In pharmaceutical plants, compressed air is mainly used in filling machines in liquid preparations, granulators in a solid preparation, a granulator, a filling machine, a packaging machine, a printing machine, and an extraction tank in an extraction process, in addition to compressed air. It can be used for testing pilot gas, material conveying, drying, purging, pneumatic instruments, automatic control gas, etc. There are two kinds of commonly used compressed air. One is a general oil-lubricated compressed air system for the pneumatic components of the instrument. It is not in direct contact with the drug. The other is the oil-free compressed air system that is in direct contact with the drug. Since the quality of compressed air in direct contact with pharmaceutical production directly affects the quality of the product, the most commonly used drug manufacturers are oil-free compressed air systems. In order to ensure the quality of compressed air, it is extremely important to take strict purification measures on compressed air. At the same time, the compressed air system needs to be verified to prove that the system meets the production requirements and passes the GMP certification inspection.
1 Compressed air 1.1 defines compressed air, that is, air compressed by an external force. The air has compressibility. The air is compressed by the air compressor to reduce the volume of the air. The air after the pressure is increased is called compressed air.
1.2 Principle Air has a certain amount of space, but it does not have a fixed shape and volume. When the pressure is applied to the air in the closed container, the volume of the air is compressed, and the internal pressure is strong. When the external force is withdrawn, the air will return to its original volume under the action of internal pressure. If there is an object that can move in the container, when the air returns to its original volume, the object will be pushed outward by the pressure of the air inside the container.
1.3 Features Compressed air is an important source of power. Compared with other energy sources, it has the following obvious features. Clear and transparent conveying is convenient. No special harmful properties. No fire hazard. Not afraid of overload. Working air can be indispensable everywhere on the ground in many adverse environments.
Compressed air is widely used in production and life. For example, the compressed air is blown into the ball, and the harder the football is, the harder it is; the tire can be subjected to a certain amount of weight by driving a compressed air tire; in a large car, the compressed air is used to pressurize the water with a compressed air switch car and a brake hydraulic press. In the factory, compressed air is used to start the hammer in the iron engine mine, which can drive the wind and drill holes; it is used to transport liquid and granular objects. The atmospheric pressure in the atmosphere is 0.1 MPa and the desired pressure can be achieved after being pressurized by an air compressor.
Compressed air is the second largest power source after power and a multi-purpose process gas source. Its application range covers petroleum, chemical, metallurgy, electric power, machinery, light industry, textile, automobile manufacturing, electronics, food. , medicine, biochemistry, national defense, scientific research and other industries and sectors.
2 Gas source requirements for pharmaceutical compressed air 2.1 pharmaceutical production Generally speaking, the gas source quality level for pharmaceutical production should meet the requirements of 2001) (1) and general compressed air quality standards (GB/T132771991), ie dew point ~40C solid particles. The diameter is 0.1xm, the oil content is mg0.1mg/m3. The quality standard and quality grade stage of compressed air, this stage contains 3 precision filters and 1 refrigerating dryer.
The regulations are shown in Table 1. 3.1 Requirements for compressed air volume Table 1 Quality standards and quality levels of compressed air The amount of gas used depends on the consumers of the air. Grade pressure dew point (dryness and wetness) / c residual dust content / (mg / m3) residual oil content / (mg / m3) (achieved by a dryer) (achieved by a filter) (through the filter to achieve ) Level 1 - 700.1 (corresponding to a particle size of 0.1 m) 0.13 to 2050 (corresponding to a particle size of 5, the method is to add all the air consumption of the machine equipment and the connected process. In addition, leakage, wear and future use) The addition of gas must also be taken into account. The current air demand is tested by summing the air consumption of all connected equipment. The supply of compressed air is based on the current conditions of use, and the compressed air of the expansion gauge 2.2 is mixed. The appropriate margin required for the influence of the foreign matter is considered in the device. The foreign matter mixed in the compressed air, such as lubricating oil, water vapor, dust, etc., is likely to cause the following adverse effects: the oil vapor mixed in the compressed air is concentrated to a certain extent. A flammable and explosive source is formed, and an organic acid is formed after the lubricating oil is vaporized, which easily corrodes the inner surface of the compressed air pipe and the pneumatic components.
The tiny particles (such as dust, rust, etc.) mixed in can easily damage the pneumatic components. Blocking the orifice is more serious and it is very easy to cause serious pollution to the material.
The moisture mixed in the compressed air will be saturated and precipitated at a certain temperature and pressure, and the compressed air will have a serious influence on the quality of the material when it comes into contact with the material.
Excessive temperature of the compressed air can also cause aging of seals, hose materials, diaphragms, etc. of the air compressor system.
