Basic knowledge about cold chain transportation of medicines！

Pharmaceutical cold chain transportation is a special branch of cold chain transportation. The quality of drugs is directly related to people’s lives and even life safety. Therefore, it is necessary to strictly ensure the quality of drugs in all aspects of drug cold chain transportation, reduce loss, and prevent qualitative changes and pollution. Here we will popularize some knowledge about drug cold chain transportation.

refrigerated medicine

Refers to the medicines that have cold or freezing temperature requirements for storage and transportation conditions.

cold place

Refers to the storage and transportation conditions with a temperature in the range of 2 to 10℃. Unless otherwise specified, biological products should be stored and transported in the dark at 2-8℃.

frozen

Refers to the storage and transportation conditions with a temperature of -2℃ or below.

cold chain

Refers to temperature-sensitive drugs such as refrigerated drugs. The entire storage and distribution process from the finished product warehouse of the manufacturer to the use before use must be in a specified temperature environment to ensure the special supply chain management system of drug quality.

Characteristics of pharmaceutical cold chain

Drug cold chain is a special branch of cold chain transportation. What are the characteristics of drug cold chain transportation?

high quality requirements

As a special object of cold chain logistics, medicines are directly related to people’s lives and even life safety. It is necessary to strictly ensure the quality of medicines in all links of cold chain logistics, reduce loss, and prevent qualitative changes and pollution.

First, the cold chain transportation of medicines has relatively strict regulations on temperature. Higher or lower than the standard temperature of the medicine itself will have a great impact on the quality of the medicine, which will cause the medicine to deteriorate and lose its efficacy;

Second, in terms of timeliness, since the validity period of drugs is generally short, timely delivery of items to users is the basic requirement of cold chain logistics. Therefore, in the process of drug cold chain transportation, on the premise of providing appropriate temperature Drugs should be delivered in a timely manner with high speed and optimal cost to avoid waste of data and unnecessary economic losses.

Higher logistics costs

Cold chain logistics has always maintained a high threshold price, and the cost of cold chain logistics is 40%-60% higher than that of ordinary logistics. Drug cold chain logistics needs to be loaded, unloaded, stored and transported in a closed environment, and the appropriate temperature is controlled throughout the process. The requirements for logistics transportation are relatively high, so the cost is also high. On the other hand, as a third-party logistics company that mainly provides pharmaceutical cold chain logistics services, in order to realize the whole process of cold chain transportation in the logistics process, it requires not only high technical capabilities, but also strong financial strength. Therefore, in the cold chain logistics Among the cost input of the enterprise, the cost of labor, equipment purchase and transportation is quite high.

High IT requirements

As the demand for pharmaceutical cold chain logistics continues to increase, the information technology of pharmaceutical cold chain logistics, as an important link in the cold chain system, has higher and higher requirements. “Broken chain” often occurs in the cold chain logistics of medicines, so that the quality of medicines cannot be guaranteed. Therefore, the application of advanced logistics information technology in the pharmaceutical cold chain logistics can realize intelligent operation and improve operational efficiency, so that information sharing between the upstream and downstream of the pharmaceutical cold chain logistics system should be realized, and the circulation should be smooth. Logistics personnel should keep abreast of the pharmaceutical drug circulation information, to avoid the phenomenon of “broken chain” of drugs in the process of distribution and transportation, and to ensure the safety of pharmaceutical drugs.

The pharmaceutical cold chain industry is different from other branches of pharmaceutical logistics. The industry itself has the characteristics of safety, sudden demand, high cost, and professionalism. The first is safety. Because different cold chain drugs require different temperatures, if some drugs need to be stored at -5°C or even -20°C, if the refrigeration technology cannot meet the standard, the safety of the drug will not be guaranteed; at the same time, due to The sudden outbreak of many diseases puts forward high requirements on the delivery speed of drugs and the emergency service capabilities of pharmaceutical cold chain enterprises; in addition, the high cost of pharmaceutical cold chain transportation also plays a role in the survival and development of enterprises. restrictive effect.

The professional requirements for cold chain transportation of drugs are extremely high. According to the requirements of the “Quality Management Standards for Drug Operation” revised by the new version of GSP, drug cold chain transportation companies that operate refrigerated and frozen drugs should be equipped with refrigerated trucks and on-board refrigerators or incubators. The cold chain transportation of drugs should use closed cargo transportation vehicles.

1. Professional refrigerated truck

First of all, refrigerated trucks, vehicle-mounted refrigerators, and incubators for cold-chain transportation of drugs should meet the requirements for temperature control during cold-chain transportation of drugs. The refrigerated truck for drug cold chain transportation must have the functions of automatically adjusting temperature, displaying temperature, storing and reading temperature monitoring data; the refrigerated box and incubator for drug cold chain transportation must have the function of external display and collection of temperature data in the box.

Because the relative humidity of drug storage is generally 35% to 75%, it is necessary to monitor and record the temperature data in the refrigerated truck, refrigerator or incubator in real time during the cold chain transportation of drugs. When the goods arrive, key inspections and records should also be carried out on the quality control conditions such as the transportation method, temperature records during transportation, and transportation time, and those that do not meet the temperature requirements should be rejected.

2. Temperature and humidity recorder

In addition, the general conventional medicine temperature requirement is 2℃-8℃, and the low-temperature vaccine requires a freezing requirement of -18°C. But after entering winter, the outside air temperature is lower than 2℃, and the inside of the box must provide heat to heat up. The single-cooling function refrigerator cannot continue to guarantee the temperature standard of 2℃-8℃. It is necessary to add a heating function to the vehicle for continuous supplying hot.

3. Inner frame

According to medicines storage and transportation requirements, medicines should be placed according to batch numbers, and medicines of different batch numbers cannot be mixed. Generally, it is required that the distance between stacks is not less than 5 cm, and the distance between the inner wall, roof, temperature control equipment and pipelines of the warehouse is not less than 30 cm, and the distance between the ground and the ground is not less than 10 cm; The distance between the boards is not less than 5 cm, and the distance from the inner floor of the vehicle is not less than 10 cm.

Therefore, the drug cold chain transport vehicle must be equipped with an inner frame inside the box to increase the distance between the drug and the compartment.

The cold chain transportation of medicines also has strict requirements on the management personnel. Article 28 of the GSP stipulates that personnel engaged in the storage and transportation of specially managed medicines and refrigerated and frozen medicines shall receive relevant laws and regulations and professional knowledge training and pass the examination before taking up their posts. The acceptance personnel of the quality department, the receivers, custodians, reviewers, and delivery personnel of the storage and transportation department conduct cold chain knowledge training at least once a year.

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