Large infusion dust-free clean pharmaceutical cleanroom

Large infusion packaging containers mainly include glass bottles, plastic bottles and plastic bags; PVC soft bags have good stability at room temperature, are easy to transport, are relatively soft, and are not easy to enter air during use, but have poor compatibility , Water vapor permeability is also high; semi-hard plastic bottles made of PP and PE...
Text label: Large infusion clean pharmaceutical cleanroom, large infusion clean workshop

Large infusion dust-free clean workshop


Large infusion packaging containers mainly include glass bottles, plastic bottles and plastic bags; PVC soft bags have good stability at room temperature, are easy to transport, are relatively soft, and are not easy to enter air during use, but have poor compatibility , The water vapor permeability is also high; although the semi-rigid plastic bottles made of PP and PE do not have the problem of PVC bags, but because they are semi-rigid, they need air into the holes like glass bottles during infusion, and there are also polluted danger. The multi-layer co-extrusion film adopts the multi-layer co-extrusion technology and is manufactured in a clean environment using a special process. It is composed of PP and PEBS in different ratios. It is extruded from a closed tube in a clean environment. The film bag composition will not enter, and the inside of the film cylinder is filled with 100-grade clean air. In addition, the high-temperature extrusion process ensures the surface of the film. Sterility, can meet various requirements of infusion bags, can be sterilized at 121 ℃, soft, transparent, and low water vapor permeability.


The glass bottle filling process consists of water production, pretreatment of empty infusion bottles, treatment of rubber stoppers and isolation films, ingredients and finished products. Before filling and sealing, 4 production paths are carried out at the same time. The solvent preparation of injection, Treatment of empty infusion bottles, treatment of rubber stoppers, preparation of infusion agents; in order to remove impurities such as additives in the rubber stopper, it is necessary to clean the rubber stopper, which can be carried out on a rubber stopper cleaning machine. After the purified water is boiled, the impurities of the rubber stopper are removed, and then it can be used after cleaning with purified water and water for injection. The requirements for raw and auxiliary materials, production equipment and production environment are higher, especially the condition control of the production environment, such as the filling, filming, and plug-turning processes of the infusion agent, and the environment is required to be local level 100. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for large infusion dust-free workshops and clean workshops.














Infusion filling of non-PVC soft bags in clean workshops generally starts from bag making, unwinding → printing → shape sealing → trimming → interface feeding, positioning → interface sealing → upper bag sealing → final sealing → bag output → bag storage → input Bag→vacuum or nitrogen inlet→filling→capping→outlet bag; bag making, filling and sealing are completed on a mechanical device in a controlled environment of class 10000 (filling and sealing are carried out under the protection of local 100-class laminar flow) . The difference between the plastic bottle filling process and the glass bottle filling process lies in the bottle processing process. The plastic particles are injected into the preform, the inner and outer caps and the rings. The preform is blown to form a plastic bottle, and then the bottle is washed, filled, and capped. , add the rings to form the finished product.
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GMP workshop for tablet coating

The GMP workshop enters the production site to check whether there is a 'clearance certificate' for the last production, and whether there is a signature of a quality inspector or inspector; according to the relevant cleaning standard management regulations, check the post environment, on-site sanitation and cleanliness, check dry Humidity thermometer, differential pressure gauge, confirm temperature, humidity and pressure...
Text label: GMP pharmaceutical cleanroom installation, GMP workshop design, GMP tablet pharmaceutical cleanroom

GMP workshop for tablet coating


The GMP workshop enters the production site to check whether there is a 'clearance certificate' for the last production, and whether there is a signature of a quality inspector or inspector; according to the relevant cleaning standard management regulations, check the post environment, on-site sanitation and cleanliness, check dry Humidity thermometer, differential pressure gauge, confirm that the temperature, humidity and differential pressure meet the process requirements, the temperature is 18-26 °C, the relative humidity is 45%-65%, the differential pressure and the inner corridor should be relatively negative pressure, the standard is greater than 5Pa; The temperature is 24-32°C, and the relative humidity is 45%-65%. If it does not match, please contact the air-conditioning post for adjustment. Check whether the balance is clean and sensitive, whether it is within the inspection period, and if any problems are found during use, contact for maintenance in time, and the use time cannot exceed the period of the certificate.