Therefore, when the compressed air is transported to the point of use, it must pass the purification process such as cooling, degreasing, water removal, and removal of solid dust particles to meet the GMP requirements.
3 Compressed air purification system for pharmaceuticals The compressed air purification system can also be called the air pressure post-treatment system. The process is shown in Figure 1. The compressed air is discharged from the compressor and then enters the air-pressure storage tank after being simply processed. After buffering, it begins to enter the air-pressure post-treatment compressed air purification system. 2 The whole process of the compressor compressor consists of the intake system, the main engine, the gas supply system, and the oil and gas separation system.
The process of intake air passing through the filter through the butterfly valve to the suction port of the compressor main unit is the intake process. The air intake system is mainly composed of a filter and a butterfly valve.
The compressor main engine compressor main body is composed of a pair of yin and yang rotors and bodies. The working process can be divided into three stages, namely the suction stage, the compression stage and the exhaust stage.
3.2.2.1 Intake phase The screw compressor adopts the axial suction of the end face. Once the meshing line between the inter-grooves enters the suction port at the meshing point of the end face, it starts to inhale. As the rotor rotates, the meshing line extends toward the exhaust end, and more and more air is drawn in. When the end face profile exits the suction port, the inhalation phase ends. The inhaled air is in a closed cavity made up of a female and a male rotor and a body.
In the compression stage, the closed cavity formed by the female and male rotors and the body continues to rotate with the rotor, and its volume is continuously reduced as it moves toward the exhaust end, so that the gas is compressed. At the same time, lubricating oil is injected into the closed chamber.
3.2.2.3 When the anode rotor tooth reaches the exhaust port during the exhaust phase, the volume of the closed chamber reaches the minimum compressed air and is discharged together with the lubricating oil, and the gas mixture passes through the check valve.
3.2.3 Gas supply system The compressed gas and oil discharged from the main engine enter the oil separator through the check valve. This process is called the gas supply process, and the gas supply system consists of a check valve and a pipe.
3.2.4 Oil and gas separation system After the mixed gas entering the separator is separated, compressed air is supplied to the user.
3.3 Oil-water separator Oil-water separator is used to separate the condensed moisture and oil impurities in the compressed air, so that the compressed air is initially purified. The working principle of the oil-water separator: when the compressed air enters the oil-water separator, it produces a sharp change in flow direction and speed and then relies on inertia; it separates the oil droplets and water droplets whose density is larger than that of compressed air. After the compressed air enters the separator body from the inlet, the air flow is first blocked by the baffle, and then reversed and then rises upward to produce a circular rotation. In this way, water droplets and oil droplets are separated from the air under the action of centrifugal force and inertial force and settled at the bottom of the body, and the bottom valve 定期 is periodically opened to discharge oil droplets and water droplets. The initially purified air is sent from the outlet to the gas storage tank.
The C-class centrifugal oil-water separator has a filtration precision of 3xm, a water removal rate of >99%, and a degreasing rate of 40%. It is mainly used as a separator for the rear cooler and a pre-filter for the refrigerating dryer.
3.4 Freeze dryer Freezer dryer working principle: humid high temperature compressed air flows into the pre-cooler to dissipate heat, and flows into the heat exchanger to exchange heat with the cold air discharged from the evaporator to make the compressed air entering the evaporator The temperature is lowered.
The compressed air after heat exchange flows into the evaporator, and the heat exchange function of the evaporator is exchanged with the refrigerant. The heat in the compressed air is taken away by the refrigerant and the compressed air is rapidly cooled. The moisture in the humid air reaches a saturation temperature and is quickly condensed and condensed. The water is agglomerated to form water droplets. The high-speed rotating ice is separated from the air by a unique gas-water separator. The water is separated from the automatic drain valve after separation. The air pressure dew point after cooling is as low as 2C. The cooled cold air flows through the air for heat exchange, and exchanges heat with the hot humid air of the inlet. The cold air exchanged by the heat increases the temperature by absorbing the heat of the inlet air. At the same time, the compressed air is again heat exchanged with the high temperature refrigerant through the secondary condenser of the refrigeration system, so that the temperature of the outlet is sufficiently heated to ensure that the outlet air line does not condense.
At the same time, the cold source of the outlet air is fully utilized to ensure the condensation effect of the refrigeration system to ensure the quality of the outlet air.
3.5 Main Line Filter The T-Class Air Line Filter can filter liquids and solid particles as small as 1xm to a minimum residual oil content of only 5x10-7 with traces of moisture, dust and oil mist. It is used for pre-treatment of the post-stage A-stage filter of the adsorption dryer to further improve the air quality.
