Discussion on preparation machinery and GMP requirements from the practice of pharmaceutical factory

GMP has been implemented for nearly 20 years since 1982 In this period of time, due to the repeated propaganda of GMP by the superior competent department and the repeated comparison of the gap between the traditional production mode and GMP, the awareness of GMP implementation of pharmaceutical plants has been improved, from unconscious implementation to conscious implementation At present, most of the pharmaceutical factories in China have a gratifying situation Most of them are actively preparing and creating conditions for their enterprises to obtain GMP certificates as soon as possible However, it is a difficult system engineering to obtain GMP certificate, which requires hardware facilities, including modern fully closed constant temperature and humidity plant, as well as software system, including various management systems and operation specifications In addition, in daily operation, we should consciously abide by the technical requirements of the above hardware and software, and all operation data should be input into the computer GMP specification is very detailed for the content of pharmaceutical factory, but for the pharmaceutical equipment used in pharmaceutical factory, it is only a macro discussion, which does not and is impossible to make a detailed description for each machine one by one, which increases the difficulty for pharmaceutical factory to select GMP compliant machines Because of this, we need the users of pharmaceutical factories and manufacturers of pharmaceutical machinery factories to discuss together under the GMP standard, and get a consensus The key to the requirements of GMP for preparation equipment is: (1) the surface of the equipment is clean and easy to clean, the equipment with materials should be sealed as much as possible, and the inner wall in direct contact with the materials should be smooth, flat and avoid dead angle Low carbon stainless steel shall be selected for aseptic pharmaceutical equipment and containers; (2) transmission parts of the equipment shall be well sealed to prevent the leakage of lubricating oil from polluting the drugs, containers and materials; (3) equipment with large amount of dust in the production process of the preparation shall be equipped with dust-proof, dust catching and dust suction devices The discharged gas shall be filtered to prevent air from pouring back; (4) the dry air, compressed air and inert gas for workshop production shall be equipped with purification device; (5) the packaging machinery shall be easy to operate without error, and shall have functional display; (6) Matched parts: such as lighting, valves, electrical switches, frequency converters, worktables, etc shall be of high quality and durable products to prevent maintenance personnel from frequent access to production workshops and ceiling areas due to quality failure According to the above basic principles and the author's practice in pharmaceutical factories for many years, this paper discusses the existing pharmaceutical production equipment for reference to manufacturers and users 1 Solid preparation production equipment 1 Pulverizer: there are many pulverizers in the market at present, including hammer pulverizer, water jacketed hob pulverizer and air flow pulverizer Among them, Zui, a 30b pulverizer, is a typical one Its working principle: materials in the high-speed operation of the closed studio, due to the centrifugal force, directly shear, friction, impact, the material is crushed, until the process required number of mesh, but 30b crusher in the "model, structure" and pharmaceutical production requirements, there is a certain distance Because this model has been an old model for nearly half a century, no improvement has been made Now it should be changed to adapt to the requirements of the new situation and facilitate operation The comparison is as follows: the operator of 30b crusher pharmaceutical factory reacts to the shape: the vertical motor is cleaned under the fuselage every day, inconvenient and incomplete, the motor is susceptible to moisture and insecurity under the fuselage, so the horizontal frame material should be changed: the angle iron is easy to rust, and the discharging position does not meet the requirements: the discharging port is in the front of the fuselage, and the position close to the discharging port of the operator should be moved to the machine At the bottom, it is easy to operate the fuselage: the full seal should be open for cleaning According to the requirements and specifications of the users of the pharmaceutical factory, it is suggested to improve the 30b model as follows ① Shape: from the original vertical type to the horizontal type, the length of the fuselage is longer, the motor moves from the fuselage down to the fuselage, and is connected with a belt to make a cover ② Frame material: angle iron shall be replaced by stainless steel square frame ③ Discharge port: the