Medical Device Cold Chain Transportation Management System
1. Before cold chain transportation of medical devices, delivery routes should be reasonably arranged. The cold chain transportation of medical devices should be timely, accurate, safe, and economical, and the transportation route should be selected while ensuring safety. When arranging the cold chain transportation route for medical devices, it should be ensured that urgent goods are delivered first, and products that require refrigeration should be prioritized for transportation. When shipping, the delivery personnel verify the unit and product quantity one by one based on the sales list provided by the warehouse keeper, and confirm them clearly.
2. When transporting diagnostic reagents and medical devices, cold chain transportation personnel should first inspect the transportation tool and select a suitable transportation tool based on external weather and product storage temperature requirements. If it is found that the cold chain transportation conditions of medical devices do not meet the regulations, they should not be shipped. During the cold chain transportation process of medical devices, the transportation vehicle should be kept sealed. Attention should be paid to insulation in winter, shade in summer, and moisture prevention in rainy and snowy weather. For cold chain transportation of medical devices with temperature requirements, insulation or cooling measures should be taken based on seasonal temperature and transportation distance. To meet the temperature control requirements for cold chain transportation of medical devices and ensure continuous cold chain operation.
3. Diagnostic reagent transportation product loading: Load the products one by one according to the "sales outbound invoice (accompanying the goods)". The cold chain transportation and loading of medical devices should be carried out according to the distribution route, with long-distance customers loading first and then close customers loading in this order.
4. During the cold chain transportation and loading of medical devices, the handling and stacking of products should strictly follow the requirements of the product's outer packaging diagram for loading and unloading. Handle with care, strictly prohibit falling or touching, and prevent rough loading and unloading.
5. The cold chain transportation of medical devices adopts enclosed transportation tools such as box trucks to prevent product exposure, falling, damage, loss, and pollution by rain and snow. The door of a box truck cannot be sealed, and if the cold chain transportation conditions of medical devices do not meet the regulations, they cannot be shipped.
6. Cold chain products should be transported in a centralized manner. Refrigerated and frozen products should be shipped using refrigerated trucks, refrigerated boxes, insulated boxes, and other methods. The packaging and sealing of refrigerated and frozen products should be completed in a refrigerated environment. Medical device cold chain transportation cold chain operators should undergo cold chain training and be proficient in operation. The type, material, placement method, and insulation capacity of the refrigerant in the insulation box during transportation should be verified. During the cold chain transportation of medical devices, products should not directly come into contact with storage agents such as ice packs and ice packs to prevent any impact on product quality. Before use, the insulation box should be filled with fully stored cold chain materials, such as ice bags, ice rafts, etc., according to the verified results. Only when the temperature inside the box meets the requirements can it be packed. Before loading medical devices for cold chain transportation, the temperature inside the insulation box should be checked. Only those that meet the temperature requirements can be loaded onto the vehicle. The medical device cold chain transportation vehicle refrigerated box should undergo pre cooling treatment according to the verification results before use, and be placed in the refrigeration review area for use after reaching the specified temperature. The pre cooling time of the vehicle mounted refrigeration box and insulation box, as well as the quantity of refrigerant storage placed, should be recorded and traceable; The pre cooling of refrigerated trucks should record the start pre cooling time, temperature reaching time, outdoor temperature status, equipment operation status, etc. Before loading the refrigerated vehicle, it should be ensured that the vehicle can start and operate normally. The pre cooling temperature should be set according to the verification results, and the vehicle should be pre cooled to the specified temperature before loading. The cold chain transportation of medical devices should have a shipping record of refrigerated and frozen products, including the means of transportation, departure time, departure temperature, etc.
7. The equipment for transporting refrigerated and frozen products is equipped with a temperature and humidity monitoring system, which can automatically monitor and record the temperature status during the transportation process of refrigerated and frozen products in real time, effectively preventing various risks that may affect product quality and safety during storage and transportation, and ensuring product quality during storage and transportation. The refrigerated carriage has properties such as rainproof, breathable, non flammable, and corrosion-resistant. There is a space inside the carriage to ensure sufficient circulation of cold air, and drainage holes with good airtightness are set up. The cold chain transportation of diagnostic reagents and medical devices should adopt a safe and reliable method to backup monitoring data on a daily basis. The backup data should be stored in a safe place, and the data should be stored for no less than 5 years. During the cold chain transportation of medical devices, if the temperature exceeds the specified range, the transportation personnel must identify the cause and take effective measures to regulate it in a timely manner.
8. The automatic monitoring of temperature and humidity during the cold chain transportation of medical devices should comply with the provisions of the GSP specifications and related appendices. The refrigerated truck should have the functions of automatically regulating temperature, displaying temperature, storing and reading temperature monitoring data. The refrigeration box and insulation box should have the function of external display and collection of temperature data inside the box. The cold chain transportation of medical devices should be calibrated according to regulations for temperature recording equipment, monitoring and alarm devices, etc., to maintain accuracy and integrity.
9. For transporting refrigerated or frozen products using refrigerated trucks, the following requirements should be followed before shipment: open the refrigeration unit and temperature monitoring equipment in advance, preheat or pre cool the temperature inside the carriage to the specified temperature; Turn off the refrigeration unit when starting loading and complete the product loading as soon as possible; After the product is loaded onto the vehicle, close the compartment door in a timely manner, check the airtightness of the door, and lock it. After the product is packaged, there should be a ventilation distance of no less than 10 centimeters between the product and the front panel in the compartment, and a diversion distance of no less than 5 centimeters between the product and the rear panel, side panel, and bottom plate. The product stacking height should not exceed the lower edge of the refrigeration unit air outlet, and a loading limit line should be drawn inside the compartment to avoid affecting the normal circulation of air flow and the uniform distribution of temperature. The refrigeration box needs to start the refrigeration power supply and temperature monitoring equipment, and the insulation box needs to start the temperature recording equipment. After real-time monitoring and recording of the temperature inside the box, the box should be sealed. If the refrigeration of the refrigerated truck cannot reach the specified temperature, it shall not be shipped. Cold chain tea farmers should have shipping records of refrigerated and frozen products, including transportation tools, departure time, departure temperature, etc.
10. The cold chain transportation of medical devices should have emergency plans and disposal measures for product transportation. The transportation of diagnostic reagents should prevent unexpected events from affecting the quality and safety of products during transportation. Only when safety is ensured can cold chain products be shipped. The emergency plan should be revised in a timely manner based on the actual situation to ensure its effectiveness.