3.6 Oil mist filter A grade ultra-efficient degreasing filter can filter liquids and solid particles as small as 0.01 xm, achieving a minimum residual oil content of only 10+, and almost all moisture, dust and oil are removed. After use in a dryer, it ensures that the air is free of oil.
3.7 Air terminal sterilization precision filter Air precision filter as a high-precision network filter, its role is to ensure that the filtered air reaches the sterility requirements. The air-end sterilization precision filter element is made of PTFE membrane and PTFE membrane, which has strong hydrophobicity and high filtration precision (filtering precision 001ixm, except oil mist rate 99.9999%), pressure reduction, high temperature resistance. It has the characteristics of long service life and is an ideal and reliable filtering device for filtering out bacteria and phage in the air.
3.8 Storage and Transportation of Compressed Air For the storage and transportation of compressed air after filtration and purification, the role of compressed air storage tank is to reduce flow pulsation and store compressed air, which can compensate for the instantaneous consumption of compressed air gas to avoid different degrees. The compressed air frequently fluctuates and starts, and has the functions of water removal and sewage discharge. A gas storage tank should be installed between the compressor and the drying equipment, and between the purification equipment and the network equipment.
In the specific use, the pipeline should meet the requirements of the national standard compressed air station design specification (GB50029-2003). For the shut-off valve of the pipeline with small water vapor content, it is recommended to use stainless valves for compressors and gas storage tanks. Stainless steel pipes must be used for pipes between freeze dryers and gas distributors: stainless steel pipes are used to ensure the quality of compressed and purified compressed air for drying and purification pipelines requiring less than 1 xm of dust. Compressed air system pipes in the pharmaceutical industry are generally made of stainless steel pipes of sanitary grade 316L. 3.9 Compressed air line disinfection Connect the piping of the pure steam generator to the compressed air line. Close (except for the farthest point of use of compressed air) Each compressed air uses point valve â–¡, open the valve at the farthest point of use of compressed air â–¡ start pure steam generator, open pure steam valve â–¡ through the pipeline to the compressed air system through the pure circulation Steam disinfection for 30min. After disinfection for 30min, open each point valve and blow dry for 30min. 4 Purify compressed air verification 4.1 Installation Confirmation Installation confirmation is to check and confirm that the installation of the equipment meets the design requirements, and the equipment information and documents meet the GMP management requirements.
4.1.1 Power supply condition 380±10%) V, 50Hz, insulation resistance >1MQ and good grounding.
4.1.2 The evaluation criteria for the installation of the safety valve shall be verified and verified. The pressure is greater than 0.8MPa automatic pressure relief.
4.1.3 Compressed air storage tanks Confirm that the compressed air storage tanks should obtain the pressure vessel use permit issued by the Municipal Bureau of Quality and Technical Supervision and within the validity period.
4.1.4 Installation and acceptance evaluation of the filter The standard installation sequence is C-class centrifugal oil-water separator 3ixm, T-class air line filter 1 xm, A-class ultra-efficient degreasing filter 4.1.5 Pipe connection is correctly according to the system The process is checked by soldering and must not be threaded.
4.1.6 Pipe installation The installation of the pipeline and the compressed air delivery pipeline and sampling points are consistent and firm and leak-free.
4.1.7 Valve switch on the system pipeline Flexible, leak-free sanitary grade 316L stainless steel ball valve.
4.1.8 Pipe material 4.1.9 Pipe welding must be automatically welded. At the same time, the number of endoscope inspections must be no less than 20% of the total welding points. The welding position should be marked on the welding raft and documented. The welder requires a qualification certificate for the welder.
4.1.10 Pipe finish finish requirement 矣0.6xm (construction party must provide proof).
4.1.11 Use the gas point number to check whether the actual gas point is consistent with the crepe paper according to the system.
4.1.12 Compressed air pipeline pressure test, passivation 4.1.12.1 Pipe pressure test design pressure of more than 115% pressure test, dwell time is not less than 60min. Pressure loss is less than 0.03MPa. 4.1.12.2 pipe passivation purified water pre-flush i The passivation pipeline is connected with a storage tank and a water pump into a circulation passage. In the storage tank, sufficient purified water is injected and circulated by a water pump. After not less than 15 minutes, the branch pipe drain valve is opened and discharged while circulating.
Alkaline cleaning: NaOH is prepared into 2% NaOH solution with purified water. The main pipeline is immersed for 1 hour with a pump for not less than 45 minutes.
Rinse i Add purified water to the tank to start the pump, open the drain valve, and discharge while flushing. The discharge time is not less than 30 minutes until the conductivity of each outlet is consistent with the conductivity of the water in the tank.
Passivation with 20% nitric acid solution, pumping the main pipeline for not less than 60min pipe for 2h and then discharge.
The conductivity of the water rinse again with purified water is the same as the conductivity of the water in the tank.
