Seven Keypoints in Pharma Clean Room Design
|10.5.2021||Posted by pharmasources under Advertising & Marketing|
- The design and construction of the pharma clean room exceed standards
(1) For companies that consist of multiple clean rooms with requirements from 10,000 to 300,000, the design and contractor will uniformly follow the requirements of 10,000, so that the design and construction are much easier, and the system debugging becomes relatively easy.
(2) Improve the cleanliness level of the pharma clean room. For example, according to the requirements of the “Pharmaceutical Production Quality Management Regulations” (revised in 1998), the production workshop of oral solid preparations can reach 300,000, but the production enterprise designs according to 100,000; the area of the clean room is too large, and the height of the room is too high. Companies can reserve some rooms for future development, but they do not need to open the air purification system.
(3) Except for pharma clean rooms that have special requirements for the process, such as extraction rooms, drying rooms, etc., the height of the pharmaceutical clean room is generally 2.6 meters to 3.0 meters, but some companies do not know why the entire workshop is unified to be 4.0 Meters high. The height should according to the different requirements of different production processes and different production processes for environmental cleanliness. The area of the high cleanliness level should be minimized, and the local high-level purification and the lower-level purification of the whole room should be used. The clean room system replaces the clean room system with high-level purification of the whole room. It can not only ensure the requirements of different production processes on the production environment, but also greatly reduce the initial investment and operating costs.
- The number of air changes in the pharma clean room is unreasonable
The number of air changes, the pressure difference, and the number of suspended particles are the three most basic requirements of a clean room. Whether it is the dilution effect of the turbulent flow or the displacement effect of the single-phase flow, the amount of clean air is required to control and to realize various parameters of the clean room, so the number of air changes in the clean room cannot be too low.
- It is not advisable to use the method of sending and returning
Due to historical reasons, individual clean rooms still use the air-sending method of top-to-back and top-to-back. The biggest advantage of sending back to back is low cost and saving money, but it will at least appear in the following situations:
(1) At a certain height (such as the breathing zone), there are many large particles of 5μm, which are often measured by 0.5μm, but not by 5μm.
(2) If it is a local 100-level occasion, the wind speed in the work area is often very small, and it is difficult to reach the standard.
(3) The self-cleaning time is longer, and the actual test shows that the self-cleaning time can be doubled. Although the upload and return method may reach the design cleanliness level in some empty state determinations, it is not conducive to the removal of pollution in the dynamic state, and is not recommended.
- There are problems with some hundred grades
Some companies have no major production quality problems before installing the partial 100 grade, but after installing the partial 100 grade, certain indicators of the product, such as clarity, decrease, and the reject rate greatly increases. There are several reasons for this kind of phenomenon:
(1) The quality of the high-efficiency filter is unqualified, and it has not been inspected one by one when leaving the factory, and there are loopholes.
(2) The installation quality of the high-efficiency filter is unqualified. That is, the high-efficiency filter is not pressed down or up by the screw on the rubber gasket on the frame, but screwed on the self-tapping screw on the tuyere wall, which can only be blown looser.
(3) The air velocity of single-phase flow is small, and it cannot be discharged immediately after pollution occurs.
(4) The design of the local unidirectional flow and the background non-unidirectional flow air outlet is unreasonable. The non-unidirectional flow air outlet is close to the centralized air outlet, which will definitely interfere with the unidirectional flow under the centralized air outlet. The flow air outlet is arranged on one side of the centralized air outlet, and the other side has only a single-sided return air outlet, which will cause greater interference to the bureau, especially the downwind side will be more affected.
(5) The production staff did not fully implement the clean work system, and the pollutants carried by themselves (such as pollution in the clean clothes, not wearing sterile caps, masks, etc.) were accelerated to the production line.
- The layout of various facilities in the pharma clean room
Inadequate consideration of the impact on air flow pattern and air cleanliness
(1) The non-unidirectional flow clean room is only equipped with one-sided return air, which increases the vortex area of the non-unidirectional flow clean room and also increases the chance of cross contamination. For example, the operator, the working area is located between the supply air outlet and the return air outlet.
(2) The return air outlet of the non-unidirectional flow clean room is not far away from the working area.
(3) The process equipment to be exhausted is not arranged on the leeward side of the clean room; the residual pressure valve is not arranged on the leeward side of the clean air flow.
- The number of air outlets in the pharma clean room is too small
The design of the clean room is due to the limitation of the site conditions or the excessive pressure of the investment. The number of air outlets is often reduced inappropriately. As a result, the air outlet speed is equal to the number of air changes.
- Selection of filter
The selection of unreasonable filters should comply with the following points: the performance of the final filter should be reliable, the efficiency specifications of the pre-filter should be reasonable, and the maintenance of the primary filter and pre-filter should be convenient. In addition, high-efficiency filters must be inspected one by one. If possible, choose a filter with a large filter area as much as possible.
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