Business Line (Mr. Zeng)
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2019-05-21 13:44:18 Editor： jushong shares 0
The clean factory environment is the necessary requirement for the industrial development of China's industrial development. On the one hand, it is the objective development of the electronics industry and the precision production fields such as medicine. On the other hand, it has also become a powerful evidence for the continuous optimization of the internal structure of China's industrial industry. For the construction of clean workshops, the design and construction of the water supply and drainage system are closely related to the safety and work convenience of the entire clean workshop. Therefore, the water supply and drainage system should be given special attention when constructing the clean factory environment.
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.
42. In order to improve the temperature and humidity diffusion effect and reduce the circulating air volume, the general air-conditioned room usually adopts a highly influential airflow organization to cause secondary induced airflow, some upward airflow and certain eddy currents, and clean air flow tissue. Its role is to limit and reduce the pollution of dust particles to work, so this kind of pro-flowing airflow organization is very unfavorable for the clean room.
43. China's "Clean Factory Design Code" stipulates that the vertical laminar flow clean room airflow through the indoor section speed is not less than 0.25m / s, the United States federal standards for 0.45m / s, error 20%, under the same cross-sectional area The latter's air volume is 1.8 times that of the former.
44. The length of the self-cleaning time is related to the section speed of the airflow. The flow rate is large, and the self-cleaning time period, otherwise, the self-cleaning time is long.
45. The laminar flow clean room is fed according to the purified air. The discharge mode can be divided into a vertical laminar flow clean room, a double horizontal laminar flow clean room, and a horizontal laminar flow clean room on both sides.
46. Vertical laminar flow clean room mainly has the following types: vertical damper layer clean room, ceiling and side double cloth high efficiency filtering vertical laminar flow clean room, full hole plate top vertical vertical flow clean room, dense streamline diffuser A vertical laminar flow clean room with a vertical laminar flow clean room, a vertical laminar flow clean room with a return air at the lower part of the wall of the full ceiling, a vertical laminar flow clean room with a concentrated filter box, and a double-layer flow clean room.
47. The turbulent flow clean room airflow has the following types: full-hole plate top delivery, partial orifice plate top delivery, streamlined multi-directional pollution, control of the same direction pollution, control of reverse pollution, and meet the appropriate self-cleaning time.
48. In the vertical laminar flow clean room, the air flow velocity mainly has the following aspects: controlling multi-directional pollution, controlling the same-direction pollution, controlling reverse pollution, and meeting the appropriate self-cleaning time.
49. One of the original intentions of a typical vertical laminar flow clean room is the use of grille floors.
50. The full ceiling ventilation side grabs the lower return air vertical laminar flow clean room can save expensive grille floor and lower mezzanine. It not only reduces the height and cost, but also solves the problem of the discomfort caused by the vibration, the small parts falling into the grille floor and the grille floor.
51. The vertical laminar flow clean room in the form of full ceiling air supply can be covered with a high-efficiency filter on the ceiling, and the ceiling can be damped by a full-hole plate.
52. When the unilateral return air, the vertical laminar flow clean room width should not exceed 3m, when the double side returns to the wind, the room width should not exceed 6m. This ensures that the eddy current zone is controlled below the starting height of the working zone by 0.8 m.
53. The resistance of the return air inlet of the vertical laminar flow clean room is extremely significant for the intimacy of the streamline.
54. The flow direction of the horizontal laminar flow clean room is inconsistent with the gravity sink of the dust particles. Therefore, the cross-section wind speed of the horizontal laminar flow clean room should be greater than the cross-section wind speed of the vertical laminar clean room, generally not less than 0.35 m/s, otherwise it will Dust deposits appear.
55. The cleanliness of the horizontal laminar flow clean room gradually decreases along the flow direction of the airflow. It is generally considered that the work area with the highest cleanliness in the working area of 0.8-1.5 m from the ground is the first working area, and its cleanliness is 100 grades. Near the return air wall is 10,000.
56. The horizontal laminar flow clean room requires that the equipment should be arranged to minimize the damage to the horizontal laminar airflow.
The equipment should be placed near the return air wall.
