Clean workshop equipment trial operation and debugging


Before the test run of the supporting water pump in the clean workshop, check whether the components of the water pump and the auxiliary system are fully installed. The bolt connection parts of the water pump should not be loosened. The impeller should be light, flexible and normal to move the impeller by hand, and there should be no abnormal phenomena such as jamming; With the valve opening and closing of the auxiliary pipeline system...
Text label: clean workshop equipment, commissioning and debugging, Zhongjing Global Purification

Test run and commissioning of clean workshop equipment


Before the test run of the supporting water pump in the clean pharmaceutical cleanroom, check whether the components of the water pump and the auxiliary system are fully installed. The bolt connection parts of the water pump should not be loosened. The impeller should be light, flexible and normal to move the impeller by hand, and there should be no abnormal phenomena such as jamming; The valve opening and closing status of the auxiliary pipeline system should meet the design requirements after inspection and adjustment. Before operation, the inlet valve should be fully opened and the outlet valve should be fully closed. After the pump is started, the outlet valve should be opened again. The clamp-type ammeter measures the starting current of the motor, and then measures the running current of the motor after the water pump is running normally to ensure that the running power or current of the motor does not exceed the rated range; after continuous operation for 2 hours, when the rolling bearing is running, the maximum temperature of the bearing should be less than 75 ℃ , If a sliding bearing is used, the maximum temperature of the bearing should be less than 70 ℃; after the pump is checked to be normal, it can be continuously operated for many 2H. If no problem is found during operation, the test run of the pump is qualified, and the test run report is filled in The content is the same as that of the fan; after the trial operation, the inlet and outlet valves of the pump and the valves of the auxiliary piping system should be closed. In the case of non-continuous operation, in order to prevent corrosion and freeze cracking, the water accumulated in the pump should be drained.


The main reasons that cause the outlet of the pump to display pressure, but the water pipe does not flow is: the resistance of the outlet pipe is too large or the pipe is blocked; the impeller of the pump is blocked; the rotation direction of the motor is reversed; the number of revolutions of the pump is not enough. The main reasons for the abnormal sound of the pump and the failure of the pump to fill the water are: the water absorption height is too high; the temperature of the water pumped by the pump is too high; there is air infiltration at the water absorption place. Reasons for the excessive power consumption of the pump: the packing gland is too tight, and the stuffing box is heated; the pipeline resistance is smaller than the design, and the pump flow is too large; the impeller and the sealing ring are worn. The main reasons for bearing heating are: the water pump bearing has no lubricating oil or too much lubricating oil; the shafts of the water pump and the motor are not concentric. The main reasons for the vibration of the water pump are: the shafts of the water pump and the motor are not concentric; the foot bolts are loose. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean workshops and purification workshops.














Before the trial operation of the cooling tower, the inclusions and dirt in the tower should be cleaned to prevent the blockage of the cooling water pipe or condenser; the cooling tower and the cooling water pipeline system should be flushed with water, and the pipeline system should be free of water seepage. Check the automatic water supply valve Whether the action state is flexible and accurate, the water level of the make-up water and overflow water in the cooling tower should be checked; when the cooling tower is in trial operation, the operation state of the fan and the working state of the cooling water circulation system should be checked, and the running situation and related data should be recorded. , If there is no abnormal phenomenon, the continuous operation time should not be less than 2H; measure the motor starting current and running current of the fan, and make the running current within the rated current range; check whether the water spray and water absorption are balanced, and the water supply The operating conditions such as the water level of the water collection tank and the water level of the water collection tank should be in a good state that the cooling water does not run and leak; if the cooling tower is not used for a long time after the trial operation, in order to prevent the equipment from freezing, all the water in the circulation pipeline and water collection tank should be released.
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Acceptance requirements for air supply and exhaust and dust removal systems in clean workshops

The installation of various air duct components and operating mechanisms should be able to ensure their normal use and easy operation; for the installation of the oblique plate air valve, the valve plate must be pulled upwards. It should be in the direction of airflow; check valve, automatic exhaust valve...
Text label: air supply and exhaust system for clean room, acceptance of clean room, dust removal system for clean room

Acceptance requirements for air supply and exhaust and dust removal system in clean room


The installation of various air duct components and operating mechanisms should be able to ensure their normal use and easy operation; for the installation of the oblique plate air valve, the valve plate must be pulled upwards. It should be in the direction of the airflow; the installation direction of the check valve and the automatic exhaust valve should be correct; the tightness inspection of the air duct of the low-pressure system should adopt random inspection, and the sampling inspection rate should be 5%, and there should be no less than 1 system. On the premise of the guarantee, the light leakage method is used for detection. If the test fails, the air leakage test shall be carried out according to the specified sampling rate; for the tightness inspection of the air duct of the medium pressure system, after the light leakage method is qualified, the system air leakage test shall be sampled. , the sampling rate is 20%, and there should be no less than 1 system; the tightness inspection of the high-voltage system air ducts is to carry out the air leakage test for all of them; the sampling systems that are inspected for the tightness of the system air ducts should be all qualified and deemed to have passed. If there is any unqualified, the sampling inspection shall be doubled until all of them are qualified.


