Differences, requirements and standards between pharmaceutical cold storage and conventional cold storage

The pharmaceutical cold storage mainly refrigerates and stores various pharmaceutical products that cannot be guaranteed under normal temperature conditions. Under the condition of low temperature refrigeration, the medicines will not deteriorate and become invalid, and the shelf life of the medicines will be extended. The storage temperature is generally -5 °C ~ +8 °C. The storage and transportation of pharmaceutical products that require cold storage are special, and have specific requirements for temperature, humidity, and visibility. When building a new pharmaceutical cold storage, it must be checked and accepted in strict accordance with the requirements of the new version of GSP certification.

First, the difference between medical cold storage and conventional cold storage

(1) Cold storage board:
The storage board of the medical cold storage is made of rigid polyurethane heat-insulating sandwich panel, and the double-sided color steel plate or SUS304 stainless steel plate is selected with advanced eccentric hooks and groove hooks. The tight connection between them, the excellent sealing performance minimizes the leakage of cold air and enhances the thermal insulation effect. This is its advantage, and the storage board of general cold storage is selective, which can be polystyrene storage board or polyurethane storage board. The performance of the two will also be different.

(2) On the cold storage equipment:
Compared with the general cold storage, the medical cold storage needs to prepare one more refrigeration system from the planning scheme. Just in case, if the refrigeration unit stops running due to an emergency, the standby unit can continue to work, which will not affect the medicines in the warehouse. Or refrigerated vaccines and related product equipment that requires refrigeration. The construction of ordinary cold storage is not required, and the selection of equipment can also be selected according to the requirements of customers. It only needs to meet the products that can keep it fresh. See what the customer's needs are to carry out the reference installation design.

(3) In terms of raw material properties:
The material selection is relatively higher than ordinary ones. Imported parts will be used, and the factory will be strictly inspected. Minimize the occurrence of failures to avoid damage to medicines, etc. Its refrigeration control system also adopts automatic microcomputer electrical control technology, that is, without manual operation, the temperature and humidity in the cold storage can be automatically adjusted and controlled to achieve a constant temperature in the storage. It can also be monitored and recorded by a recorder and a fault alarm device; to ensure the safe refrigerated storage of medicines. The general requirements are not so strict, of course, the design and installation specifications of the cold storage will be correctly treated, which can be operated manually, depending on the customer's budget range requirements and material selection.

(4) On the electronic control system:

The electric control box adopts dual power supply control, namely conventional power supply and backup power supply, and is equipped with an advanced temperature and humidity recorder, which can accurately record and display the temperature and humidity in the cold storage. . This electronic control system can flexibly and freely control the switching of the main and auxiliary compressors. It has automatic display, monitoring and automatic alarm functions. It can easily realize unmanned automatic monitoring throughout the process, which can save users a lot of manpower and financial resources, and is economical and convenient.


2. Other requirements of GSP for pharmaceutical cold storage

Article 83 of GSP certification requires that enterprises should store medicines reasonably according to their refrigeration characteristics, and strictly abide by the following requirements:

1. Store medicines according to the temperature requirements marked on the package. If the specific temperature is not marked on the package, store them in accordance with the storage requirements stipulated in the "Pharmacopoeia of the People's Republic of China" (the Chinese Pharmacopoeia stipulates: 10 ℃ ~ 30 ℃ in normal temperature warehouse, 0 ℃ ~ 0 ℃ in cool warehouse) 20℃, medicine cold storage 2℃~8℃);

2. The relative humidity of stored medicines 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 China Food and Drug Administration issued five appendices, including the management of storage and transportation of refrigerated and frozen drugs, the computer system of drug business enterprises, the automatic monitoring of temperature and humidity, and the management of drug receipt and acceptance and verification, as the "Quality of Drug Business". Management Specification" supporting documents. Among them, detailed requirements are put forward for the design, function, volume, operation and use procedures of facilities and equipment of medical cold storage.

3. The requirements for computerized information management, automatic monitoring of storage temperature and humidity, and drug cold chain management are added to GSP, and relevant enterprises are required to provide guarantee documents for the safe and effective normal operation of drugs during the refrigeration process to ensure drug quality. Therefore, the construction and upgrading of pharmaceutical cold storage is becoming a market demand.

3. The installation, commissioning and construction of medical cold storage equipment strictly abide by national standards

"Technical Specification for Verification Performance Confirmation of Temperature Control Facilities and Equipment for Cold Chain Logistics of Pharmaceutical Products" (GB/T 34399-2017) "Code for Construction and Acceptance of Refrigeration Equipment and Air Separation Equipment Installation Engineering" (GB50274-2010) "Building Water Supply and Drainage and Heating Engineering" Construction Quality Acceptance Specification" (GB50242-2002) "Ventilation and Air Conditioning Engineering Construction I Quality Acceptance Specification" (GB50243-2016) "Indoor Prefabricated Cold Storage" Standard (SB/T10797-2012) and the relevant atlas shown in the construction drawings, standard.

In addition, on November 6, 2012, the State issued the "Quality Management Specification for Pharmaceutical Business", "Vaccine Storage and Transportation Management Specification" and "Quality Management Standard for Plasma Collection Stations", which stipulated the specifications for the cold storage standards in the pharmaceutical industry.

The details are as follows: Article 49 of the "Good Management Practice for Drug Distribution" that deals in refrigerated and frozen drugs shall be equipped with the following facilities and equipment:
(1) Vaccine operators shall be equipped with two or more independent cold storages; 
(2) Equipment for automatic temperature monitoring, display record, regulation and alarm in the cold storage;
(3) Standby generator sets or dual-circuit power supply systems for cold storage refrigeration equipment;
(4) For medicines with special low temperature requirements, facilities and equipment that meet their storage requirements shall be provided; 
(5) Equipment such as refrigerated trucks and vehicle-mounted refrigerators or incubators.

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