What are the differences between a pharmaceutical cold room and an ordinary cold room? Cold storage is widely used in various industries, especially in the food and pharmaceutical industries. In these fields, there are many significant differences between pharmaceutical cold storage and ordinary cold storage, mainly in the design requirements, functions, management standards and other aspects. This article will analyse in detail the six major differences between the pharmaceutical cold storage and ordinary cold storage.
the temperature control requirements
1. Temperature range
Pharmaceutical cold storage usually requires stricter temperature control to meet the storage requirements of drugs. According to different drugs, the cold storage may need to be set at 2-8 ℃ (refrigerated) or -20 ℃ below (frozen) and other detailed temperature range. While the temperature range of ordinary cold storage is relatively broader, it can usually be set in a larger range such as 0-4℃ or -18℃ according to the type of food.
2. Temperature fluctuation
Pharmaceutical cold storage requirements for temperature fluctuations are more stringent, usually requires a temperature difference of ± 1 ℃. The general cold storage can accept relatively large temperature fluctuations, usually within ± 5 ℃.
storage contents
1. Types of storage items
Pharmaceutical cold storage is mainly used to store drugs, vaccines, biological products and other sensitive goods that require specific temperature conditions. On the other hand, ordinary cold storage is mainly used for storing food, fruits and vegetables, beverages and other storage-resistant goods.
2. Shelf life of goods
The expiry date and shelf life of drugs are more sensitive, so the storage conditions must be strictly controlled. The shelf life of common food is relatively long and can be extended by means of freezing, so the requirements for storage conditions are not so strict.
Facilities and equipment
1. Refrigeration equipment
Pharmaceutical cold storage is usually equipped with high-precision refrigeration equipment, these devices need to ensure that in the event of a failure to respond in a timely manner, and has multiple redundancy systems. The ordinary cold storage refrigeration equipment is relatively simple, usually without such high technical requirements.
2. Temperature and humidity monitoring
Pharmaceutical cold rooms are equipped with an advanced temperature and humidity monitoring system that monitors the environmental conditions in real time and triggers an alarm in the event of temperature and humidity abnormalities. On the other hand, ordinary cold storage may not need such a detailed monitoring system, and a simple thermometer or hygrometer can meet the requirements.
Management and operation standard
1. Operation standard
Pharmaceutical cold storage has more strict operation manuals and standard operating procedures to ensure that every operation in and out of the warehouse meets the regulatory requirements for drug storage. The management of general cold storage is relatively flexible, and the standard is not as strict as that of pharmaceutical cold storage.
2. Personnel training
The operation and management personnel of pharmaceutical cold storage usually need special training, with knowledge of cold chain management and drug characteristics. On the other hand, the operation training of general cold storage is relatively simple, focusing on basic storage and cold chain management skills.
Laws, regulations and standards
1. Regulatory requirements
The design and operation of pharmaceutical cold storage need to follow the strict requirements of the State Drug Administration and relevant laws and regulations, such as the Drug Administration Law and the Drug Storage Standard. The laws and regulations to be followed by common cold storage are relatively loose, mainly involving food safety requirements.
2. Certification requirements
Pharmaceutical cold rooms usually need to be certified by the Drug Administration to ensure that they meet the standards for pharmaceutical storage. Ordinary cold storage does not need specific certification, and enterprises can set standards according to their own needs.
Emergency Response and Monitoring
1. Emergency plan
Pharmaceutical cold storage usually has a detailed emergency plan for equipment failure, temperature exceeds the standard, power outages and other emergencies have a complete response process to ensure the safety of medicines. On the other hand, the emergency treatment of common cold storage is relatively simple, and only basic emergency power supply or backup equipment is usually required.
2.Data recording
Pharmaceutical cold rooms need to maintain real-time records of temperature and humidity for auditing and quality traceability. Regular cold rooms may not involve such detailed data logging, relying mainly on general storage records.
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