GMP requirements for tablet press production equipment

1、 The design requirements of tablet production equipment 1) equipment selection 1) close to and exceed the international advanced level, or have obvious technical advantages compared with the same type of domestic products 2) It has the functions of dust collection and cleaning 3) The operation is convenient and reliable, and there is necessary adjustment device Such as mechanical adjustment device, filling adjustment device, pressure adjustment device, speed adjustment device, sheet thickness adjustment device, etc 4) It has reliable safety protection function Such as pressure overload protection function, current overload protection function Some equipment with high degree of automatic control also has the functions of breaking and protecting, scraping out, fault alarming, automatic weighing and testing, etc 5) The design of the tablet pressing chamber shall meet the requirements of airtight (isolated from the outside), no pollution, no dead angle, easy to observe, easy to clean, easy to assemble and disassemble the mould, etc 6) It has a protective device to prevent injury to human body Such as grounding device, over-current breaking protection device, automatic opening breaking protection device, etc 7) The design is beautiful and simple, easy to operate, observe and maintain 2 Determination of performance parameters 1) in line with national or industrial standards Formulate enterprise product standards that are stricter than national or industrial standards, and actively promote the adoption of international standards, such as EU standards and IPT standards for tablet dies 2) Good sealing and isolation measures For example, the sealing and isolation between the mechanical components and the tablet pressing chamber, the sealing and isolation between the punch body (the up and down movement guiding role) and the punch top (the part contacting with the material), the sealing and isolation between the upper and lower parts of the turntable (the punch body guiding role) and the middle worktable (the area of material flow and tablet forming), the sealing and isolation between the tablet pressing chamber and the outside, etc 3) Good mechanical properties The transmission is stable, with appropriate accuracy, low noise, no obvious vibration and abnormal thermal deformation 4) Select appropriate raw materials, standard parts and accessories According to different functions and uses of mechanism components, raw materials, standard parts and accessories are selected economically and reasonably The selection of raw materials, standard parts and supporting parts in contact with the materials shall meet the requirements that will not affect the properties, purity and quality of the drugs, such as the selection of austenitic stainless steel materials; the selection of non-toxic non-metallic materials; coating on the surface of some carbon steel or cast iron parts (the coating materials must meet the GMP requirements and are not easy to be peeled off) 3 Technical document management 1) there is a complete set of technical documents and quality records that meet the national standards, the actual situation of the enterprise, and the requirements of equipment manufacturing, installation and operation a) In the equipment selection stage: there are documents and records such as information collection, market research, technical investigation, feasibility analysis, development decision-making, etc b) In the stage of equipment design: there are documents and records such as product design scheme, technical and economic cost analysis, design calculation, design verification, structure and component design, process design, etc 2) Establish document control files, standardize management, and ensure the operation quality and traceability of the design system 2、 Manufacturing requirements for tablet pressing production equipment 1 Purchasing 1) establish purchasing quality control files, select qualified and reputable suppliers, and ensure purchasing quality 2) According to the requirements of the procurement documents, purchase the raw materials and all kinds of materials that meet the quality requirements and have the quality assurance certificate or qualification certificate 3) Carry out necessary material chemical analysis for main key parts and raw materials with GMP requirements 4) Carry out incoming inspection and quality tracking for important standard parts and accessories 2 Manufacturing 1) manufacture, assemble and commission parts according to design drawings, process documents and relevant standards 2) Set up processing quality control points for the manufacturing of main key parts and standardize the construction 3) Strengthen the quality inspection of parts manufacturing with GMP requirements to prevent mixing and knocking 4) Necessary quality control is carried out for the surface coating process of some parts required by GMP to prevent coating peeling and rusting 3 Inspection 1) inspect the manufacturing, assembly and commissioning of parts and components according to the design drawings, process documents and relevant standards 2) Establish incoming inspection, process inspection and Zui final inspection system 3) Formulate inspection procedures for product performance and main key parts 4) Establish product quality control files, record, check, track and feedback product quality 3、 The installation requirements of tablet production equipment (tablet press) 1 The manufacturer shall formulate the operation manual of the equipment, including: composition and use of the machine; technical parameters; transportation, installation, storage; operation and adjustment; maintenance; catalog of vulnerable parts, and has the obligation to help and guide the user to install and use the equipment 2 The user shall install the equipment according to the installation method and requirements in the operation manual 3 The installation environment of the equipment shall meet the relevant provisions of the pharmaceutical production quality management code (1998 Revision) 4 Necessary auxiliary facilities shall be provided, such as power supply, compressed air source, feeding device, dust removal device, etc 5 The equipment shall be subject to air operation or test run to confirm the stability and adjustability of each mechanism function of the equipment, and the reliability and safety of the instrument 6 The manufacturer and the user confirm the pharmaceutical production process, so that the equipment can meet the conditions of pharmaceutical production process, and reach the Zui good state 4、 The performance requirements of tablet production equipment (tablet press) 1 Select one or several physical test parameters, such as the shape, size and thickness of the pressed tablet, determine the appropriate speed for physical production, and the quality of the pressed tablet meets the requirements of the finished product and national standards 2 The equipment conforms to the design parameters in the simulated production operation or the physical production operation, and there is no abnormal leakage of powder, liquid or metal chips and particles in the tablet pressing room 3 The operation and maintenance are simple, safe and reasonable, and the disassembly and assembly of mould, feeder and other parts are convenient 4 The equipment is easy to clean without dead angle and leakage