Check the mesh number and wear of the screen according to the process prescription, and replace it in time if it is broken; loosen the fastening screws of the oscillating screen and open the upper cover of the machine to check whether there is any debris in the machine and whether it is clean. The screen is installed flat, close the top cover and tighten the fastening screws, and finally check whether the outer wall of the fuselage meets the requirements; turn on the power and start the button, check whether the machine is running normally, whether there is noise, and whether there is leakage, and confirm that it is correct , turn off the start button; check whether there are obstacles around the machine, and other items are not allowed on the machine; check and adjust the safety guards, and check the workers and appliances required for production; check whether the quartz heater and hot air system are well insulated and grounded The zero connection is good, and the electric heating tube must not touch the pot body. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and dust-free workshops.














Set the program, preheat the plain sheet first, set the time to 10min, set the inlet air temperature to 50-75℃, set it to positive ventilation; adjust the flow rate of the peristaltic pump, set it to 0.2mm, and turn on the steam Valve and compressed air switch, steam pressure and compressed air pressure are both greater than 0.4MPa; press manual build, enter the manual operation program, start the homogenization, enter the preheating stage, the pot speed in the preheating stage is maintained at 4r/min, if the tablet bed The temperature of the machine has reached 40 ℃, first click on the compressed air and then click on the spraying to enter the spraying stage; after the spraying program is carried out for 20min, adjust the speed to 5-6r/min, after the program is carried out for 30min, then adjust the speed to 6- 8r/min, and adjust the scale of the peristaltic pump to 0.3mm. After the program runs for 60min, adjust the speed to 8-10r/min, and adjust the atomization pressure to 0.3MPa. During the coating process, keep the outlet air temperature at 45- 55°C, adjust the inlet air temperature at any time according to the height; after spraying the coat, turn off the hot air blower and steam valve, and continue to run for 10 minutes for rolling and cooling. After the film feels dry and the surface appears bright, stop the exhaust fan and stop the package Take out the slurry suction filter of the peristaltic pump from the pot, close the compressed air and the ball valve of the peristaltic pump, and hang the tablet output bucket; after the coated tablets are out of the pan, put them into a stainless steel bucket with a clean cloth bag, and put them in the middle of the bucket. Station staff face to face handover.
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Clean workshops are widely used in modern production, food, medicine, machinery industry, etc. will use clean workshops. So today, let's take a look at the clean workshop decoration and production equipment installation and clean workshop decoration quotation list with sz-pharma editor~ 1. Clean workshop decoration and production equipment installation Clean workshop decoration materials: heat insulation sandwich panel, purified aluminum material , purification lamp, pvc floor, floor paint. Clean pharmaceutical cleanroom decoration equipment: air shower room, transfer window, clean workbench, FFU fan, high-efficiency air outlet, air conditioner, clean shed, laminar flow hood, etc. Before unpacking the clean workshop decoration purification equipment on site, it should be stored in a relatively clean environment, and attention should be paid to moisture-proof. The outer packaging of the equipment should be removed in a designated uncontrolled environment (except for biological safety cabinets), but the inner packaging should not be removed or damaged. The inner packaging of the equipment should be vacuumed from top to bottom in a controlled environment in the front room of the entrance, cleaned, and then removed. The outer packaging film of the equipment should be peeled off in order from top to bottom. When the equipment is transported to the site and the inner packaging is unpacked, the packing documents, accessories and pharma machinery should be checked and the unpacking acceptance record should be filled out, and then the inspection should be reported to the supervising engineer. Installation should begin immediately after unpacking the device for inspection. When the fan base of the purification equipment with a fan is softly connected to the box, the base should be erected and fixed during transportation, and then put down after being in place. The installation of purification equipment should be completed in the interior decoration of the clean workshop and the construction and installation of the purification air-conditioning system, and it should be thoroughly cleaned and wiped, but the pharma machinery connected to the enclosure structure or its exhaust and drainage pipes must be constructed at the same time as the enclosure structure. When it is connected to the solid protection structure, the arc transition should be made, the radius of curvature should not be less than 30mm, and the joints should be densely cleaned to ensure strict cleaning. The supply, return and exhaust (water) of the equipment or its pipelines should be closed before the equipment or its pipelines are installed, after installation