The GMP for pharmaceutical production quality management, which has been in operation since 1982, has been going through nearly 20 years. During this period, due to the repeated promotion of GMP regulations by the superior authorities, the gap between the traditional production mode and the GMP standard was repeatedly compared, which enabled the pharmaceutical companies to improve their implementation of GMP, from unconscious execution to conscious implementation. Nowadays, most pharmaceutical companies in the country have a gratifying situation. Most of them are actively preparing and creating conditions for their enterprises to get GMP certificates as soon as possible. But taking the GMP certificate is a difficult system project, which requires hardware facilities, including a modern, fully enclosed constant temperature and humidity plant, and a software system that includes various management systems and operating specifications. Moreover, in daily operation, we must consciously abide by the technical requirements of the above hardware and software, and all operational data must be input into the computer. The GMP regulations are very detailed in the content of the pharmaceutical factory, but the preparation equipment used by the pharmaceutical company is only a macro discussion. It is not possible or impossible to explain each machine one by one, which increases the choice of the pharmaceutical factory. The difficulty of the GMP machine. Because of this, we need the users of our pharmaceutical companies and the manufacturers of pharmaceutical factories to discuss and agree on the GMP regulations.
The GMP specification requires the preparation equipment. The key is: (1) The surface of the equipment is clean and easy to clean. The equipment containing the materials should be sealed as much as possible. The inner wall in direct contact with the medicine should be smooth, flat and avoid dead corners. For the production of sterile pharmaceutical equipment and containers, low-carbon stainless steel should be used; (2) The transmission parts of the equipment should be well sealed to prevent the leakage of lubricating oil to cause pollution to drugs, containers and materials; (3) The amount of dust generated during the production of the preparation will be large. Equipment should be strengthened with dust and dust collection and dust collection devices. The exhaust gas should be filtered to prevent air from being poured; (4) There should be a purification device for the production of dry air, compressed air and inert gas in the workshop; (5) The packaging machinery should be simple to operate, without error, and have a functional display; (6) Equipped with supporting components: such as lighting, valves, electrical switches, inverters, worktables, etc., must use quality and durable products to prevent maintenance personnel from entering and exiting the production workshop and ceiling area frequently due to quality failures.
In light of the above basic principles and the practice of the pharmaceutical industry for many years, the relevant preparation production equipment will be discussed for the reference of the manufacturer and the manufacturer.
First, solid preparation equipment 1, pulverizer: the current market pulverizer, a lot of models, zui common hammer mill, water jacketed hob pulverizer, airflow pulverizer, which 30B pulverizer Zui typical. The working principle: the material is in the closed working chamber at high speed. Due to the centrifugal force, shearing, friction and impact occur directly, and the material is crushed until the number of meshes required by the process, but the 30B pulverizer is in “model and structureâ€. There is a certain distance from the production requirements of the pharmaceutical factory. Because this model has been an old face for nearly half a century, no improvement has been made. It should be improved to adapt to the requirements of the new situation and facilitate operation. The comparison is as follows: 30B pulverizer pharmaceutical operator response shape: vertical motor is cleaned daily under the fuselage, inconvenient, not thorough, the motor is vulnerable to moisture under the bottom, insecure, should be changed horizontal frame material: corner Iron easy to rust, does not meet the requirements of the discharge position: the discharge port is directly in front of the fuselage, close to the operator's discharge port position should be moved under the machine, easy to operate the fuselage: fully enclosed should be open, easy to clean
According to the requirements and specifications of the users of the pharmaceutical company, it is recommended to make the 30B type as follows. 1 Shape: From the original upright to horizontal, the length of the fuselage is lengthened, the motor is moved from the fuselage to the top of the fuselage, connected with a belt to make a cover. 2 Frame material: Angle iron should be changed to stainless steel square steel frame. 3 Discharge port: The front of the fuselage should be moved to the center of the fuselage, away from the operator, easy to operate. 4 Body: Not closed, easy to clean. Fig. 1 shows the machine after the 30B pulverizer 30B pulverizer is changed to the horizontal model. Figure 2 (omitted) The improved horizontal pulverizer guarantees its advantages: high pulverization speed and large amount. It also meets the requirements of GMP, and is easy to operate, clean and has good safety performance. This machine is cheap and practical, and has strong practicability. It is one of the main machines used in the GMP transformation of the pharmaceutical factory.
2, water jacket high-speed pulverizer: This machine is imitation of the United Kingdom, its shape, transmission structure, hob smash, screw feed design are very scientific. The principle of the machine smashing: the top of the studio is a stationary knife edge, and the dynamic knife edge rotates at a high speed. The material is in the working chamber, and the pulverizing knife that is rotated at a high speed shears and smashes to achieve the fineness required by the user. This machine is also one of the preferred machines of GMP, but it should be noted that when purchasing this machine, it is necessary to carefully check whether the screw, the hob, the water jacket and the top of the studio are smooth and polished everywhere. If there is a dead angle, it is easy to produce mixed drugs in production, which will bring losses to the production of drugs. In addition, when manufacturing such equipment, the manufacturer must strictly control the processing, welding, polishing, etc., and strive to be as bright as inside and outside. The defect of this model is: when the machine is running, the high temperature is to be cooled by tap water. The tap water pipe diameter is 3/4", the cooling water is directly discharged into the sewer, and the water source is wasted more. If this machine is used, the cooling water will be recycled. .
