Clean workshops and clean laboratories are the basic conditions for ensuring the product quality of pharmaceuticals, medical equipment and packaging materials that directly contact drugs, and the quality of pharmaceutical preparations in hospital preparation rooms, and preventing the production (preparation) environment from contaminating products. The production (preparation) area must Meet the specified environmental parameter standards. In order to ensure that the performance of the dust-free workshop (area) of the production enterprise and the preparation room can continue to meet the relevant requirements of the dust-free workshop, for the newly built clean workshop (laboratory), engineering acceptance should be carried out, and the engineering acceptance should be divided into completion acceptance and comprehensive performance The comprehensive evaluation is carried out in two stages. The inspection and adjustment of the completion acceptance should be carried out in the empty state or static state. The inspection status of the comprehensive performance evaluation shall be negotiated and determined by the construction, design and construction units, and then inspected by a qualified third party. The dust-free workshops put into use should also carry out performance inspections on the dust-free workshops (zones) on a regular basis.

1.The design and construction of the clean laboratory exceed the standard

① For companies with multiple clean rooms with requirements from 10,000 to 300,000, the design and contractor will do the same in accordance with the requirements of 10,000, so that the design and construction will be much easier, and the system debugging of the clean workshop will also change. It's relatively easy.

②Improve the cleanliness level of the dust-free workshop. For example, in accordance with 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 and constructs according to 100,000. , Acceptance; the area of the dust-free workshop 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.

③Except for the decoration design of the clean workshop (laboratory) with special requirements on the process, such as extraction room, drying room, etc., the height of the dust-free workshop is generally 2.6 meters to 3.0 meters, but some companies do not know why the whole workshop is unified Built to be 4.0 meters high.

The most direct consequence of the above methods is that the investment cost of the clean room, especially the operating cost, has doubled. To improve the cleanliness level of the clean room, it is necessary to increase the number of air changes in the clean room and increase the clean air entering the clean room. Increase the volume of the clean room (including area and height), and increase the volume of clean air entering the clean room. This will increase the operating cost of the clean room, such as the cost of replacing the high-efficiency filter. Also take into account, the cost will be further increased.

Therefore, according to the different requirements of different production processes and different production processes for environmental cleanliness, the high is high, and the low is low, and 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 workshop (laboratory) system replaces the dust-free workshop 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.

2.There is a problem 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 air velocity of single-phase flow is small, and it cannot be discharged immediately after pollution occurs.

②The quality of the high-efficiency filter is unqualified, and it has not been inspected one by one when it leaves the factory.

③The 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.

④ The production personnel did not fully implement the clean work system, and the pollutants carried by themselves (such as the pollution of the clean clothes, not wearing sterile caps, masks, etc.) were accelerated to the production line.

⑤The 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. If it is non-unidirectional flow The air supply outlet is arranged on one side of the centralized air supply 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.

3.It is not advisable to use the method of sending back and sending back to the wind

Due to historical reasons, individual dust-free workshops still adopt the method of sending back and returning to the air. 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 5um, which are often measured by 0.5um to reach the standard, but when measured by 5um, it is not up to the standard.

②If it is a local one-hundred-level space, the wind speed in the work area is often very small, and it is difficult to reach the standard.

③ It is easy to cause the airflow in a certain area at a certain height to stagnate. When the upward force of the particles and the gravity counteract, it is easy to make the large particles stay in a certain space area, which is not conducive to the removal of particles, and the system generates a primary Pollution is also easy to induce secondary pollution.

④The 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. This is because:

① It is easy to cause air short circuit, so that part of the clean air and fresh air cannot participate in the function of the whole room, thus reducing the cleaning effect and the sanitary effect.

②It is easy to cause pollution particles to pollute the operating points they pass during the ascent and discharge process.

4.The number of air changes in the 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 turbulent flow or the displacement effect of single-phase flow, the amount of clean air is required in the clean room. Control and realize various parameters of the clean room, so the number of air changes in the clean room cannot be too low. For example, in a clean room with a class 300,000, the number of air changes is 12, and the data of class 10,000 can be obtained after cleaning and air blowing. After a long period of self-purification, the quality of the dust-free workshop is worrying. It can be seen that the dust-free workshop must not only achieve a certain level of air cleanliness, but also have a certain degree of anti-pollution interference ability. The size of the self-cleaning time can reflect the anti-pollution interference ability of the dust-free workshop to a certain extent.

The number of air changes in the dust-free workshop should not be too large. my country's "Code for Construction and Acceptance of the dust-free workshop" stipulates the upper limit of the air volume at 1.2 times, otherwise it will increase the operating cost. In addition, from the inspection data of some dust-free workshops, increasing the number of air changes did not result in an improvement in the cleanliness level. Instead, it proved that there were problems with the design and construction of the dust-free workshop. It was either the leakage of the high-efficiency filter or the airflow organization pattern of the dust-free workshop. unreasonable.

According to relevant regulations, the air supply volume of the dust-free workshop should be the maximum of the following three items: the air supply volume to ensure the air cleanliness level; the air supply volume calculated based on the heat and humidity load; the total air supply to the dust-free workshop The amount of fresh air given. The amount of fresh air should be the maximum of the following two items: the sum of the amount of fresh air required to compensate for the internal exhaust and maintain the positive pressure value in the room; ensure that the amount of fresh air supplied to each person in the dust-free workshop is not less than 40 per hour cubic meter.

5.The decoration design of clean workshop (laboratory) should fully consider the impact on air flow pattern and air cleanliness. Common problems are as follows:

①The return air vent of the non-unidirectional flow clean room is not far away from the working area.

②The non-unidirectional flow dust-free workshop has only one-sided return air, which increases the vortex area of the non-unidirectional flow dust-free workshop, 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. Time is even more impactful.

③The process equipment to be exhausted is not arranged on the leeward side of the dust-free workshop; the residual pressure valve is not arranged on the leeward side of the clean air flow.

6.Unreasonable selection of filter

The selection of the filter should comply with the following points: the performance of the final filter should be reliable, the efficiency specification of the pre-filter should be reasonable, and the maintenance of the primary filter and the 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. The filter area is large, the dust holding capacity is large, and the service life is long; the filter area is large, the airflow speed through the material is low, the filter resistance is small, and maintenance costs can be reduced. And the energy consumption of the air conditioning system.

7.The number of air outlets in the clean room (laboratory) decoration design 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, which often causes the number of air outlets to be inappropriately reduced. As a result, the air outlet speed increases under the same number of air exchanges, which increases the non-uniformity of the speed field. Uniformity increases or expands the vortex area.