Application of one-way flow design in biological clean room

Application of one-way flow design in biological clean room

The application of one-way flow design in biological clean room is as follows:

A. Local airflow pattern

Generally, there will be several unidirectional flow protection zones in the core area at the same time, and the influence of local airflow movement on the room environmental conditions must be considered during the operation; when the operation is carried out, the air pattern will be changed...

Text label: One-way flow clean room, biological clean room design

One-way flow design application in biological clean room

The application of one-way flow design in biological clean room is as follows:

A. Local airflow pattern

Generally, there will be several unidirectional flow protection zones in the core area at the same time. The influence of the local airflow movement on the environmental conditions of the room during the operation must be considered; when the operation is carried out, the air pattern will be changed, and the space The heat load is also very large. For example, the heat generated by the equipment is heated, and the heat generated by the cooling of the items after sterilization will generate the flow of hot air, but this indirect air flow cannot take away pollutants or particles from personnel, etc. Risks to the core area environment remain.

One-way flow shields can blow air from a cleaner environment (including exposed areas such as product, container/packaging, or product contact surfaces) towards the operator or other potential sources of contamination. The airflow pattern of the clean room modular must be Under simulated operating conditions, this was confirmed by the smoke test method.

B. Pair comparison of horizontal and vertical unidirectional flow

One-way flow protection device has two forms: vertical flow and horizontal flow, each with its own advantages and disadvantages. Figure 3.4-9 is a comparison of horizontal one-way flow and vertical one-way flow protection.

Which form of unidirectional flow protection device is selected is determined by the items or operating steps to be protected, especially involving operator intervention and other potential sources of contamination, ideal typical operating activities should be as close to unidirectional flow as possible Protect the surface while keeping the operator in the downwind direction, as shown in Figure 3.4-10

Figure 3-9 Ratio of horizontal unidirectional flow to vertical unidirectional flow

When a large thermal load is cooled, such as a cart loaded with vials from a hot air oven, the hot air will interfere with the forced vertical airflow; therefore, the design must ensure that the vertical airflow can fully protect the items on the lower level of the cart. In this case,

Protective curtains are available.

Figure 3-10 Comparison of thermal flow and vertical unidirectional flow

When there are obstacles in the unidirectional flow, it is possible to form a dead zone in the downstream area, resulting in a potential 'shadow' problem, as shown in Figure 3-11. In this case, even higher air changes will not reduce the particle count enough, and it is possible that a higher particle count will be recorded in the core protection zone. area.

Figure 3-11 Shadows of one-way flow

FDA aseptic implementation guidelines give the end air flow rate of one-way flow hood 0.45m/s ± 20%, this value comes from the FS209E standard, and the flow rate required to meet the protection of the core area must be determined during system validation , record, and serve as the basis for process monitoring. The design of the local protection system must address potential conflicts, including the protection of product quality, employee protection, and operability. From the perspective of GMP, the protection of product quality is a very important protection, but a balance point must be found to protect the product from the influence of personnel, and vice versa, a physical isolation device can be used to solve this contradiction. Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of clean rooms and purification projects.

There are numerous technical sources mentioning the use of barriers or drapes for the protection of unidirectional flow areas, the design of which is not discussed in this article, but it is pointed out that in many cases such a system is necessary. Advanced computer-aided airflow design procedures have been used, which can help build initial room airflow patterns and unidirectional flow models, but fine-tuning is required at a later validation stage.

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