3, air flow powder machine: air flow pulverizer is generally not suitable for use in the preparation workshop. The jet mill has a crushing fineness of 1200 mesh and is widely used in the cosmetics industry and the chemical industry. At present, there are not many manufacturers that can truly meet the standards in China, mainly relying on imports.
Second, there are two kinds of oscillating sieves: one is a hanging blue type oscillating screen, and the other is a disc type oscillating screen.
The hanging blue vibrating screen is a traditional type. It has been used for decades. Because the structure of the hanging blue vibrating screen is simple, practical and cost-effective, it is generally welcomed by the pharmaceutical industry. With the deep implementation and understanding of the GMP standard, the hanging blue vibrating screen It has been replaced by a disc-type oscillating screen, because the following factors do not meet the requirements of the specification: 1 The motor is exposed on the top, which is difficult to clean and unsafe; 2 The screen is made of bamboo and has adsorption. Function, bamboo has a gap, should not be cleaned; 3 Bamboo net frame is easy to break, the renewal cycle is short; 4 The whole sieving process is not carried out in a closed container, but open, dust flying is serious, endangering the health of operators Increase the burden on the air conditioning system. Therefore, the hanging blue type oscillating screen should not be used in the GMP workshop, instead of the disc oscillating screen.
The disc-type oscillating screen is a foreign-like model. It began to appear in the domestic market as early as the early 1980s. After the 1990s, it was accepted and accepted by users. Now many pharmaceutical companies are using this equipment. There are more than a dozen manufacturers of disc-type vibrating screens. The manufacturing quality is in line with the specifications. It is difficult to say that it should be said that there are not many real quality standards, and most of them produce this equipment. The internal quality is worrying, especially the feeding port and the outlet of the screen are not polished or polished. Once used, it is not easy to clean thoroughly, and it is easy to produce mixed drugs. The disc oscillating screen is movable and easy to operate due to its small size. The oscillating material is sieved, classified and classified in a closed container, and does not generate dust. It is very popular among users and is one of the indispensable models among the sieve powder.
In summary, when purchasing equipment, users must consider all aspects, to examine the appearance, but also to pay attention to whether the internal quality is in line with GMP regulations. Followed by the price. In addition, the engineering and technical personnel of the production plant should thoroughly study the GMP requirements, understand the actual use requirements of the pharmaceutical factory, design and manufacture the machine, and better serve the pharmaceutical factory.
The GMP specification requires the preparation equipment. The key is: (1) The surface of the equipment is clean and easy to clean. The equipment containing the materials should be sealed as much as possible. The inner wall in direct contact with the medicine should be smooth, flat and avoid dead corners. For the production of sterile pharmaceutical equipment and containers, low-carbon stainless steel should be used; (2) The transmission parts of the equipment should be well sealed to prevent the leakage of lubricating oil to cause pollution to drugs, containers and materials; (3) The amount of dust generated during the production of the preparation will be large. Equipment should be strengthened with dust and dust collection and dust collection devices. The exhaust gas should be filtered to prevent air from being poured; (4) There should be a purification device for the production of dry air, compressed air and inert gas in the workshop; (5) The packaging machinery should be simple to operate, without error, and have a functional display; (6) Equipped with supporting components: such as lighting, valves, electrical switches, inverters, worktables, etc., must use quality and durable products to prevent maintenance personnel from entering and exiting the production workshop and ceiling area frequently due to quality failures.
In light of the above basic principles and the practice of the pharmaceutical industry for many years, the relevant preparation production equipment will be discussed for the reference of the manufacturer and the manufacturer.
First, solid preparation equipment 1, pulverizer: the current market pulverizer, a lot of models, zui common hammer mill, water jacketed hob pulverizer, airflow pulverizer, which 30B pulverizer Zui typical. The working principle: the material is in the closed working chamber at high speed. Due to the centrifugal force, shearing, friction and impact occur directly, and the material is crushed until the number of meshes required by the process, but the 30B pulverizer is in “model and structureâ€. There is a certain distance from the production requirements of the pharmaceutical factory. Because this model has been an old face for nearly half a century, no improvement has been made. It should be improved to adapt to the requirements of the new situation and facilitate operation. The comparison is as follows: 30B pulverizer pharmaceutical operator response shape: vertical motor is cleaned daily under the fuselage, inconvenient, not thorough, the motor is vulnerable to moisture under the bottom, insecure, should be changed horizontal frame material: corner Iron easy to rust, does not meet the requirements of the discharge position: the discharge port is directly in front of the fuselage, close to the operator's discharge port position should be moved under the machine, easy to operate the fuselage: fully enclosed should be open, easy to clean
According to the requirements and specifications of the users of the pharmaceutical company, it is recommended to make the 30B type as follows. 1 Shape: From the original upright to horizontal, the length of the fuselage is lengthened, the motor is moved from the fuselage to the top of the fuselage, connected with a belt to make a cover. 2 Frame material: Angle iron should be changed to stainless steel square steel frame. 3 Discharge port: The front of the fuselage should be moved to the center of the fuselage, away from the operator, easy to operate. 4 Body: Not closed, easy to clean. Fig. 1 shows the machine after the 30B pulverizer 30B pulverizer is changed to the horizontal model. Figure 2 (omitted) The improved horizontal pulverizer guarantees its advantages: high pulverization speed and large amount. It also meets the requirements of GMP, and is easy to operate, clean and has good safety performance. This machine is cheap and practical, and has strong practicability. It is one of the main machines used in the GMP transformation of the pharmaceutical factory.