front of the machine body shall be moved to the bottom of the machine body, away from the operator, so as to facilitate the operation ④ Body: not closed, easy to clean Fig 1 the machine after 30b pulverizer is changed to horizontal type is shown in Fig 2 Fig 2 (omitted) the improved horizontal pulverizer ensures its advantages: fast pulverizing speed and large quantity It is also in line with GMP requirements, easy to operate, clean, and has good safety performance This machine is cheap, good in quality and practical It is one of the main machines used in GMP transformation and crushing section of pharmaceutical factory 2 Water jacketed high-speed crusher: This machine imitates the UK, and its shape, transmission structure, hob grinding, screw feed design are very scientific Grinding principle of the machine: the bow top of the working room is a static blade, and there is a high-speed rotating dynamic blade The materials are cut and crushed by the high-speed rotating grinding blade in the working room to reach the fineness required by the user This machine is also one of the GMP machines of pharmaceutical factory However, it should be noted that when purchasing this machine, it is necessary to carefully check whether the screw, hob, water jacket and bow top of the working room are smooth and polished everywhere If there is dead angle, it is easy to produce mixed drugs in production, which will bring loss to drug production In addition, when imitating this kind of equipment, the manufacturer must strictly control the processing, welding, polishing and other links, and strive to achieve the same brightness inside and outside The defect of this machine is: when the machine is running, it needs to use tap water to cool the high temperature The pipe diameter of tap water is 3 / 4 " The cooling water is directly discharged into the sewer, which wastes a lot of water If this machine is selected, the cooling water can be recycled 3 Airflow pulverizer: generally, airflow pulverizer is not suitable for preparation workshop The air flow pulverizer has a fineness of 1200 meshes, which is widely used in cosmetics industry and chemical industry At present, there are not many domestic manufacturers that can really produce up to the standard, mainly relying on imports 2 There are two types of vibrating screen: one is the hanging orchid type vibrating screen, the other is the circular plate type vibrating screen The hanging orchid vibrating screen is a traditional type, which has been used for decades Because of its simple structure, practicality and low cost, it is generally welcomed by pharmaceutical factories With the in-depth implementation and understanding of GMP specifications, the hanging orchid vibrating screen has been replaced by the circular plate vibrating screen, because the hanging orchid vibrating screen does not meet the requirements of the specifications: ① The motor is exposed on the top, so it is difficult to clean and unsafe; ② the screen is made of bamboo pieces, which have adsorption effect, and the bamboo pieces have gaps, so it is not suitable to clean; ③ the bamboo mesh frame is easy to break, and the renewal cycle is short; ④ the whole screening process is not carried out in a closed container, but open type, with serious dust flying, endangering the health of operators and increasing the burden of air conditioning system Therefore, the hanging orchid type oscillating screen is not suitable for use in GMP plant, instead of the circular plate oscillating screen As a foreign model, the disc oscillating screen appeared in the domestic market as early as the early 1980s, and began to be recognized and accepted by users after the 1990s Now many pharmaceutical factories are using this equipment At present, there are more than a dozen disc shaker manufacturers in the production park It is difficult to say whether the manufacturing quality meets the specifications It should be said that there are not many units that really meet the quality standards, and most of them produce it The internal quality of this equipment is worrisome, especially the welding parts of the feed port and discharge port in the screen are not polished and polished Once used, it is not easy to thoroughly clean, and it is easy to produce chemical mixture Because of its small size, it is movable and easy to operate Oscillating materials are sieved, classified and graded in airtight containers, which do not produce dust It is very popular with users, and it is one of the indispensable machines in the screen powder room To sum up, when purchasing equipment, users must consider from all aspects, inspect the appearance, and pay more attention to whether the internal quality really conforms to GMP specifications The second is the price In addition, the engineering and technical personnel of the factory should study the GMP specification requirements, understand the actual use requirements of the pharmaceutical factory, design and manufacture machines, and better serve the pharmaceutical factory.