For manual airtight valve installation, the direction of the arrow marked on the valve must be consistent with the direction of the shock wave; before the installation of the air duct, the internal and external debris should be removed, and cleaning and protection work should be done well; the installation position, elevation and direction of the air duct should be In line with the design requirements, the configuration of the on-site air duct interface shall not reduce its effective section; the bolts connecting the flanges should be tightened evenly, and the nuts should be on the same side; the connection of the air duct interface should be tight and firm, and the gaskets of the air duct flange The material should meet the requirements of the system function, the thickness should not be less than 3mm, the gasket should not protrude into the pipe, nor should it protrude out of the flange; the installation of the flexible short pipe should be tight and moist, without obvious distortion; stretchable metal or non-metallic The length of the flexible air duct should not exceed 2m, and should not be bent or slumped; the contact between the stainless steel plate and aluminum plate air duct and the carbon steel bracket should be isolated or anti-corrosion insulation measures. The connection of the installation air duct without the flanged air duct should be complete and free of defects, the surface should be flat, and there should be no obvious distortion; the surrounding gaps of the socket-type air duct should be consistent, without obvious bending or folds, and the sealant applied inside should be complete , The outer adhesive sealing tape should be firmly pasted, complete and free of defects; the connection of the air duct in the form of a thin steel plate flange
, the interval between elastic inserts, spring clips or fastening bolts should not be greater than 150mm, and the distribution should be uniform without loosening; the rectangular air duct connected by the inserts should be flat and without obvious bending. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for dust-free workshops and purification workshops.














The air duct, static pressure box and other components must be wiped clean to avoid oil pollution and floating. When the construction is stopped or completed, the port should be sealed; the flange gasket should be dust-free, not easy to age and have A certain strength and elasticity material, the thickness is 5-8mm, latex sponge shall not be used, the flange gasket shall be spliced u200bu200bas little as possible, and straight seam butt connection shall not be allowed, and it is strictly forbidden to apply paint on the surface of the pad; air duct and dust-free pharmaceutical cleanroom ceiling, The joints of maintenance structures such as partition walls should be tight; the radius of curvature of the vacuum system elbow should not be less than 4 times the pipe diameter, the inner wall surface of the elbow should be smooth, and no corrugated elbow should be used; The included angle should not be greater than 45°, and two inclined tees should be used for the production of the four-way; the air outlet should be cleaned before installation, and the joint between the frame and the building ceiling or wall should be added with gasket or sealant. There should be air leakage; the air supply outlet with high-efficiency filter should adopt a boom whose height can be adjusted separately.
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The 100,000-level purification workshop has strict requirements for purification, and there are also some related detection methods. Next, Dongguan Keshilai Xiaobian will tell you how to check whether the 100,000-level purification workshop meets the standard. Under normal circumstances, the detection method of sedimentation bacteria is mainly used to detect whether the 100,000-level purification pharmaceutical cleanroom meets the standard, and the specific methods are as follows: When opening the sterile operating table, several sterile petri dishes with an inner diameter of 90 mm need to be poured into the nutrient agar medium that has been melted and cooled to 45 °C, and then placed upside down in an incubator at 30~35 °C for 48 hours to prove sterile backup. use. Place the petri dish covered with nutrient agar medium in the designated area, about 1 meter from the ground, expose it to the air for 30 minutes to collect the settled bacteria, then cover the plate and let it stand in the incubator at 30-35 °C for 48 hours , take out and count. At this time, attention should be paid to the operating state in the 100,000-level purification workshop. Detect the number of settled bacteria, no more than 10 per plate, and prove that it has reached the standard of 100,000-level purification workshop. The sedimentation bacteria method can generally be monitored once a month. Each test should pay attention to data records and test process records. Previous: Matters needing attention when using purification workshop Next: Three design requirements that must be known in a 100,000-level purification pharmaceutical cleanroom
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Two-color tablet press is to grind two different materials into one tablet. The two materials are separated from each other and have different colors. The shrinkage of the two-color tablet is mainly based on the design and modification of the lower slide rail. 2 fillings and a slice. The key situation in the process of suppressing two-color tablets by the two-color tablet press is: (1) The content of the two materials on the same tablet does not meet the requirements. This is mainly because the filling adjustment system is not adjusted, and the content of one material can be adjusted first. Then adjust the content of the other material; (2) The two materials of the extruded tablet have a split state, and the strength is uneven. One material is harder and the other is softer. The main reasons are: 1) the material Reasons, density, drying humidity, poor adjustment of the uniformity of the two materials, and then adjust the materials before suppression; 2) Improper adjustment of the pressure of the two materials. The principle of producing a two-color film is the second filling, once, if the pressure is not adjusted after the first filling, the strength of the second half will become hard or loose. After the second fill, the pressure is set for the complete tablet, so the pressure adjustment determines the level of tablet formation and fusion. Two-color tablet presses usually need to be equipped with 2 vacuum cleaners, which can separate the two materials for powder absorption and recovery. Provided the user specifies the composition of the two materials, the tablet press can be equipped to remove tablets from each of the materials and measure them to determine their content