57. In the horizontal laminar flow clean room, under the condition of ensuring laminar flow in the working area, the local high efficiency filter of the air supply wall and the local medium efficiency filter of the return air wall can reduce the number of filters, but the filter arrangement of the university The area shall not be less than 40% of the area of the air supply wall, and the area of the medium efficiency filter shall not be less than 30% of the area of the return wall.
58. The high-efficiency filter of the horizontal laminar flow clean room is installed directly in the air supply static pressure box, which is much easier to install on the top paste than the vertical laminar flow clean room, and the replacement is convenient.
59. The circulating fan of the horizontal laminar flow clean room can be placed at the top or bottom of the clean room. When the building level is low, it is also unknown on one side of the clean room.
60. After the airflow from the horizontal laminar clean room is sent out from the air supply wall, it must pass through each working surface. The amount of dust on the windward side must affect the dust concentration of the air on the leeward side. Therefore, it is necessary to strengthen the personal purification.
61. It is generally believed that a horizontal laminar clean room should be provided with a personal purification device such as a shower room.
62. The cost of the horizontal laminar flow clean room is lower than that of the vertical laminar flow clean room, and the lamps are arranged and installed conveniently.
63. The uneven distribution theory of uneven distribution theory still assumes that the dust is uniform and stable, but the dust particles are unevenly distributed.
64. The uneven distribution of dust particles in the theory of uneven distribution does not mean the uneven distribution of each point, but refers to the uneven distribution of the regions, that is, the regional concentration difference, which is calculated according to the uneven distribution of each point. Possibly, it is not necessary, this matter is the basis of the uneven distribution of the clean room.
The requirements of the four professions and their relationship with each other
1. High purity gases required for clean room process production include: high purity hydrogen. Oxygen, nitrogen, chlorine, nitrogen, helium and compressed air.
2. The amount of hydrogen and nitrogen is the most, and the purity is made by semiconductor devices and integrated electric cesium in the electronics industry. The highest risk is hydrogen and oxygen.
3. The main considerations for high purity gas in the overall design are gas production (source), purification, transport and safety measures.
4. The main function of the clean room gas inlet chamber is to control the gas sent to the plant, including cutting, decompression and pressure regulation, measuring the flow rate of the gas, temperature and other parameters and, if necessary, detecting the purity of the gas.
5. The gas inlet chamber should be as close as possible to the gas point in the clean production area to shorten the pipeline, reduce pollution and facilitate management. 6. The high-purity gas supply chamber of the clean workshop should not be placed in the clean production area to reduce oil pollution and pollution. At the same time, it should be placed on the bottom layer for the convenience of transporting orange cylinders.
7. The electrical design of the clean room includes the usual transportation and the use of fire during the three aspects of strong electricity, weak electricity and automatic control.
8. Strong electricity includes power supply, power and lighting, and weak parts include broadcasting, telephone, closed circuit television, alarm and fire protection, automatic control including temperature, humidity and micro-positive pressure control, freezing station, air compressor station, pure water and Control of gas purification stations and automatic fire extinguishing facilities.
9. When the lighting fixture is arranged on the chandelier, it should be arranged with the air outlet, and the process installation should be coordinated. The openings of the three parts on the ceiling can not be arranged arbitrarily.
10. In addition to the uniform layout of the lighting, it is also necessary to pay attention to the layout and operation of the process equipment and the need to open the air outlet.
11. When each device is switched on and off, try not to set the switch in the 10,000-level area, and set it in the buffer when needed.
12. Drainage in clean workshops is also a very important issue. Poor arrangements will affect and contaminate the clean room.
13. Generally speaking, it is 100 class, and no floor drain should be set in the 10,000-level area. If special needs can be set, the floor drain can be set.
14. Since there are different levels of clean areas in the preparation workshop, and different clean areas need to work together, it is generally necessary to set up a telephone, and determine the number of units according to the size and position of the clean area.
15. According to GMP regulations, an alarm device should be installed in the clean room, and an alarm signal will be issued when a fire hazard occurs.