and before the clean workshop is put into operation. The ground on which the equipment is installed should be level and flat, and the equipment should keep its vertical axis vertical and horizontal axis horizontal after the equipment is installed in place. A vibration isolation layer should be placed between the airlock with a fan or the air shower and the ground, and the gap should be sealed with sealant. The laminar flow hood with the fan is directly installed on the upper leaf of the ceiling, and the contact parts between the box rest and the ceiling plate should have anti-vibration measures such as vibration isolation pads, and the gap should be sealed with sealant. For equipment with a fan, the fan should be tested after installation. The rotation direction of the impeller should be correct during the test run. The test run time should be determined according to the requirements of the technical documents of the equipment. When there is no regulation, it should not be less than 1h. 2. List of clean workshop decoration quotations: Class 10 ≥ 100 ≥ 1,000 ≥ 10,000 ≥ 100,000 ≥ 300,000 ≥ 1 million The cleanliness of a million-level clean workshop seems to be low. In fact, it is equivalent to ordinary decoration. Strictly speaking, it is not a level. 1. Generally speaking, the price for a class 300,000 to 100,000 clean room is about 1,000 yuan/㎡; 2. The price for a class 10,000 clean room is about 1,000 to 2,000 yuan/㎡; 3. The price for a class 1,000 clean room is about 5,000 yuan. 4. The quotation for the decoration of a class 100 clean workshop is about 8,000 yuan per square meter. After all, this type of sterile workshop is often used in places that require isolation such as surgical transplantation, and has high requirements for decoration. 5. The aseptic and clean workshops above grade ten have high requirements for decoration companies and higher quotations. Such workshops are often used in some industrial semiconductors. 3. Factors affecting the quotation of clean room decoration 1. Industry: The cost per square meter of a clean room factory in a clean room actually depends on which industry it belongs to, and the prices of different industries have certain differences.
Different industries have different requirements. On-site purification plants sometimes require heat preservation and moisture protection, and sometimes require protection from electrification. 2. Purification area: any industry is designed and constructed according to the site area, so the area is one of the reasons that affect the cost. 3. Design and separation of factories: Purification factories are not only manufacturing factories, but also have high requirements. Many auxiliary factories such as sterilization factories and packaging factories are needed. The separation of each factory will consume engineering materials, which will naturally affect the price. . 4. Selection of material consumables: Needless to say, what kind of purification material should be selected needs corresponding price. Some companies are particularly demanding, and if they need good materials, the price will of course be high. 5. Air conditioning system: The clean air conditioning system is used to maintain the temperature and humidity, wind speed, pressure, cleanliness and other parameters required by the clean room.
Enterprises need to choose the appropriate auxiliary system according to their own investment budget and construction needs, and the price of the selected air conditioning system varies. The engineer first measures the size of the site to make the plan drawings, and according to the specific conditions of the project, taking into account the economic affordability of the enterprise, comprehensive various factors to decide what purification plan to adopt. According to the drawing design, the specific material quotation (including ceiling, next door, floor, air conditioner, air shower, etc.) was prepared, which met the production and use requirements of the enterprise, and designed a reasonable project cost, economical, energy-saving and practical plan. sz-pharma focuses on the construction of clean workshops in the food industry, biomedicine, cosmetics industry, electronics industry, medical equipment, optical semiconductors, etc. The cumulative construction area exceeds 100,000 square meters, and a large number of cases under construction can be visited! sz-pharma Qualification: Construction Engineering General contracting of construction, professional contracting of fire protection facilities engineering, professional contracting of building decoration and decoration engineering, professional contracting of electronic and intelligent engineering, professional contracting of construction electromechanical installation engineering! For engineering consultation, please call: Looking forward to cooperating with your company!
