1, master the concept and classification of pharmaceutical machinery and equipment, GMP certification and verification of the concept.
2, familiar with the code and product type of pharmaceutical machinery, pharmaceutical production requirements for equipment, GMP certification and verification of the basic requirements.
3, understanding of pharmaceutical machinery GMP review and testing of the content of the pharmaceutical machinery and equipment, the development of pharmaceutical machinery and equipment, and the basic content of the preparation workshop process design. 1, grasp the concept of crushing, mixing, granulation, process; hammer mill, universal pulverizer, ball mill, tank mixer, V-type mixer, swing granulator, rapid mixing and granulation machine structure principle; fluidized granulation mechanism, process and operation; factors affecting the mixing; freeze-drying equipment, characteristics, composition; liquid bridging principle.
2, familiar with pulverizer, mixer selection and validation points, boiling granulator and rapid mixing granulator validation points; freeze drying mechanism; rotating granulator; spray granulation process; spray granulation equipment in the form of atomizer.
3, understand the energy consumption of crushing; microfine classifier principle; mixing degree of representation; rotary granulator, dry granulator; hot air circulation oven and boiling dryer. 1, master the working process, principle and classification of the tablet press; single punch tablet press charging mechanism, filling regulator, pressure regulator and the working principle and regulation of the mechanism; the principle of the mechanism of the various parts of the tablet press; the operation of the tablet press and troubleshooting.
2, familiar with the quality requirements of tablets; the structure and selection of punching dies; tablet press, coating machine GMP verification points; coating equipment classification and structural characteristics.
3, understand the pressure of the tablet press and the method of compiling the model according to the punch die; high-speed tablet press main structure and features; program control airless spray coating device. 1, grasp the classification of capsules, advantages; hollow capsules storage conditions; automatic capsule filling machine process, the main station and role; common failures and treatment; automatic capsule filling machine GMP verification points; soft capsule machine composition, common failures and verification.
2, familiar with the composition and specifications of the capsule; capsule filling machine main components of the structural principle; semi-automatic capsule filling machine structural principle; the overall structure of the soft capsule machine.
3, understand the hard capsule manufacturing equipment; soft capsule machine structural principles; the structural principle of the capsule machine; the structure of the machine; the process and the main structure of the drip pill machine. 1, master the preparation of water for injection injection method classification and principle; plate and frame filter press working principle and the arrangement of plate and frame; colloid mill structure principle; cavitation principle.
2, familiar with the water for injection equipment; injection filling and sealing process; vacuum leakage detection compartment working principle; PE tube filter structure and operation; process water system validation; aseptic filling (portioning) validation; steam, dry heat sterilization equipment validation; validation of the liquid aseptic filter.
3, to understand the deionization method; the use of electrodialysis; the application of PE tubing; container treatment process. 1、Master the working principle of the pump in oral liquid filling and sealing; oral liquid system agent equipment verification. 2, familiar with oral liquid packaging methods; four pump linear filling machine production process.
3, understand the oral liquid bottle ultrasonic cleaning machine; oral liquid bottle sterilization equipment; oral liquid agent linkage line. 1, master the classification of cutting equipment, structural principle; leaching method of classification; traditional Chinese medicine leaching process, leaching equipment structure, working principle and use; pills plasticizing equipment.
2, familiar with the purification equipment, concoction equipment; moistening machine; multi-functional extraction tank, centrifugal spray dryer, pill machine verification.
3, understand the heavy impregnation and multi-stage countercurrent impregnation; leachate treatment equipment; pill characteristics, classification and preparation methods. 1, master the role of pharmaceutical packaging; commonly used plastic packaging materials and selection; the composition of composite packaging materials; electromagnetic induction bottle mouth sealing machine, aluminum-plastic packaging machine; multi-functional filling and packaging machine working principle and process.
2, familiar with the classification of pharmaceutical packaging; glass and metal packaging containers; pharmaceutical packaging technology; packaging materials sterilization methods.
3, understand the pharmaceutical packaging paper; bottling machine counting mechanism. 1, master the content of the general layout plan design; the composition of the general pharmaceutical plant; pipe laying methods and characteristics.
2, familiar with the general layout principles; people, logistics design principles.
3, understand the site selection and general layout of the regulations; adjacent building spacing. 1, grasp the significance and principles of process flow design; the significance of process flow diagram; tablets, capsules and sterilizable small volume injection process flow diagram.
2, familiar with the tasks, objectives and basic procedures of process flow design; process flow design of the basic method - program comparison;
3, understand the representation of the process flow diagram with control points. 1, master the representation of the material flow diagram; process equipment selection steps, precautions and basis; process equipment installation requirements.
2, familiar with material accounting and energy accounting and its application.
3, understand the preparation workshop energy saving. 1, master the clean room control items and air purification measures; commonly used plant cleanliness level and temperature and humidity, clean room pressure and other factors; clean room airflow organization and precautions; purification air-conditioning system air treatment process; purification air-conditioning system division principles; tablet workshop dust control measures.
2, familiar with the GMP requirements for environmental control of the clean room; pharmaceutical industry common differential pressure mode; clean room disinfection verification.
3, understand the number of air changes in the clean room; purification and air conditioning system installation and confirmation of the order, the determination of indoor cleanliness and the principle; the characteristics of a variety of filters; the main indicators of air filters. 1, master the significance of the workshop layout and task; workshop composition; workshop layout methods, steps, personnel and process requirements; personnel, logistics purification route; air shower room structure.
2, familiar with the overall requirements of the workshop; workshop layout; production of clean area requirements; tablets as an example of the production of supporting regional setting requirements and workshop layout program comparison.
3, understand the plant plan and building modeling system; injection workshop layout warehouse storage area requirements. 1, master preparation workshop on the pipeline requirements; the role of the valve; pipe connection; clean room requirements for floor drains.
2, familiar with the significance of stainless steel material; pipe diameter representation.
3, understand the selection of pipes, valves and fittings; clean plant piping design. 1, master the extraction of the production process and layout requirements; pretreatment workshop, extraction workshop layout principles.
2, familiar with the production process flow diagram design and examples; multi-storey extraction plant layout principles.
3, understand the basic composition of the production process flow diagram; production process flow diagram contains information.