Business Line (Mr. Zeng)
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2019-05-13 10:30:00 Editor： Yan Hong shares 0
The core of the clean room is the clean room. The so-called clean room refers to the room that controls the concentration of airborne particles. The construction and use of the clean room should reduce indoor intrusion, intervening and retained particles. Other relevant parameters in the room such as temperature, humidity, and pressure difference are strictly controlled as required. The main means of control is clean air conditioning, which is guaranteed by the building maintenance structure. However, the production of the products is done under the automatic control of the process equipment connected by electricity and pipeline.
Workshop layout and piping design
1. The layout design of the workshop includes two aspects. One refers to the layout of the factory with the preparation workshop and the layout of the surrounding workshop and other workshops. It is called the factory layout, and the second refers to the layout of the internal equipment of the workshop. , called workshop equipment layout.
2. Before starting the car plus your layout design, first collect the design basis and original data, including clear product outline and production scale, plant location and hydrometeorological address data, and then make a multi-party comparison to determine the process and layout.
3. Because the product room of the preparation plant is a special product that can prevent and cure human diseases and enhance the body's physical fitness, in addition to following the general chemical workshop layout principles, some special principles must be followed.
4. The layout of the workshop and the process flow have a close relationship with the equipment selection. When the process and equipment are changed, the civil works will be changed accordingly, and the ventilation, lighting and other projects will be affected.
5. Therefore, the layout of the preparation plant should be based on the research results of the feasibility study report to determine the product direction and scale, and design according to GMP standards.
6. The actual outdoor parameters include stability and relative humidity, outdoor wind speed and annual dominant wind direction and frequency, atmospheric pressure, outdoor atmospheric dust, and environmental conditions around the plant.
7. Indoor calculation parameters include indoor temperature and humidity base and its allowable fluctuation range, indoor air cleanliness, flow rate, noise, vibration and pressure.
8. The concentration of outdoor atmospheric dust in clean areas and polluted areas can vary by a factor of ten to several tens of times, which results in a high-efficiency filter life of 1-2 years, while some have a difference of up to 10 years, in addition, If the outdoor environment is particularly clean, if the Class 1000 cleanliness is achieved, the final filter can be used without a high-efficiency filter, but with a medium-efficiency filter or a sub-high-efficiency filter, but it is completely impossible in a contaminated area.
9. The advanced nature of the equipment has a great impact on cleanliness, especially in the production of preparations.
10. Process selection of equipment In addition to materials, it is also necessary to choose sealing, automation, linkage, to reduce operating procedures and operators, to remove sources of pollution, and equipment must be easy to clean and remove, in order to meet GMP requirements.
11. According to the investment province, fast, low energy consumption, compact process requirements, etc., the preparation plant is most suitable for the construction of a single-storey large-scale factory. If it is designed as a windowless factory, it is more ideal.
12. In the preliminary design stage, after the completion of the innumerable balance and heat balance calculation, the pipeline calculation is also carried out. The main content is to calculate the pipe diameter and select the coffin. Second, the civil engineering design of the preparation workshop
1. The significant difference between the preparation workshop and other industrial plants is that the preparation workshop has a workshop with certain cleanliness requirements. In addition to the architectural features of a general industrial plant, he must also meet the requirements of a clean workshop.
2. The clean workshop can be divided into three parts: clean production area, clean auxiliary area and clean power area.
3. Cleanrooms are equipped with cleanrooms of all levels, which are the core part of the cleanroom. It is generally considered to have entered the clean production area after passing through the shower or air chamber.
4. The clean auxiliary area includes the net, the net and the living room, and the pipe technology interlayer.
5. Among them, there are net toilets, changing clothes and shoes room, air shower room, crude oil purification and fine purification, two preparations and possible material passages, living rooms have dining rooms, lounges, drinking rooms, Miscellaneous and rain gear storage rooms and clean stamps.
6. The clean power zone includes clean air conditioning room, pure water station, gas purification station, substation and vacuum pumping room. 7. China's pharmaceutical production management regulations are the same as those of national GMP requirements. The decoration materials used in clean rooms are required to be washable, without pore cracks, and the surface is smooth and smooth, and no particulate matter may fall off.
8. The main materials used in the ceiling are reinforced concrete flat roof, steel skeleton steel mesh flat roof, light steel keel paper gypsum board, medium density plastic coated board, aluminum alloy keel glass wool decorative ceiling and so on.
9. At present, the wall materials commonly used in domestic pharmaceutical factories are white porcelain wall and paint wall. 10. Wall materials commonly used are brick stone walls and lightweight partition walls.
