo-register and after closing the thermo-container’s covers;
• Print version of registration results in the shape of graphs and “time-temperature” tables that were got through the connection PC with the thermo-indicators or thermo-registers or through the satellite communication or cell communication.
Termo-Kont MK Llc. A. Ushakov
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