挑战

CHALLENGES

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.

解决方案

SOLUTION

DENIOS根据著名的制药企业的要求，提供了极具挑战性的原料药储存解决方案。根据该制药企业的需求，每套系统需要存储8吨的原料药，设备内的温度控制在10～30℃范围内，湿度为≤75%。设备内任意点与点之间的温度差异控制在±3℃。为了满足设备内常年24小时不断的严格温湿度要求，设备内设置了3个额外的温湿度仪，实时将数据传送给智能控制系统，确保空调系统能够精准判断温度及控制出风量。同时，系统配备了两套具备自动切换运行模式（制冷和制热）温湿度运行设备（一用一备）。当一套发生故障时自动切换另一套运行。

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.

为了防止开门及关门时造成冷热空气回流到系统内导致温度发生异常，在每扇防火门顶部都加装了防爆风幕机，并且设置了风幕机的关门延时关闭，确保阻隔柜内外冷暖空气的异常交换。

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.

同时，系统配备三级用户权限。一级能修改所有参数，二级能设定温湿度，三级为只读。因为严格的存储管理需求，系统能够实时检测记录设备内的温湿度状态，并且相关数据可以保存两年。

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.

结果

RESULT

DENIOS的解决方案不仅保障了危险品的安全，更为客户解决了精准存储的需求。并且这整套温度、湿度控制系统的运行不需要人员实时的监控与操作，一切都由智能系统自动运行，这不仅大大降低了风险发生的概率，更减轻了员工的工作负担，降低了企业的运营成本。

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.