4.2 Operation confirmation The equipment operation of the compressed air system and the compressed air after the system operation shall comply with the production requirements. Confirm that the device is ready for performance testing.
4.2.1 Air compressor operating condition evaluation standard Normal starting operation without abnormal noise.
4.2.2 The automatic unloading system of the air compressor is in the automatic running state, the time of filling the gas storage tank (3m3) is 矣1min; the valve □ to the use point is closed, and the equipment is turned on and the gas is in the running state of the load. The equipment is uninstalled and stopped.
4.2.3 Evaluation of freeze-drying operation The standard operation is stable without abnormal noise.
4.2.4 Valve â–¡ and delivery pipe evaluation standard valve â–¡ normal opening and closing, no leakage of the pipeline.
4.2.5 Gas supply evaluation criteria for each gas point The gas supply for each gas point should be normal.
4.2.6 Air filter 芫 检测 使用 使用 使用 使用 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气 空气At full load operation, the air quality check at each point of use is verified to confirm whether the performance indicators of water, oil, cleanliness and microorganisms during the normal operation of the compressed air system can meet the design requirements.
The qualification criteria for the confirmation of compressed air performance are shown in Table 2.
4.3.1 Moisture detection Using the Dräger compressed air quality detector, open the compressed air pipeline valve, connect the pressure reducing valve to the air outlet, adjust the pressure reducing valve knob to maintain the pressure at about 0.3MPa; lock the pressure reducing valve, connect the compression The air quality detector opens the two ends of the Dräger water test tube with the opener and inserts the test tube holder and starts to count the ice detection tube for 10 minutes. The moisture content in the compressed air should be less than 100mg/m3, then the moisture test is qualified. .
4.3.2 After the oil detector is removed for 1125s, the oil pipe is broken at the indication point so that the liquid in the ampoule flows through the indicator layer for about 10mm. After waiting for 1min, the oil content in the compressed air should be less than 0.1mg/m3. If there is no color change, the oil content is tested. If the color of the ampoule is changed to color, the oil detection is unqualified.
4.3.3 Checking the number of dust particles In the compressed air use point, use the valve to properly reduce the pressure. Use the dust particle detector to set the measurement period to 60s and the interval between 60s. The probe of the detector is placed on the cleaner for 23 minutes. The test and reading are directly performed by aligning the air outlet of the compressed air.
4.3.4 Detection of planktonic bacteria Table 2 Compressed air performance confirmation Eligibility standard table Test item Qualified standard water content 100mg/m3 Oil content 0.1mg/m3 Dust particles A-level area B-level area C-level area D-class area particle concentration > 0.5m Particle particle concentration > 5.0 m particle particle concentration > 0.5 m particle particle concentration > 5.0 m particle particle concentration > 0.5 m particle particle concentration > 5.0 m particle particle concentration > 0.5 m particle particle concentration > 20000 / M3 microorganism (floating bacteria) Class A area B level area C level area D level area <1CFU/m3矣 Connect the compressed air of each gas point to the pressure regulating valve, set the pressure to 0.1MPa, empty row for 5min; compress The air is passed into the stainless steel isolation device, and the stainless steel isolation device is placed on the floating air dust sampler to open the floating air dust sampler with a sampling amount of 1 m3. After the sample is taken with the gas point, the culture dish is placed in 3035 C for 3 days. To observe the growth of microorganisms.
4.3.5 Checking the sediments Refer to the test method for the settled bacteria in the clean room (area) of the pharmaceutical industry (GB/T162942010). 4, disinfection with 70% ethanol 23 times near the test site to ensure that the test environment clean testers are 2, in compression The air use point is sterilized by a UV lamp for 1 hour, and the plastic bag is placed in the air outlet. Under the plastic bag, a petri dish containing nutrient agar medium is placed. 2 thorns are used to adjust the compressed air pressure to 0.3 MPa. The culture medium was statically tested for 30 min, and cultured at 7 C for 5 days at a constant temperature for colony counting.
5 Conclusion As a special product, the drug is closely related to people's life and health. Therefore, the State Food and Drug Administration has established strict quality standards for the pharmaceutical industry. Among them, compressed air is a key medium in the pharmaceutical industry. The compressed air piping system must be inspected regularly. The compressed air filter and the breathing filter are tested for oil smelting, oil vapor, moisture and microorganisms mixed in compressed air. Test to ensure that the compressed air quality meets GMP requirements. 7 IS0B57312001 Compressed air Part 1 Contaminant and cleanliness grade CB/T132771S91 - General compressed air quality grade CB500292003 Compressed air station design specification CB/T162942010 Pharmaceutical industry clean room (zone) test method for sounding bacteria.
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