1.Design requirements for the functionality of pharmaceutical equipment：
(1)Purification function;
(2)Cleansing function;
(3)Online monitoring and control function;
(4)Safety protection function;
2.GMP has the following requirements for pharmaceutical equipment:
(1)It should have the equipment capacity suitable for production and the most economical, reasonable and safe production operation;
(2)It should have perfect functionality and multiple adaptability to meet the requirements of pharmaceutical processes;
(3)It can ensure the consistency of quality in drug processing;
(4)Easy to operate and maintain;
(5)Easy to clean the inner and outer parts of the equipment;
(6)It should have various interfaces to meet the requirements of coordination, matching and combination;
(7)Easy to install and easy to move, which provides the possibility of combination;
(8)Equipment verification (including type, structure, performance, etc.);
3.Granulation methods widely used in pharmaceutical production can be classified as:
wet granulation, dry granulation and spray granulation. High-efficiency mixing granulator is a device that turns wet materials into granules by mixing with agitators and cutting with high-speed granulators. Function: mixing and granulation;
4.Reactor with a stirring device :
Reactor with a stirring device is a batch reactor widely used in pharmaceutical industry. There are three flow types of agitators: radial flow, axial flow and tangential flow;
5.Some typical agitators:
(1)Paddle agitator: Paddle agitators have a large radial mixing range and can be used for mixing high viscosity liquids;
(2)Anchor and frame agitators are commonly used for mixing medium and high viscosity liquids;
(3)Helical ribbon agitator: purpose: The liquid will rise or fall along the helicoid to improve the axial mixing effect, forming an axial circulation flow; Helical ribbon agitator is often used for the mixing of high viscosity liquids;
6.The structural differences between fermentation equipment and the reactor:
Fermentation equipment has defoaming paddles and vent pipe; In fermentation tanks, disc turbine agitators are widely used;
7.Cyclone separator:
Cyclone separator is dry gas-solid separation equipment that separates dust from the airflow by using the centrifugal force generated by the high-speed rotating gaseous heterogeneous phase. It has a simple structure and strong operating flexibility. For trapping dust above 5~10μm, the efficiency is high but for the separation of the fine dust, the efficiency would be lower. A bag filter is a kind of separation equipment that uses filter material to separate solid particles from dusty gases. The separation efficiency of 1~5 μm fine particles is more than 99%, and the dust particles of 1 micron or even 0.1 microns can be removed, but the filtration efficiency is low;
8.Leaching equipment types according to leaching method:
Decoction equipment; impregnation equipment; seepage equipment; reflow devices；
9.The principle of ultrasonic extraction
The principle of ultrasonic extraction is to use the cavitation effect, mechanical effect and thermal effect of ultrasonic waves;
10.The principle of membrane separation:
Membrane is a molecular level separation and filtration medium, when the solution or mixed gas comes into contact with the membrane, under the action of pressure, electric field or temperature difference, some substances can pass through the membrane, while other substances are selectively intercepted, so that different components in the solution or different components of the mixed gas are separated, this separation is molecular level separation;
11.There are many types of membranes, which can be divided into two categories:
Organic high polymer membranes and inorganic membranes. At present, the most widely used material in pharmaceutical industry production is polysulfone (PS) materials, accounting for about 32%; Cellulose materials, Cellulose acetate (CA) and cellulose triacetate (CTA) account for 13% and 7% respectively; Polypropylene (PAN) accounts for 6%; Inorganic membranes accounted for 22%; Other membrane materials are about 20%;
12.Classification of tubular thin film evaporator:
Climbing-film evaporator, falling-film evaporator and climbing-falling film evaporator. The climbing-film evaporative concentration equipment refers to the liquid film formed in the evaporator in the same direction as the evaporated secondary steam gas flow, rising from bottom to top. It is composed of four parts: evaporative heating tube, secondary steam foam catheter, separator and circulation tube;
13.Tubular thin film evaporator:
The liquid evaporates along the wall of the heating tube into a film; Scraper evaporator: An evaporation device that forms a liquid film by means of a rotating scraper; Centrifugal thin film evaporator: A thin film is formed by the centrifugal force generated by the rotating centrifugal disc on the periphery of the solution;
14.The principle of molecular distillation:
Molecular distillation is the rapid separation of liquid at a temperature well below its boiling point under an extremely high vacuum, depending on the difference in the mean free path of the molecular motion of the mixture;
15.The free path of molecular motion:
The free path of molecular motion refers to the distance traveled between two collisions of a molecule adjacent to another molecule. The free path of molecular motion refers to the average of the free path over a time interval;
16.Drying equipment:
Tray dryer, belt dryer, fluidized bed dryer, spray drier, vacuum desiccator, vacuum freeze dryer, microwave vacuum desiccator;
17.Process water
Process water is the water used in the pharmaceutical production process, including: drinking water, purified water and WFI;
18.Sterilization:
Physical sterilization, chemical sterilization, aseptic operation. Physical sterilization: dry heat sterilization, moist heat sterilization, radicidation, filtration sterilization. Physical sterilization is widely used in the pharmaceutical industry;
19.Principle of dry heat sterilization: Principle of thermal sterilization:
Heating can destroy the hydrogen bond in proteins and nucleic acids, so it leads to nucleic acid destruction, protein denaturation or coagulation. Enzymes lose their activity and microorganisms die. Dry heat sterilization includes flame sterilization, dry heat air sterilization and the high-speed hot air sterilization method. Dry heat sterilization equipment: oven, dry heat sterilization cabinet, tunnel fire sterilization system.