Pharmacies play a critical role in healthcare, ensuring that patients receive the medications they need to manage their conditions effectively. To maintain the quality and efficacy of these medications, pharmacies must implement stringent measures to ensure a sterile and controlled environment. One such measure gaining prominence in the pharmaceutical industry is the use of laminar flow clean rooms. These highly controlled spaces provide an ideal environment for compounding medications, minimizing the risk of contamination and ensuring precision control. In this article, we will explore the benefits and implementation of laminar flow clean rooms in pharmacies, revolutionizing the way medications are prepared and dispensed.

The Importance of Sterility in Pharmacies

Pharmacies are responsible for compounding medications that meet the specific needs of individual patients. Any compromise in the sterility of these preparations can have severe consequences on patient health. Contaminated medications can lead to infections, allergic reactions, or even treatment failure. Therefore, it is essential that pharmacies adhere to strict cleanliness protocols and invest in cutting-edge technologies to prevent any compromise in the sterility of the medications they dispense.

The Role of Laminar Flow Clean Rooms

Laminar flow clean rooms are specially designed spaces that provide a controlled environment for compounding medications. These rooms are equipped with High-Efficiency Particulate Air (HEPA) filters that remove particles and microorganisms from the air, ensuring a sterile atmosphere. The air in a laminar flow clean room moves in a unidirectional flow, passing over the compounding area to prevent any potential contamination from entering the workspace.

Implementing Laminar Flow Clean Rooms in Pharmacies

Implementing laminar flow clean rooms in pharmacies requires careful planning and consideration. Here are the essential steps involved in setting up a laminar flow clean room:

1. Facility Assessment and Design

Before implementing a laminar flow clean room, it is crucial to assess the facility and determine the optimal location for the clean room. Factors such as available space, HVAC system capacity, and proximity to other critical areas should be taken into account. Once the assessment is complete, a detailed design plan can be developed, considering the workflow, equipment placement, and necessary utilities.

2. Selecting the Right

Choosing the appropriate equipment is crucial to ensure the effectiveness of the laminar flow clean room. HEPA filters, the backbone of these clean rooms, must meet industry standards and provide the required level of filtration efficiency. Additionally, clean benches, biological safety cabinets, and laminar flow hoods are essential components that aid in maintaining sterility during compounding operations.

3. Installation and Validation

Once the pharma machinery is selected, installation should be carried out by experienced professionals to ensure proper functionality and compliance with regulatory requirements. After installation, a thorough validation process must be conducted to verify that the clean room meets the defined specifications. This process typically includes testing the airflow velocity, air changes per hour, and particulate counts to ensure optimal performance.

4. Standard Operating Procedures (SOPs) Development

To maintain the sterility and effectiveness of the laminar flow clean room, it is essential to develop comprehensive Standard Operating Procedures (SOPs). These SOPs outline the specific protocols and guidelines for personnel working in the clean room, including gowning procedures, cleaning techniques, and aseptic compounding practices. Regular training and adherence to these SOPs are crucial to ensure consistent compliance and minimize the risk of contamination.

5. Ongoing Monitoring and Maintenance

Once the laminar flow clean room is operational, ongoing monitoring and maintenance are crucial to ensure its continued effectiveness. Routine particle counts, air velocity measurements, and regular HEPA filter replacements are necessary to maintain the desired sterility levels. Furthermore, periodic re-validation of the clean room should be conducted to ensure compliance with regulatory standards and identify any necessary updates or improvements.

In Summary

The implementation of laminar flow clean rooms in pharmacies has revolutionized the way medications are prepared and dispensed. By providing a highly controlled and sterile environment, these clean rooms minimize the risk of contamination and ensure precision control during compounding operations. The steps involved in implementing laminar flow clean rooms, including facility assessment and design, pharma machinery selection, installation and validation, SOP development, and ongoing monitoring and maintenance, are critical to ensure the success and effectiveness of these controlled environments. By investing in technologies that prioritize patient safety and product quality, pharmacies can continue to play a vital role in delivering optimal healthcare outcomes.

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