11. The door of the clean room is required to be smooth, smooth, easy to clean, and simple to select. The common types of doors used in domestic clean rooms are steel door steel alloy doors, steel plate doors (which can be used as fire doors) and honeycomb plastic doors developed in recent years.
12. Clean room windows, currently used are steel windows and aluminum alloy windows. The windows in the clean area are required to be tightly rigorous. The windows should use large glass windows as much as possible to reduce the dust accumulation point and facilitate the cleaning work. The window sill should be made diagonal or leveled by a clean room.
Three ventilation, air conditioning and air purification
1. The advantages and disadvantages of the drug, in addition to the direct response in terms of efficacy and safety, are also manifested in the stability, consistency and practicality of the drug.
2. In order to ensure the quality of medicines, in addition to complying with the relevant statutory standards such as the Pharmacopoeia, it is an important aspect of production in a clean environment.
3. Although the air-conditioning purification equipment is an important aspect of the implementation of GMP, it must be noted that it is only a perfection and supplement to the production equipment and production management, to prevent microbial pollution or cross-contamination alone, relying on air-conditioning purification system can not, even if Air-conditioning purification equipment may not fully meet the GMP requirements. It must be noted that when the equipment conditions reach a certain level, it must be realized through management.
4. Harmful or harmless foreign matter in the air of the production area should be minimized. Air conditioning systems can be used to supply sufficient air to remove airborne dust that may contaminate the product.
5. The air conditioning system should consider preventing new wind and return dust from entering the work area, supplying sufficient air volume to drive out airborne foreign objects in the work area, and independently managing the inlet air to meet the required temperature and humidity. Purify the intake air with a high-efficiency filter, so that bacteria and fine dust do not enter.
6. In order to ensure the quality of the drug and establish a complete quality assurance system, in 1982, the Chinese pharmaceutical company promulgated the “Guidelines for the Administration of Pharmaceutical Production”. In the course of implementation, it was revised several times. In 1992, it was revised again. In 1999, it was promulgated and implemented by the State Drug Administration. Its basic spirit and content are roughly the same as those of foreign countries.
7. “Quality Management Standards for Pharmaceutical Production” clearly stipulates that all new, rebuilt or expanded pharmaceutical factories or production workshops must be designed, constructed and produced by GMP, and only after passing the inspection by the provincial and municipal health administrative departments. Production enterprise license". The original production plant should also be combined with the production technology transformation of the enterprise, so that it may meet the GMP requirements.
8. In the non-sterile preparation process, according to the hygroscopicity of the product, and the heat load of the operator's clothing and equipment, and the economic effects, the temperature and humidity are determined. Generally, the standard is 22-28 °C in summer, 50%-60. %RH, 18-20 °C in winter (40%-55% RH for dispensing).
9. “Pharmaceutical Production Management Regulations” requirements: The general control temperature of the clean area is 22-24 ° C, and the relative humidity is 45%-60%. The production and sub-assembly of hygroscopically strong sterile drugs adopts a local low-temperature workbench. The control zone generally controls the temperature of 18-28 ° C and the relative humidity is 50%-65%. When determining the relative humidity of the room, it should be considered that the excessive relative humidity will not only make the product absorb moisture, but also prone to mold. If the relative humidity is too low, it will easily generate static electricity in the clean room (this is not allowed in the explosion-proof workshop) And make the indoor operator feel uncomfortable.
11. In terms of energy saving angle, the lower the relative humidity in summer, the greater the energy consumption. According to calculation, the number of air exchanges in the clean room is 20 times/h, the room humidity is 25°C, and when the indoor relative humidity is increased from 55% to 60%, About 15% cooling load can be saved.
12. When determining the clean room temperature humidity, it is necessary to pay attention to the process requirements, but also to maximize the energy consumption of air conditioning. 13. The manufacturing process of the aseptic preparation consists of a clean zone of 10,000 to 100 grades, and the potting process of the injection of 100 grades of cleanliness is required. Generally, a laminar flow clean cover or a stratified flow cleaner is installed in the 10,000-class workroom. Once a stream of cleanliness.
14. China's "pharmaceutical production management standards" recommended, the number of ventilation required under normal circumstances, the cleanliness of 10,000 grades is ≥ 25 / h, the degree of cleanliness 100,000 grades is ≥ 15 / h, and pointed out the number of air changes The determination should be verified based on the heat balance calculation.
15. Class 100 clean room with vertical laminar flow, room section wind speed ≥ 0.25m / s, horizontal laminar flow level 100 clean room, room section wind speed ≥ 0.35m / s. In general, you can use local laminar flow to achieve in a 10,000 or 100,000 environment.
Class 100 requirements.