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In recent years, more and more attention has been paid to clean technology. In addition to building new dust-free workshops, many industries have also transformed and upgraded the original workshops, so that the workshops can meet the environment required for product production (Produce). space. Moreover, with the development of technology, clean room decoration has been gradually integrated into all walks of life. So, what industries will use clean room decoration? At present, the dust-free workshop industry involves the following: electronics industry, electronic semiconductors, precision instruments, etc. sz-pharma will talk about it below. 1. Industries that need dust-free workshops 1. Electronic industry Some electronic industries that attach importance to precision instruments (appliance) and integrated electronics have paid more and more attention to their cleanliness and dust-free properties. Therefore, the use of clean room decoration rooms in the electronics industry can bring good public praise and benefits to the company. 2. Due to the food safety issues in the food industry in recent years, the cleanliness of food has also been paid attention to, and clean room decoration rooms have gradually developed in the food industry, especially in food processing plants and food such as fruit, breakfast and dinner. shop. Dust-proof pharmaceutical cleanroom refers to controlling the cleanliness and temperature and humidity of the atmosphere that products (such as silicon chips, etc.) come into contact with, so that products can be produced and manufactured in a good environmental space. The design and construction process of this environmental space can be called purification engineering. 3. Biopharmaceutical industry Drugs are special commodities used for prevention, treatment of diseases, recovery and adjustment of body functions, and their quality is directly related to human health and safety. The purification plant is a basic supporting industry with a very wide range of application industries. The precision and dust-free requirements of different grades are also quite different. If some medicines are contaminated or cross-contaminated by microorganisms, dust particles, etc. during the manufacturing process, unexpected diseases and hazards may occur. Therefore, biopharmaceuticals are generally carried out in clean rooms, especially the industry of filling injections, which should meet the standard of class 100 clean rooms. 4. Other industries In addition to having a great role in the electronics industry, biopharmaceutical and food industries, the clean room decoration room has a great role in the following industries. At present, the clean pharmaceutical cleanroom decoration engineering industry involves the following: Electronic industry: electronic semiconductor, precision instrument mobile phone backlight chip production, integrated circuit clean room automobile manufacturing disk manufacturing workshop, etc. Medical industry: medical pharma machinery, pharmaceutical production, biopharmaceutical and other food industries: Dairy, Juice, Salt, Brewery, Meat Processing, Baking, Bakery, Betel Nut Factory, Seafood, Seasoning Pack, etc. Daily Cosmetics Industry: Paper Skin Care Products, Cosmetics, Daily Laundry Products, etc. Printing and Packaging Industry: Precision Technology Printing Factory, High-end Gift Packaging, High-end Tobacco and Wine, Import and High-end cars and other optical optoelectronic industries: semiconductor laser led/Icd lighting LCD display led chips nano-processing optical glass infrared sensor lidar technology light-emitting diodes and other integrated circuits Chemical industry: pharma machinery lead-acid battery capacitor wireless charging technology, etc. electroplating Pharmaceutical factory sterile reproduction medical pharma machinery: medical pharma machinery operating room cultural relics warehouse: museum cultural relics room Xuzhuang Xu material: nano-functional paint building Xu material coating spraying workshop furniture paint room. ... 2. Preparations before the decoration of the dust-free workshop 1. It is necessary to understand a series of parameters in advance to reduce unnecessary troubles. The things to be understood include personnel, workshop area and real estate. 2. Pay attention to the level of decoration and build according to the drawings. 3. When decorating, in addition to looking at the design and quotation, we should also pay attention to its engineering and services. Through the above introductions, I believe that everyone should know which industries need clean room decoration and some preparations. If there is demand, you can find professional merchants for design and decoration, so as to better meet the needs of the industry. need. Most of the purification workshops, especially the clean workshops used in the electronics industry, have strict requirements on constant temperature and humidity, which not only have strict requirements on the temperature and humidity in the workshop, but also have strict requirements on the fluctuation range of temperature and relative humidity. . Advantages of clean room: simple structure, low cost of system construction, and easy expansion of clean room. In some special-purpose places, a clean workbench can be used together to improve the level of clean room. 3. The benefits brought by the production of clean room decorations With the development of computer, microelectronics and information technology, the rapid development of the electronics manufacturing industry has been promoted, and the development of clean room decoration technology has also been driven. To meet higher requirements, the design of dust-free workshops in the electronics manufacturing industry is a comprehensive technology. Only by fully understanding the characteristics of clean workshop decoration design in the electronics manufacturing industry, the design is reasonableOnly in this way can the defective rate of products in the electronic manufacturing industry be reduced and production efficiency be improved. The article refers to know which industries need clean room decoration
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