Differences, Requirements and Standards between Pharmaceutical Cold Storage and Conventional Cold Storage

2024-09-14

Medical cold storage is mainly used to refrigerate and store various pharmaceutical products that cannot maintain quality under normal temperature conditions. Under low-temperature refrigeration conditions, drugs will not deteriorate or become ineffective, and the shelf life of drugs is extended. The warehouse temperature is generally -5°C to +8°C. The storage and transportation of pharmaceutical products that need cold storage are relatively special and have specific requirements for temperature, humidity, and light exposure. When building a new medical cold storage, it must be strictly accepted in accordance with the requirements of the new version of GSP certification.

I. Differences between medical cold storage and conventional cold storage
(1) On the cold storage panels:
The panels of medical cold storage are rigid polyurethane insulated sandwich panels. Double-sided color steel plates or SUS304 stainless steel plates use advanced eccentric hooks and groove hooks. The eccentric connection method of the panels realizes the tight connection between the panels, and the excellent sealing performance minimizes the leakage of cold air and enhances the insulation effect. This is its advantage. For general cold storage panels, there are choices. It can be polystyrene panels or polyurethane panels, etc. The operating performance of the two will also be different.
(2) On cold storage equipment:
Medical cold storage is planned to have an extra set of refrigeration systems compared to ordinary cold storage. In case the refrigeration unit stops operating due to unexpected situations, the standby unit can continue to work so that the drugs in the warehouse or refrigerated vaccines and related products and equipment that need refrigeration will not be affected. For ordinary cold storage construction, this is not required.

Differences, Requirements and Standards between Pharmaceutical Cold Storage and Conventional Cold Storage1726287807566

In terms of equipment selection, it can also be selected according to customer requirements. Only equipment that can preserve its products is needed. Installation and design can be carried out according to the customer's needs.
(3) In terms of material performance:
The material selection requirements are relatively higher than ordinary ones. Imported parts will be used, and factory inspections will be carried out strictly. Minimize the occurrence of failures as much as possible to avoid damage to drugs, etc. Its refrigeration control system also adopts fully automatic microcomputer electrical control technology, that is, there is no need for manual operation. It automatically regulates the temperature and humidity in the cold storage warehouse to achieve a constant temperature state in the warehouse. It can also be monitored and recorded through a recorder and a fault alarm device to ensure the safe refrigerated storage of drugs.

Differences, Requirements and Standards between Pharmaceutical Cold Storage and Conventional Cold Storage1726287807613

Ordinary requirements are not so strict. Of course, the design and installation specifications of cold storage will also be correctly treated. Manual operation is possible. It depends on the customer's budget range requirements and material selection.

Differences, Requirements and Standards between Pharmaceutical Cold Storage and Conventional Cold Storage1726287807519

(4) On the electric control system:
The electric control box adopts dual power supply control, namely, regular power supply and standby power supply. In addition, an advanced temperature and humidity recorder is configured, which can accurately record and display the temperature and humidity in the cold storage warehouse. It also has a major advantage that a mobile phone automatic alarm can be configured for special customers. This electric control system can flexibly and freely control the switching of the main and auxiliary compressors. It has automatic display, monitoring and automatic alarm functions, and can easily realize the whole process of unmanned automatic monitoring, saving a lot of manpower and financial resources for users, which is economical and convenient.

II. Other requirements of medical cold storage GSP
Article 83 of GSP certification requires enterprises to reasonably store drugs according to the refrigeration characteristics of drugs and strictly abide by the following requirements:

Store drugs according to the temperature requirements indicated on the packaging. If there is no specific temperature indicated on the packaging, the general regulations are: normal temperature warehouse 10°C - 30°C, cool warehouse 0°C - 20°C, medical cold storage 2°C - 8°C;
The relative humidity for storing drugs is 35% - 75%. At the same time, with the continuous improvement of relevant regulations, the construction requirements of medical cold storage are also continuously upgraded. In October 2013, the State Food and Drug Administration issued the storage and transportation management of refrigerated and frozen drugs, the computer system of drug enterprises, automatic temperature and humidity monitoring, drug receipt, inspection and verification management. It put forward detailed requirements on the design, function, volume, operation and use procedures of facilities and equipment of medical cold storage.
In GSP, regulations on computer information management, automatic monitoring of warehouse temperature and humidity, and drug cold chain management are added. Relevant enterprises are required to provide guarantee documents for the safe and effective normal operation of drugs during refrigeration to ensure drug quality. Therefore, the construction and upgrading of medical cold storage is becoming a market need.

III. The installation, commissioning, construction, etc. of medical cold storage equipment strictly comply with standards
For those engaged in the operation of refrigerated and frozen drugs, the following facilities and equipment shall be equipped:
(1) For those engaged in the operation of vaccines, two or more independent cold storages shall be equipped;
(2) Equipment for automatic monitoring, display, recording, regulation and alarm of cold storage temperature;
(3) Standby generator sets or dual-circuit power supply systems for cold storage refrigeration equipment;
(4) For drugs with special low-temperature requirements, facilities and equipment that meet their storage requirements shall be equipped;
(5) Equipment such as refrigerated trucks and on-board refrigerated boxes or insulation boxes.