Policy bills and performance standards related to medical incubators
The new version of the "Pharmaceutical Business Quality Management Code" issued by the drug supervision department clearly requires that the temperature and humidity automatic monitoring system should be equipped in the warehouse for storing drugs and the equipment for transporting refrigerated and frozen drugs to monitor the temperature and humidity conditions of the drug storage process. Real-time automatic monitoring and recording.
In the actual cold chain logistics process, third-party logistics has been able to meet the requirements of the entire refrigerated transportation in the first-tier cities, but in the second and third-tier cities, there is still the problem of the last mile. In addition to the cold chain monitoring system, it also The cold chain incubator is needed. On the one hand, the number of refrigerated vehicles is insufficient, and the thermal insulation performance of the medical incubator should be more stable and reliable on the other. Let's analyze the insulation performance and standards of medical incubators on related policies.
Medical incubator related policies and regulations. The
main test methods and standards involved in the thermal insulation performance test of medical incubator include: ASTMD3103 "Standard Test Method for Thermal Insulation Performance of Transport Packages", ISTA 7D "Transportation Packaging Temperature Test", ISTA 7E "Packages" "Temperature Testing of Transport Packaging in Transport Logistics", GSP "The Best Management Practice for Drug Operation Quality", "General Specification for Medicine and Medicine Incubators" and other corporate standards.
Among them, in accordance with the GSP "The Best Management Practices for Pharmaceutical Business Quality", the enterprise should equip the temperature and humidity automatic monitoring system (hereinafter referred to as the system) in the warehouse for storing drugs and the equipment for transporting refrigerated and frozen drugs. The system should automatically monitor and record the temperature and humidity conditions during the drug storage process and the temperature conditions during refrigerated and frozen drug transportation in real time to effectively prevent possible risks that may affect drug quality and safety during storage and transportation, and ensure drug quality and safety. The medical incubator is used in the transportation of medicines, and the specific requirements are as follows.
The three key requirements for the incubator in the new version of GSP
①The incubator should have good insulation performance; the incubator should have the function of automatically regulating the temperature, and the incubator should be equipped with cold storage agents and a device for isolation from medicines.
② During the transportation of refrigerated and frozen drugs, the temperature data in the refrigerated truck, refrigerated container or incubator shall be collected, recorded, and transmitted in real time. When the temperature exceeds the specified range during transportation, the temperature and humidity automatic monitoring system shall issue an alarm command in real time, and the relevant personnel shall find out the cause and take effective measures to regulate and control in time.
③If refrigerated containers and incubators are used to transport refrigerated medicines, the medicine packaging and boxing operations shall be carried out in accordance with the verified standard operating procedures.
The functional characteristics and communication method of medical incubator
The incubator is relatively small in size, free of space constraints, and can be transported to the destination by various means of transportation, which greatly reduces transportation costs. At the same time, the incubator also has the two major characteristics of "long-term temperature control" and "small and light", and has a long heat preservation time. Even in areas with relatively backward infrastructure, it can also give full play to its advantages of "mobile small cold storage".
GPRS wireless communication method:
If the transportation service network is not developed enough, you can also choose to install a GPRS data card. Domestic GPRS has achieved nationwide coverage. As long as you can make a call, you can use GPRS to upload data in real time, ensuring that the staff can remotely monitor the temperature in the incubator, and ensure the safety and efficiency of vaccine transportation.
Function: The manager can remotely monitor the real-time temperature in the incubator through the medical monitoring software to ensure that the temperature of the medicine is always kept within a safe range.
Significance: Realize more real-time and accurate detection of temperature and humidity of medicines, save a lot of manpower and material resources, greatly improve management efficiency, and ensure the safety of medicines.
In summary, the application of cold chain incubators in the cold chain industry has been widespread, under the requirements of the new version of GSP. The overall packaging design of the medical cold chain incubator still needs to further improve some specific and effective methods of standardization and inspection. To ensure the effectiveness and safety of drugs in the cold chain logistics process.