The pharmaceutical cold storage is mainly refrigerated and stored in the normal temperature conditions can not guarantee the quality of all kinds of pharmaceutical products, in the low temperature refrigeration conditions to make the drug does not deteriorate, extend the shelf life of drugs, the storage temperature is generally -5℃ ~ +8℃. The storage and transportation of pharmaceutical products requiring cold storage is relatively special, and has specific requirements for temperature, humidity, visibility, etc. When the new medical cold storage must be strictly in accordance with the requirements of the new GSP certification to acceptance.
First, the difference between medical cold storage and conventional cold storage
(1) On the cold storage board: the library board of the medical cold storage is a rigid polyurethane thermal insulation sandwich board, double-sided color steel plate or SUS304 stainless steel plate, the use of advanced bias hook and slot hook, the connection method of the library board bias to complete the close connection between the library board and the library board, excellent sealing to minimize the leakage of cold air and enhance the heat insulation effect. This is its advantage, and the general cold storage board is selective, can be polystyrene library board, but also polyurethane library board. The performance of the two will also be different.
2) Cold storage equipment: medical cold storage from the planning scheme than the general cold storage to prepare a set of refrigeration system. In case of emergency, if the refrigeration unit stops operation due to unexpected conditions, it can continue to work through the standby unit, which will not affect the drugs in the library. Or refrigerated vaccines and related products requiring refrigeration equipment. The construction of ordinary cold storage is not necessary, and the choice of equipment can also be selected according to the requirements of customers, only need to meet the products that can keep it fresh. See what the customer's needs are to reference the installation design.
(3) Raw material performance: material selection is relatively higher than ordinary, imported parts will be used, strict inspection of the factory and so on. As far as possible to reduce the occurrence of failure, so as to avoid damage to the drug. Its refrigeration control system is also the use of automatic microcomputer electrical control technology, that is, without manual operation, automatic control of the cold storage temperature and humidity, which reaches the constant temperature in the library. It can also monitor and record through the recorder and fault alarm device; To ensure safe storage of medicines. The ordinary requirements are not so strict, of course, they will also treat the design and installation specifications of the cold storage correctly, which can be manually operated, depending on the customer's budget range requirements and the choice of materials.
4) On the electronic control system:
The electric control box adopts dual power control, that is, conventional power supply and standby power supply, and is equipped with advanced temperature and humidity recorder, which can accurately record and display the temperature and humidity in the cold storage warehouse. There is also a biggest advantage, which can configure mobile phone automatic alarm for special customers. The electronic control system can flexibly and freely control the switch of the main and auxiliary compressors, with automatic display, monitoring and automatic alarm functions, and can easily realize the whole process of unmanned automatic monitoring, which can save a lot of manpower and financial resources for users, economic and convenient.
Second, medical cold storage GSP other requirements
Article 83 requires that enterprises shall rationally store drugs according to the refrigeration characteristics of drugs, and strictly comply with the following requirements:
1. Store drugs according to the temperature requirements indicated on the package, and if the specific temperature is not marked on the package, store them according to the storage requirements stipulated in the Pharmacopoeia of the People's Republic of China (National Pharmacopoeia stipulates: 10℃~30℃ for normal temperature storage, 0℃~20℃ for cool storage, 2℃~8℃ for pharmaceutical cold storage).
2. The relative humidity of stored drugs is 35%~75%. At the same time, with the continuous improvement of relevant regulations, the construction requirements of pharmaceutical cold storage are also constantly upgraded. In October 2013, the Food and Drug Administration issued five appendices, including storage and transportation management of refrigerated and frozen drugs, computer system of drug distribution enterprises, automatic temperature and humidity monitoring, drug receipt and acceptance and verification management, as supporting documents of the "Good Practice for the Quality Management of Drug Distribution". The design, function, volume, operation of facilities and equipment, operation procedures of medical cold storage are put forward in detail.
3. GSP adds provisions on computer information management, automatic storage temperature and humidity monitoring, drug cold chain management and other requirements, and requires relevant enterprises to provide documents guaranteeing the safe and effective normal operation of drugs in the cold storage process to ensure the quality of drugs. Therefore, the construction and upgrading of pharmaceutical cold storage is becoming a market need.
Third, the installation, commissioning and construction of medical cold storage equipment strictly abide by national standards
Technical Specification for Verification Performance of temperature control Facilities for Pharmaceutical Products Cold Chain Logistics Equipment (GB/T 34399-2017), Construction and Acceptance Code for Installation of refrigeration equipment and air separation Equipment (GB50274-2010), Construction Quality Acceptance Code for water supply and drainage and heating Engineering (GB50242-2002) Specification for Quality Acceptance of Ventilation and air conditioning Engineering (GB50243-2016) Standard for Indoor prefabricated cold storage (SB/T10797-2012) and related maps and standards as shown in construction drawings.
In addition, on November 6, 2012, the State issued the "Good Practice for the Quality management of Drug Management", "Good practice for the management of vaccine storage and Transportation" and "Good practice for the quality management of plasma Collection stations" on the standard of cold storage in the pharmaceutical industry.
The details are as follows: "Drug trade quality management standards" Article 49 of the operation of refrigerated and frozen drugs, shall be equipped with the following facilities and equipment:
(1) Those dealing in vaccines shall be equipped with two or more independent cold stores;
(2) Equipment for automatic temperature monitoring, display and record, regulation and alarm in cold storage;
(3) the standby generator set of the cold storage refrigeration equipment or the double circuit power supply system;
(4) For drugs with special low temperature requirements, facilities and equipment that meet their storage requirements shall be equipped;
(5) refrigerated vehicles and vehicle refrigerated boxes or incubators and other equipment.
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