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Standard For Pharmaceutical Cold Chain Insulation Box

June 29, 2020

Latest company news about Standard For Pharmaceutical Cold Chain Insulation Box

At present, in the field of pharmaceutical cold chain logistics, mobile refrigeration, refrigeration box insulation and monitoring, pharmaceutical refrigeration packaging, dedicated refrigeration media, and unitized refrigerators are widely used. In order to meet market demand, the Internet of Things technology has also been introduced. RFID technology, temperature sensor technology, GPS technology, wireless communication technology, etc. carry out real-time monitoring of the quality of refrigerated medicines during transportation, transparent management and full traceability. What are the test methods and standards for the thermal insulation performance of medical cold chain insulation boxes? Suppliers of Lunch Ice Packs will come to tell you.


Cold chain transportation of refrigerated medicines has higher requirements for logistics distribution. At present, many developed countries have basically formed a complete cold chain logistics system. We can refer to the experience and practices of developed countries in cold chain logistics to learn and establish a cold chain logistics system suitable for China.


What are the current insulation test methods and standards for pharmaceutical cold chain insulation boxes? The new version of GSP requires uninterrupted cold chain control and management. The so-called uninterrupted cold chain control means that the cold chain control is implemented throughout the drug storage, delivery, transportation, storage, and sales processes, and complete records are required. Generally, pharmaceutical manufacturers and operating companies use special cold chain facilities and processes to ensure the cold chain temperature of the above links. Common cold chain equipment includes cold storage, Medication Travel Cooler Pack, refrigerated trucks, freezers, etc. Validation of these cold chain facilities is a basic prerequisite to ensure that cold chain medicines can always meet temperature control requirements.

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Medication Travel Cooler Pack


The key requirements of the new version of the GSP on the incubator: the refrigerated box and the incubator have good thermal insulation performance; the refrigerated box has the function of automatically adjusting the temperature; the incubator is equipped with a cold storage agent and a device isolated from the medicine. During the transportation of refrigerated and frozen medicines, the temperature data in the refrigerated truck, refrigerated box or incubator should be collected, recorded and transmitted in real time.


During the entire logistics process of the incubator, the internal temperature data should be collected, recorded, and transmitted in real time. If it exceeds the range, the automatic monitoring system is required to issue real-time alarms to remind relevant personnel to take effective measures in a timely manner to ensure that the drug is in the entire logistics process. Safety and quality. When transporting refrigerated medicines in insulated boxes, packing and packing of medicines should be performed in accordance with verified standard operating procedures. In other words, before carrying out the actual cold chain logistics process, the insulation box needs to strictly verify the operation regulations of its internal medicines, and carry out detailed research on the environmental conditions and personnel of the packing, specifying the specific conditions and The main purpose of restricting the relevant work content of personnel is to ensure the safety of drugs in the entire cold chain logistics process.


Pharmaceutical cold chain insulation box is defined as: a collective name for cold storage boxes used to load refrigerated drugs and control and monitor their temperature during logistics in the transportation of refrigerated drugs, which are mainly composed of cold and heat medium (coolant), the body of the incubator and The temperature monitoring equipment consists of 3 parts. At the same time, specific requirements are put forward for performance.


Cooling Ice Pack

(1) Pressure resistance performance: The ice pack and ice box can withstand external pressure, and the outer packaging is not damaged.

(2) Anti-deformation performance.

(3) Phase transition temperature.

(4) Weight requirements: The actual gross and net weights of the smallest unit of the coolant are consistent with the gross and net weights indicated on the outer packaging of the coolant.

(5) Environmental protection requirements: Refrigerant materials should be safe and non-toxic; if air transportation is adopted, they should meet the relevant requirements for air transportation.


The above is the standard of medical cold chain insulation box, I hope to help everyone.

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