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文章出处:Technology|阅读量:435|发表时间:2021-03-11
How to allow pharmaceutical companies to reasonably build pharmaceutical workshops within a certain funding budget, so that the workshops can meet GMP standards, have complete functions and reserve space for future development, is the topic we are discussing today. This article takes the pharmaceutical solid preparation production workshop as an example. Through analyzing the characteristics of a solid preparation workshop and the requirements of the GMP design of the workshop, the draft of the solid preparation production workshop design is obtained. Commonly used solid dosage forms are divided into: powders, granules, tablets, capsules, dripping pills, films, etc., which account for about 70% of pharmaceutical preparations. Compared with liquid preparations, solid preparations have the advantages of good physical and chemical stability and lower production costs.
How to set the air supply and return air outlets in the clean room of the factory?
1. For non-unidirectional flow clean rooms with high cleanliness requirements or clean rooms with a relatively large aspect ratio, the air supply form with small air volume and more air outlets should be used as much as possible; and the return air outlet should also be selected for small air volume and more return air outlets. Program.
2. For a clean room with a cleanliness of class 1000, use the form of double-sided lower return air. For clean rooms with a cleanliness level lower than 1000, when the width of the clean room is not more than 3m, the bottom return air on one side can be used; when the width of the clean room is greater than 3m, the bottom return air on both sides should be used; when the width of the clean room is large, if When the lower return air on both sides cannot meet the airflow organization requirements, a return air outlet (in the form of return air columns, etc.) should be added at 1/2 the width of the clean room to reduce the vortex area.
3. In addition, the up-sending and back-flowing air organization can be used on non-working surfaces such as clean corridors and changing rooms, but the up-sending and back-up air organization should not be used in the operation room of the clean room. If conditions permit, it is best to use the airflow organization on the non-working surface. This is because the airflow organization on the upper side and the back side has the following defects:
At a certain height, there are more large particles of 5um (because of its poor ability to follow the airflow), and the cleanliness standard is often measured by the particle concentration of 0.5um, while the particle concentration of 5um is not up to the standard. If it is a local 100-class clean room, if the upper delivery and return plan is adopted, the wind speed in the working area is often very small, which is difficult to meet the standard, and the self-cleaning time is longer. It is easy to cause a short circuit of the supply air flow, causing part of the clean air flow and fresh air. Can not participate in the dilution of the whole room. Therefore, the cleanliness and hygienic effect are reduced, and it is easy for the polluted micro-particles to pollute the operating points they pass during the ascent.
In general, the clean room is equipped with air supply and return air outlets to ensure that each area can have high clean air delivery. The return air system can quickly discharge pollutants to the outdoors. The clean room needs to be rationally laid out and piping design. Towards. In the specific planning and design of the clean room of the plant, it should be flexibly controlled according to the size of the cleanliness, the location of the process equipment and other conditions. The general principle of arranging the return air outlet is: adapt to the air outlet, cooperate with the air outlet to fully diffuse the clean air flow, fully dilute the indoor air flow, and evenly flow out of the room.