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General Requirements For Pharmaceutical Cold Chain Insulation Boxes

December 3, 2019

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In the "General Specifications for Pharmaceutical Cold Chain Incubator", the medicine cold chain incubator is defined as the collective name of cold storage boxes used for loading refrigerated drugs and controlling and monitoring their temperature during logistics during the transportation of refrigerated drugs. It consists of 3 parts: cold and heat medium (refrigerant), incubator body and temperature monitoring equipment. At the same time, specific requirements are put forward for the performance of these three parts. The Transportation Insulated Box Supplier will be introduced in detail below.


1. Coolant performance of ice pack and ice box

(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: After freezing, the volume of the outer packaging increases by less than 12%, and the local bulge is less than 15%.

(3) Phase transition temperature: after freezing, the volume of the outer package increases by less than 12%, and the local bulge is less than 15%.

(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, and the deviation is not greater than ± 3%.

(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.


2. Insulation box body performance

(1) Dimensions: Measure the external dimensions of the Medication Travel Cooler Pack using a verified measurement tool.

(2) Impact resistance

(3) Compression resistance: The cabinet is subjected to a pressure of 5000Pa.

(4) Dust and water resistance

(5) Load-carrying performance: Carry the cargo with the maximum load (including refrigerant) in the box, and suspend the box from the handle or handle of the box for 1 hour.

(6) Thermal insulation performance: The operation steps of the thermal insulation test are as follows: pre-cool the refrigerated medicine or simulant and the test object (cold-chain incubator) to the storage temperature required by the product; Or the simulants are placed in the pre-cooled test object (cold-chain incubator); 5 temperature recorders are placed at the center, upper and lower sides, and two adjacent sides of the product substitute package, respectively; The cold storage agent is placed around the product in the box, and at the top and bottom positions. The cold storage agent is isolated from the product substitute and the temperature recorder through a temperature isolation device. Cover the cold chain insulation box cover, move the box to the test environment space where the temperature recorder is placed, and set the test time. After stopping the test, take out the temperature recorder in the cold chain incubator and the temperature recorder in the test space. Read the temperature data to see if the ambient temperature and the temperature inside the product meet the verification indicators. This operation is especially important for Cool Box for Vaccine Transport.



Cool Box for Vaccine Transport


Cool Box for Vaccine Transport


3. Technical requirements for incubator monitoring

In the "General Specification for Pharmaceutical Cold Chain Insulation Boxes", only temperature monitoring equipment is required, but in the actual application process, higher monitoring requirements are required. The specific content is as follows:

(1) When refrigerated transportation, medicines must be equipped with an automatic temperature and humidity monitoring system. The system should automatically generate temperature and humidity monitoring records. Temperature, humidity, time, and location of the measuring points and other systems must be true, complete and accurate Is valid and cannot be changed.

(2) The incubator shall be equipped with at least one measuring terminal.

(3) The system shall continuously monitor and record the temperature and humidity environment during the storage and transportation of medicines.

(4) The alarm methods of the temperature and humidity automatic monitoring system include local alarm (sound and light alarm) and remote alarm to notify at least 3 people.

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