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Policy bills and performance standards related to medical incubators

by:Rika Sensors     2021-12-13
Policy bills and performance standards related to medical incubators
The new version of the 'Pharmaceutical Management Standards' promulgated 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 of the drug storage process. The humidity status is automatically monitored and recorded in real time.

In the actual cold chain logistics process, third-party logistics has been able to meet the requirements of full refrigerated transportation in the first-tier cities, but in the second and third-tier cities, there is still a problem of the last mile, except for cold chain monitoring. In addition to the system, a cold chain incubator is also needed. On the one hand, the number of refrigerated vehicles is insufficient, and on the other, the thermal insulation performance of the medical incubator should be more stable and reliable. Let's analyze the insulation performance and standards of medical incubators on related policies.

Policies and bills related to medical incubators

The main test methods and standards involved in the thermal insulation performance test of standard medical incubators include: ASTMD3103 'Standard Test Method for Thermal Insulation Performance of Transport PackagesTemperature Test

Among them, in accordance with the GSP 'The Best Management Practices for Drug Operation QualityThe system should conduct real-time automatic monitoring and recording of the temperature and humidity conditions during the drug storage process and the temperature conditions during the refrigerated and frozen drug transportation process to effectively prevent possible risks that may affect the quality and safety of the drug during the storage and transportation process, and ensure the quality and safety of the drug. The medical incubator is used in the transportation of medicines, and the specific requirements are as follows.

Three key requirements for the incubator in the new version of GSP

①The incubator should have good thermal insulation performance; the incubator should have the function of automatically regulating temperature, and the incubator should be equipped with cold storage agent and isolated from medicines. s installation.

② During the transportation of refrigerated and frozen medicines, the temperature data in the refrigerated truck, refrigerated container or incubator should be collected, recorded, and transmitted in real time. During transportation, when the temperature exceeds the specified range, 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.

Functional features and communication methods of medical incubators

The incubators are relatively small in size 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 characteristics of 'long-term temperature control' and 'small and light

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: Managers 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.

To sum up, 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.

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