16. The relationship between the preparation process and the civil works is closer than other processes and civil works. When not knowing, it should be closely coordinated with the civil engineering and ventilation departments.
17. After the process and process equipment are selected, it is necessary to meet the conditions of the process and to take care of the arrangement of the upper facade of the civil works, and to increase the unique tube position of the door, security door, stairwell, bathroom and preparation plant.
18. Preparation long clean room air conditioning to return to the wind form, top send top back, top send back, top send back.
19. In the design of clean workshops, a series of auxiliary processes such as aseptic compressed air, aseptic clothing treatment, indoor and appliance, and pipeline disinfection are extremely important and an important part of ensuring the implementation of GMP requirements.
20. The process uses oil-free air compressor and freeze dryer, no need for dryer, adsorbent.
21. Since the dust in the clean room is from the construction materials, it accounts for 5%, and the ventilation and ventilation is 15%, and the people from the people account for 80%.
22. In order to increase the dust brought in by the factors of your small number, the requirements for the overalls are also very prudent.
23. Sterile clothing should be made of nylon-free or silk-free products. The disinfection methods of these two garments are also different.
24. Sterilization in a sterile room. In the past, a safe UV lamp was used, and the sterilization power of the single-UV lamp was reduced with time.
Five fire, safety, industrial hygiene and energy saving
1. The fire protection requirements of the workshop should meet the relevant provisions of the National Code for Fire Protection of Building Design and the Code for Design of Clean Plants.
2. Measures should be taken according to the characteristics of the two specifications and the amount of work to create conditions for preventing fire, delaying and facilitating evacuation and fighting.
3. The main hazards of static electricity are: affecting efficiency and product considerations in production, personal labor protection in health, and safety, fire, explosion and other accidents.
4. One of the effective ways to eliminate the cause of electricity is to use the materials that are disconnected from electricity to make the floor of the clean room, the various layers and the shoes of the operators.
5. In order to make the original static electricity of the human body leak to the earth through the shoes and the working ground as soon as possible, the conductivity of the working ground plays an important role, so the antistatic performance of the ground is required.
6. The clean room veneer material should be made of low-charge materials, that is, decorative materials with good electrical conductivity and reliable grounding measures.
7. An effective method to eliminate static electricity when grounding. This method is simple, reliable, and does not require a large cost. The grounding must comply with the requirements of the safety technical regulations.
8. One of the effective ways to reduce the production of static electricity by electrical materials during chemical processing. It coats the surface of the material with a special surface layer and uses antistatic substances.
9. The ions in the atmosphere can be divided into light ions, medium ions and heavy ions.
10. A positively charged light ion is called a positive ion, and a negatively charged light ion is called a negative ion.
11. There are many sources of noise. In terms of industrial noise, there are mainly three kinds of aerodynamic noise, mechanical noise and electromagnetic noise.
12. The main noise sources in air-conditioning engineering are ventilators, chillers, mechanical ventilation cooling towers, etc. The noise of the ventilator is transmitted from the air duct to the room. The vibration and noise of the equipment may also pass through the building structure.
13. Due to the certain noise requirements in the clean room, the clean air conditioning system should have noise control measures in addition to the cleanliness and source humidity requirements. One of the important means is the noise reduction of the ventilation system and the vibration reduction of the equipment. .
14. The Code for Cleanroom Design requires that the noise level in the clean room should meet the following requirements: During dynamic testing, the indoor noise level should not exceed 70dBA. When the air state is tested, the turbulent clean room should not be larger than 60dBA, and the laminar flow is clean. The room should not be larger than 65dBA.
15. The main noise of the air conditioning system is the ventilator, which is important in the low range, about 200-800 Hz. The noise level of the ventilator, usually expressed in terms of sound power level.
16. The muffler is the main method for controlling aerodynamic noise. It is a device that prevents sound from propagating while allowing airflow. The muffler is mounted on the airflow path of the aerodynamic device, which can reduce the noise of the setting.
17. With the increasing number of purification air-conditioning projects, energy consumption is also increasing, and various ways must be sought to do energy-saving work, so that the energy consumption of the output value of 100 yuan is minimized.