在制药领域，原料药的储存要求极高。首先，一些原料药的自身化学性质属于危险性较高的甲类易燃化学品，需要满足对于甲类化学品的存储要求，比如240分钟的防火性能，整体的防爆级别；所有电器设备必须满足GB 5226.1-2019 《机械安全 机械电气设备第一部分：通用技术条件》，其次，一些原料药不仅对于储存环境的温度、湿度有着严格的要求，还对操作存储的智能化有较高要求。
In the pharmaceutical sector, the requirements for storing active ingredients are extremely high. Some APIs must meet storage requirements for Class A flammable chemicals, such as 240 minutes of fire resistance. In addition, the general explosion protection level must be maintained by all electrical equipment complying with GB 5226.1-2019 “Electrical safety of machines - Electrical equipment of machines - Part 1: General requirements”. Furthermore, some APIs have strict requirements for the temperature and humidity of the storage environment. To ensure that these protective measures are effective at all times, the control logic and system monitoring must be adapted accordingly.
DENIOS offers technical room modules for the storage of active ingredients that meet the requirements of well-known pharmaceutical companies. For a current order, several technical room systems were delivered, each capable of storing 8 tonnes of APIs. The temperature inside the room system is controlled in the range of 10-30°C and the humidity is ≤75%. The temperature difference between each point within the system is controlled to ±3. In order to meet the strict temperature and humidity requirements, there are three temperature and humidity meter inside the room system to transmit data in real time so that the air-conditioning system can accurately detect the temperature and control the amount of air. Redundant equipment with temperature and humidity operating devices ensures automatic switching between the cooling and heating operating modes and operational backup in the event of a failure.
In order to ensure that the temperature in the room system is not affected when the door is opened and closed, DENIOS installed an explosion-proof air curtain machine at the top of each fire door and set up the shutdown delay of the air curtain machine.
The system has three levels of user rights. Level 1 can change all parameters, Level 2 can adjust temperature and humidity, and Level 3 is read-only. Due to the strict control and documentation requirements, the room system has the function of real-time monitoring and recording of the temperature and humidity status. The relevant data is stored for two years.
The solution provides safe and precise air conditioning when storing temperature and humidity sensitive materials. In addition, temperature and humidity control is handled by the system and requires no manual activity on the part of the operator. Everything runs automatically via the intelligent system, which not only significantly reduces the likelihood of risks occurring, but also reduces the workload of employees and reduces the company's operating costs.