2, water jacket high-speed pulverizer: This machine is imitation of the United Kingdom, its shape, transmission structure, hob smash, screw feed design are very scientific. The principle of the machine smashing: the top of the studio is a stationary knife edge, and the dynamic knife edge rotates at a high speed. The material is in the working chamber, and the pulverizing knife that is rotated at a high speed shears and smashes to achieve the fineness required by the user. This machine is also one of the preferred machines of GMP, but it should be noted that when purchasing this machine, it is necessary to carefully check whether the screw, the hob, the water jacket and the top of the studio are smooth and polished everywhere. If there is a dead angle, it is easy to produce mixed drugs in production, which will bring losses to the production of drugs. In addition, when manufacturing such equipment, the manufacturer must strictly control the processing, welding, polishing, etc., and strive to be as bright as inside and outside. The defect of this model is: when the machine is running, the high temperature is to be cooled by tap water. The tap water pipe diameter is 3/4", the cooling water is directly discharged into the sewer, and the water source is wasted more. If this machine is used, the cooling water will be recycled. .
3, air flow powder machine: air flow pulverizer is generally not suitable for use in the preparation workshop. The jet mill has a crushing fineness of 1200 mesh and is widely used in the cosmetics industry and the chemical industry. At present, there are not many manufacturers that can truly meet the standards in China, mainly relying on imports.
Second, there are two kinds of oscillating sieves: one is a hanging blue type oscillating screen, and the other is a disc type oscillating screen.
The hanging blue vibrating screen is a traditional type. It has been used for decades. Because the structure of the hanging blue vibrating screen is simple, practical and cost-effective, it is generally welcomed by the pharmaceutical industry. With the deep implementation and understanding of the GMP standard, the hanging blue vibrating screen It has been replaced by a disc-type oscillating screen, because the following factors do not meet the requirements of the specification: 1 The motor is exposed on the top, which is difficult to clean and unsafe; 2 The screen is made of bamboo and has adsorption. Function, bamboo has a gap, should not be cleaned; 3 Bamboo net frame is easy to break, the renewal cycle is short; 4 The whole sieving process is not carried out in a closed container, but open, dust flying is serious, endangering the health of operators Increase the burden on the air conditioning system. Therefore, the hanging blue type oscillating screen should not be used in the GMP workshop, instead of the disc oscillating screen.
The disc-type oscillating screen is a foreign-like model. It began to appear in the domestic market as early as the early 1980s. After the 1990s, it was accepted and accepted by users. Now many pharmaceutical companies are using this equipment. There are more than a dozen manufacturers of disc-type vibrating screens. The manufacturing quality is in line with the specifications. It is difficult to say that it should be said that there are not many real quality standards, and most of them produce this equipment. The internal quality is worrying, especially the feeding port and the outlet of the screen are not polished or polished. Once used, it is not easy to clean thoroughly, and it is easy to produce mixed drugs. The disc oscillating screen is movable and easy to operate due to its small size. The oscillating material is sieved, classified and classified in a closed container, and does not generate dust. It is very popular among users and is one of the indispensable models among the sieve powder.
In summary, when purchasing equipment, users must consider all aspects, to examine the appearance, but also to pay attention to whether the internal quality is in line with GMP regulations. Followed by the price. In addition, the engineering and technical personnel of the production plant should thoroughly study the GMP requirements, understand the actual use requirements of the pharmaceutical factory, design and manufacture the machine, and better serve the pharmaceutical factory.
1, supplementary poultry to all sorts of vitamins, amino acids, nutrient requirements, improve drug-application growth rate, effectively improve the quality of poultry. Improve the feed conversion rate.
2, enhance egg weight, improve the eggshell quality.
3, can increase rate, delay poultry , cattle and sheep reproductive function decline, extend the egg laying peak.
4, disease recovery use this product, can quickly recover the body function.
5, such as Chinese medicine astragalus extract to join, can stimulate the body produce interferon, interference viral replication, improving the body immunity.
6, ease because of vaccination, and turn group of the weather changes of the stress reaction.
Vitamins And Minerals,Mineral Premix,Mineral Supplement,Animal Mineral
Hebei Kexing Pharmaceutical Co., Ltd. , http://www.kexingpharma.com