The determination of the number of air exchanges required in the clean room of the pharmaceutical factory is very flexible. It has a close relationship with the equipment layout, personnel density, and the advanced level of the process equipment. It is necessary to install the room for the ordinary ampoule filling and sealing machine. The high degree of air exchange, in the case of a water needle production room in which a washing and sealing machine with an air purifying device is arranged, requires only a low number of air changes to maintain the same cleanliness.
17. In order to prevent outdoor polluted air from entering the clean room, the clean room must maintain a certain positive pressure. According to China's "Clean Factory Design Regulations", the pressure difference between the clean room and the adjacent room should be no less than 4.9Pa, and the pressure difference between the clean room and the outdoor should not be less than 9.8Pa.
18. Necklace in the dressing room and clean corridor in the working area of the aseptic preparation, as well as the aseptic operation room with different biological cleanliness levels, according to the level of sterility.
19. The rooms connected to each other should have a pressure difference of 4.9Pa or more according to the cleanliness level, and the pressure difference is small. It is impossible to prevent the gap from penetrating during strong winds or the pressure difference when the door is opened or closed. The pressure difference is too large, and it is often difficult to open the door. The ideal method is to use the air lock chamber while maintaining a reasonable pressure difference.
20. For the production of dust, toxic gases, flammable and explosive gases in the clean room, such as tablet workshop, penicillin workshop, anti-tumor drug workshop, solvent coating room, raw material medicine baking process, etc. In order to avoid the escape of harmful substances, it should maintain a relative negative pressure with the adjacent clean room.
21. The refrigeration plan shall be based on the technical requirements of the cooling source (cooling capacity, cooling capacity, cold water temperature, etc.) in the construction area (water temperature, water quality, water quantity, etc.) and the power source and heat source preparatory parties. Comprehensive analysis of various factors to determine, that is, to require better economic indicators, but also to consider local possibilities.
22. The heat and wet process includes heating, cooling, humidification and dehumidification. 23. The hot, wet exchange medium is water, steam, liquid moisture absorbent and refrigerant.
24. The hot and wet exchange equipment can be divided into direct contact type and surface type, wherein the direct contact type includes a spray chamber and a steam humidifier. Surface types include air heaters, water-cooled surface coolers and direct evaporative surface coolers.
25. Direct contact heat, wet exchange equipment is characterized by the fact that the hot, wet exchange medium is in direct contact with the treated air, usually by spraying it into the treated air.
26. Surface heat, wet exchange equipment is characterized by heat, moisture exchange medium is not in direct contact with air, wet exchange is carried out through the metal surface of the processing equipment.
27. Ordinary air conditioning air supply methods can be divided into centralized and partial.
28. In the centralized method, according to the difference of taking away indoor heat load medium, it can be divided into three types: full air type, air-water type and full water type. For air crystallization technology, only full air type can be used.
29. The purification system requires a coarse, medium and high efficiency filter. Combined with the dual requirements of air conditioning and purification, the purification air conditioning system can be divided into a centralized purification air conditioning system and a decentralized purification air conditioning system.
30 Partial purification method is suitable for the production of small batches or the use of the original plant for technical transformation.
31. At present, the most widely used is the purification treatment combined with the purification of the whole room and the local purification. This is the purification method for the production of clean technology. It can ensure a certain degree of cleanliness in the room and achieve high in local areas. Clean environment, so as to meet the requirements of production for high cleanliness environment, but also save energy.
32. One of the earliest developments in clean room cleanroom technology, and is still being used today.
33. Whole room purification is suitable for places where the process equipment is large, the quantity is large, and the indoor requirements are the same cleanliness, but this method has large investment, complicated operation management and long construction period.
34. The typical combination of clean tunnel-type full-room purification and partial purification is the current purification method, also known as the third-generation purification method.
35. Clean pipelines require process production to be automated. High-efficiency filters must be based on 0.1um dust particles to achieve ultra-high cleanliness.
36. Since the clean pipeline is cleaned by the air in the pipeline, the amount of return air is small, which can greatly save energy.
It is the development direction of clean technology, also known as the fourth generation purification method.
37. The airflow organization of the clean room is an important part in the design of the clean air conditioner, which is not only related to the temperature, humidity and airflow speed of the indoor work area, but also related to the air cleanliness.
38. Good airflow formation can achieve higher air cleanliness under a smaller system circulation air volume. 39. In the engineering design, in addition to considering the purification method, the purification air conditioning system formation and its corresponding design and system division principles and design points, special attention should be paid to the airflow organization of the clean room.
40. The distribution of air in the room is related to many factors, the main factors are the form of the air return, the number of the return air, the position and the air flow speed.
41. The airflow organization of the clean room is different from that of the general air conditioner.