| Medical cleaning engineering
In the relevant specification requirements of medical cleaning engineering, the construction of medical device cleaning workshop, medical biological laboratory, drug production workshop or operating r
Apr 11, 2022
The specifications for the engineering design of medical cleaning engineering sterile clean room refer to:
1. International standard ISO / DIS 14644
2. Code for design of clean room workshop GB50073-2001
3. Specification for clean room workshop of medical device packaging workshop gmp-97
4. Gmp-98, good manufacturing practice
5. Code for construction and difficult collection of clean room JGJ 71-90
6. Code for construction and acceptance of ventilation and air conditioning engineering (GB 50243-2002)
7. Federal standard fs209e-92
In the relevant specification requirements of medical cleaning engineering, the construction of medical device cleaning workshop, medical biological laboratory, drug production workshop or operating room must meet the relevant standards of clean room construction in China. Generally speaking, when building or transforming the clean room project, in order to better meet the standards of clean room construction, enterprises must strictly control the quality in the design stage and equipment selection stage of pharmaceutical clean Engineering, strictly inspect and supervise the main key points in the construction of pharmaceutical clean workshop, and regularly monitor the clean room in later use, In order to ensure that the construction of pharmaceutical clean workshop can meet the design indicators and use requirements, rather than relying on completion acceptance to ensure the quality of clean room.
The requirement of "sterility" is often emphasized in the production of medical devices. The so-called sterile medical devices are those medical devices marked with the word "sterility". The aseptic production conditions of the medical cleaning workshop are the key factors to ensure the quality of aseptic medical devices. A qualified medical cleaning project can not only provide a good environment for the production of sterile medical devices and standardize the production requirements of enterprises, but also avoid the pollution caused by environmental pollution to the production of sterile medical devices. Therefore, in the construction of the clean room project, it must meet the requirements of the specified environmental parameters for construction and regular monitoring.
The following three issues should be considered in the construction of medical device clean room project:
1. Purification materials required for the clean room project of medical device packaging workshop;
2. Comprehensive services such as design, installation, commissioning and maintenance of clean room engineering in medical device workshop and medical device packaging workshop;
3. Air conditioning purification part of clean room project of medical device packaging workshop
In the construction of medical cleaning engineering, in order to better meet the requirements of construction standards, it is necessary to strictly control the temperature, humidity and differential pressure. Firstly, the construction requirements of temperature and relative humidity of clean room project: under the premise of no special regulations, the temperature of sterile medical device cleaning workshop needs to be controlled at 18-28 ℃, and the humidity needs to be controlled at 45% - 65%. In general medical cleaning projects, both of them are not difficult to achieve. Temperature and relative humidity mainly affect the product production process and bacterial reproduction conditions, and can also lead to the impact of the comfort of production operators on the product quality. If the temperature or humidity fails to meet the requirements in dynamic monitoring, it may be caused by instruments and equipment with large heat production in the room.
Requirements for air volume, ventilation times and static pressure difference in the construction of medical cleaning engineering: when the volume of the clean workshop is determined, the ventilation times are determined by the air supply volume of the room, and the static pressure difference depends on the difference between the air supply volume, return air volume and exhaust air volume of the room. The total supply air volume, fresh air volume, total exhaust air volume and external pressure difference of the system can be realized by adjusting the fan frequency and speed or the opening of the total valve, and the air volume and pressure of each room can be realized by adjusting the opening of the valve of the branch pipeline.
In the actual detection process, it is found that when adjusting the air supply volume of a clean room with unqualified ventilation times by adjusting the branch pipe air valve, the air supply volume of other clean rooms in the same clean area will often change, that is, the air distribution of the whole clean area will be disrupted, which makes the problem more complex. In addition, it is often encountered that the ventilation times are qualified and the differential pressure is unqualified, which is more common in the second stage. The main reasons are poor air tightness of the enclosure structure and difficult adjustment of the return air inlet grid.
In the dynamic monitoring of clean rooms, personnel flow, insufficient fresh air volume and frequent door opening are the main reasons for the change of pressure difference between clean rooms. If the static pressure difference between clean rooms and atmosphere or between clean rooms of different levels is in a critical state, the dynamic detection is likely to cause the pressure difference to fail to meet the requirements due to insufficient personnel flow and fresh air volume supplement.
Requirements for suspended particles, planktonic bacteria and settling bacteria in the construction of medical cleaning project: if the test conditions cannot meet the requirements of specified environmental parameters (temperature and humidity, wind speed, ventilation times and static pressure difference are within the specified range), the test results of suspended particles, planktonic bacteria or settling bacteria in key projects shall be deemed invalid. As temperature, relative humidity, wind speed, ventilation times and static pressure difference jointly constitute the microclimate of the clean room and are important indicators of whether the clean room is maintained normally or not, the key item test of key processes can be revised to the full performance test of key processes. Only when the relative humidity and humidity of the production room are monitored scientifically, can the accuracy of the relative humidity and suspension system be ensured.
The test standards for the temperature, relative humidity, wind speed, ventilation times and static pressure difference in the design of pharmaceutical clean workshop and clean room of sterile medical devices are implemented in accordance with the code for design of clean workshop. The problems in the design of clean room project of pharmaceutical factory also have reference value for the clean room of sterile medical devices.