Measures taken by Chengli refrigerated truck to ensure the safety and quality of medicines
Release time: 2016/7/13 17:43:59
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(A) Chengli refrigerated truck temperature monitoring is of great significance for ensuring the safety of medicines As a special commodity, medicine is directly related to people's life and health issues.Ensuring the quality and safety of drugs in the production, transportation, and storage of drugs is an important issue of common concern to government drug regulatory departments and pharmaceutical enterprises at all levels.Strengthening the supervision of the temperature (humidity) environment of drug storage and distribution is the key to ensuring the safety of drug storage and transportation. This is not only a positive response of drug operation and the implementation of national policies, but also a responsible enterprise to protect the people. An important commitment to medication safety is significant and far-reaching 系统总体要求叙述(B) theoverall system requirements 1. This plan combines the relevant provisions of the new version of the GSP specifications to be promulgated and implemented to provide targeted temperature monitoring solutions for professional drugs during low-temperature transportation. 2. The following functions are realized through this solution: real-time automatic monitoring and recording of the temperature conditions during the storage of low-temperature drugs, effectively preventing various risks that may affect the quality and safety of drugs during storage and transportation, and ensuring the quality of drugs during storage and transportation . 3. According to relevant national regulations, medicines that need to be stored and transported at low temperature (generally at 2-8 ° C), such as freeze-dried powder injections, biological products: blood products, vaccines, etc. must be transported in medical refrigerated trucks during transportation. 4. According to the new national GSP regulations, the entire process of refrigerated medicines from purchase to storage can be effectively controlled, and equipped with a full-temperature monitoring system to ensure that the monitored temperature in the refrigerated vehicle is accurate, real-time, effective and long-term storage. Complete and effective temperature supervision to ensure the quality of refrigerated medicines during transportation, so all medicines responsible for cryopreservation must be monitored throughout the temperature during transportation to ensure the safety of people's medication. 5.Introduction to refrigerated drugs (1) Refrigerated medicines generally refer to short-term, refrigerated stored medicines.Generally refers to the drugs kept at the storage temperature of 2-8 ° C during storage and transportation. (2) Cold-chain medicines generally refer to the entire process from the production to the use of medicines that need to be refrigerated. Cold-chain medicine devices are required to maintain the specified refrigeration conditions (2-8 ° C) during the entire process of storage, transportation and use. (3) What is a vaccine? Generally refers to preventive biological products of vaccines used for human vaccination in order to prevent and control the occurrence and epidemic of infectious diseases. (4) Vaccine cold chain generally refers to storage, transportation and refrigerated facilities and equipment equipped to ensure the quality of the vaccine during the operation of the vaccine from the vaccine manufacturing enterprise to the vaccination unit. (5) Scope of refrigerated drugs Generally, all drugs that require storage under low temperature conditions (generally 2-8 ℃), such as lyophilized powder injections, biological products: blood products, vaccines, etc. belong to the category of refrigerated drugs. The vast majority of biological products or drugs produced using biological agent technology are refrigerated drugs stored at 2-8 ° C.The main products of biopharmaceuticals include recombinant protein drugs, recombinant vaccines, and monoclonal antibodies for diagnosis and treatment.Data show that the drugs and vaccines that have been approved for production now include: human interferon alb (oral); ② genetically engineered human interferon alb (matching gold); ③ recombinant human interferon a2a (interferen); ④ recombinant human Interferon a2b; ⑤ recombinant human interferon γ; ⑥ recombinant human interleukin-2; ⑦ recombinant human erythropoietin; ⑧ recombinant human granulocyte colony-stimulating factor; 人 genetically engineered streptokinase; ⑩ basic fibroblast growth factor; ⑾ Recombinant Human Granulocyte Macrophage Colony Stimulating Factor. At the current stage, there are hundreds of varieties of refrigerated drugs in some large pharmaceutical companies.The management of refrigerated medicines has emerged and needs urgent solution.The new version of the GSP also sets out clear requirements for cold-chain temperature monitoring. Refrigerated medicines must be transported by cold-chain vehicles, and the temperature in the compartment must be 2-8 ° C. The temperature must be monitored and recorded throughout the process to be well-documented. It can be checked, it must be accurate and effective to monitor the temperature of the refrigerated truck, and ensure the quality and safety of the medicine device transportation process. 6.Introduction to refrigerated trucks Refrigerated truck is a closed van used to transport frozen or fresh-keeping goods. It is a refrigerated transport vehicle equipped with a refrigeration unit and a polyurethane heat insulation box. It is often used to transport frozen food (frozen trucks) and dairy products. (Dairy transporter), vegetables and fruits (fresh transporter), vaccines (vaccine transporter), etc. Refrigerated truck composition: The refrigerated truck is composed of the walking part of the dedicated car chassis, and the thermal insulation box (generally composed of polyurethane material, glass fiber reinforced plastic, color steel plate, stainless steel, etc.), the refrigeration unit, and the car is equipped with a cold chain temperature vehicle screen Temperature recording and wireless communication function) and other components, for vehicles with special requirements, such as meat hook car, can be installed meat hook, waist, aluminum alloy rails, ventilation slots and other optional components. Refrigerated truck unit classification: Refrigeration units are divided into non-independent refrigeration units and independent refrigeration units.Domestic units and imported units.General models use external coolers, and a few mini-refrigerators use built-in coolers.For refrigerated vehicles with lower temperature requirements, a built-in cold plate (function equivalent to an evaporator) can be adopted.
All medicines that need to be refrigerated must be transported in refrigerated trucks. The design requirements of refrigerated trucks are as follows: The box body uses inner and outer glass fiber reinforced plastic, polyurethane insulation material, aluminum alloy edging for the box body, and the back door frame uses stainless steel locks. The interior of the cabin must be equipped with UV disinfection lighting equipment. The body of the whole car is made of bio-safety-grade material, which keeps the temperature inside the car balanced and effectively inhibits the growth of bacteria.The box body adopts the “sandwich” type board bonding process: the inner and outer wall panels are made of high-quality mechanism glass steel plate, which is beautiful and strong; the middle insulation material is selected from the new 80mm thick polyurethane foam material, which has excellent heat insulation performance; Hemming, high overall strength and high performance. The car body has the characteristics of light weight, high strength, no seams, beautiful appearance, good thermal insulation, and corrosion resistance.Using standard stainless steel, galvanized door lock, beautiful and elegant, solid and durable. Using well-known domestic and foreign brand refrigeration units to achieve automatic temperature adjustment to achieve the perfect combination of power and refrigeration. Equipped with temperature recorder and GPS, it can realize the function of recording temperature values in different time periods and different locations. Can carry out structural design according to customer requirements, install refrigeration unit according to customer requirements.