Medical Device Purification Engineering - Design Specification for Aseptic Cleanroom Engineering Reference:
1. International standard ISO/DIS 14644
2. Design Code for Cleanroom and Factory Buildings GB50073-2001
3. Medical Device Packaging Workshop Cleanroom Building Specification GMP-97
4. Good Manufacturing Practice for Drugs (GMP-98)
5. Clean room construction and difficult to receive specifications JGJ 71-90
6. Code for Construction and Acceptance of Ventilation and Air Conditioning Engineering (GB 50243-2002)
7. US Federal Standard FS209E-92

According to relevant regulations, clean rooms that meet relevant standards are required to be built in sterile medical device production workshops, drug production workshops, medical biology laboratories, operating rooms, etc. When constructing or renovating a clean room, it is not necessary to rely on the final completion acceptance to ensure the quality of the clean room. Strict control must be carried out from the design and equipment selection stage, and the main key points must be strictly inspected and supervised throughout the construction process. Regular monitoring during actual use is necessary to ensure that the clean room meets the design specifications and usage requirements.

Aseptic medical devices are any medical devices labeled as "sterile". The production clean room is the basic condition for ensuring the quality of sterile medical devices. The environment for controlling the production process of sterile medical devices and regulating their production to prevent environmental pollution of sterile medical devices. The clean room must meet the requirements of the specified environmental parameters for construction and regular monitoring.

In the construction of medical device purification engineering, the following issues need to be considered:
1. Purification materials required for clean room engineering in medical device packaging workshop;
2. Comprehensive services including design, installation, commissioning, and maintenance of clean rooms in medical device factories and packaging workshops;
3. Medical device packaging workshop clean room engineering air conditioning purification part

Temperature and relative humidity
When there are no special regulations, sterile medical devices usually require a temperature of 18-28 ° C according to regulatory standards and testing, and a humidity of 45%~65%. Enterprises can generally control it within the requirements. If it is found during dynamic monitoring that the requirements are not met, it may be due to the presence of high heat generating instruments and equipment indoors.

Airflow, air exchange rate, static pressure difference
When the volume of the clean room is determined, the number of air changes is determined by the supply air volume of the room, while the static pressure difference depends on the difference between the supply air 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 achieved by adjusting the frequency and speed of the fan or the opening degree of the main valve. The air volume and pressure of each room can be achieved by adjusting the opening degree of the branch pipeline valves.

During the actual testing process, it was found that when adjusting the air supply volume of a clean room with an unqualified ventilation rate by adjusting the branch air valve, it often causes changes in the air supply volume of other clean rooms in the same clean area, which disrupts the air distribution of the entire clean area and makes the problem more complex. In addition, it is common to encounter situations where the ventilation rate is qualified but the pressure difference is unqualified, which is more common in the second scenario. The main reason is the poor airtightness of the protective structure and the difficulty in adjusting the return air grille.