20.Principle of moist heat sterilization:
Moist heat sterilization is a method of killing bacteria using saturated water vapor or boiling water. Due to the large latent heat of steam, and its strong penetration, it is easy to denature or coagulate proteins, so the sterilization efficiency is higher than that of dry heat sterilization. The disadvantage is that it is not suitable for drugs that are sensitive to damp heat. Moist heat sterilization includes pressure sterilization, flowing steam sterilization, boiling sterilization and low-temperature intermittent sterilization. Moist heat sterilization equipment: heat pressure sterilizer, heat pressure sterilization cabinet.
21.The process of ampoule filling and sealing generally includes:
Ampoule arranging in order, filling, inflation, sealing and other processes. The filling part is mainly composed of a cam lever device, a suction and filling device, and a bottle-defusing device.
22.For ampoules produced by the sterilization method:
For ampoules produced by the sterilization method, sterilization, disinfection and leak hunting are often carried out immediately after the filling and sealing processes.
23.Metering adjustment mode:
Masuring cup metering and metering pump metering;
24.Types of packaging for tablets and capsules:
(1)Strip packaging, mainly heat-sealing packaging in strip shape;
(2)Blister packaging;
(3)Bulk packaging like bottle packaging or bag packaging;
25.Classification of pharmaceutical packaging:
(1)Unit dose packaging;
(2)Interior package;
(3)Exterior package;
26. Pharmaceutical engineering design can generally be divided into three main stages:
Pre-design work(including a proposal of the term project, site selection report, pre-feasibility study report and feasibility study report), preliminary design and construction drawing design. The design of construction drawings is one of the most onerous sectors of the work of the design department;
27.Plant site selection:
The distance between the fresh air outlet of the clean workshop of the pharmaceutical industry and the red line of the municipal traffic road near the base side road should be greater than 50m. GMP requires that pharmaceutical manufacturers must have a clean production environment. In general, the pharmaceutical factory is best selected in the area with good atmospheric conditions, with less air pollution, and no water and soil pollution, and try to avoid areas with much pollution like lively urban areas, chemical industry areas, aeolian sand areas, railways and highways. So in this case, the air, site, and water quality of the environment in which the pharmaceutical manufacturer is located can meet the production requirements;
28.Principles of process design:
(1)As far as possible, advanced equipment, advanced production methods and mature scientific and technological achievements are used to ensure product quality
(2)”use local materials”, to make full use of local raw materials to achieve the best economic results;
(3)The equipment used is highly efficient, reducing the consumption of raw materials, water and electricity and also the cost of the product;
(4)According to GMP requirements, every pharmaceutical dosage form should have its process design. Such as oral solid preparations and suppositories are designed according to the conventional process route; External lotions, oral solutions, and injection solutions (large infusions, small injections), are designed according to the sterilization process route; The sterile powder for injection should be designed with aseptic production process;
(5)β-lactam drugs (including penicillins and cephalosporins) are designed according to the process flow of separate building plants. Traditional Chinese medicine preparations and biochemical pharmaceutical preparations involve the pretreatment, extraction, and concentration (evaporation) of Chinese herbal medicines as well as the washing or treatment of animal organs, tissues and other production operations, according to the pretreatment process design should be arranged in the separate pretreatment workshop, and shall not be mixed with the production process design of their preparations;
(6)Other such as contraceptives, hormones, antitumor drugs, production toadstool species, non-production toadstool species, cells for production and non-production cells, strong and weak, dead and live venom, live vaccines before and after detoxification and inactivated vaccines, human blood products, preventive products dosage forms and preparations, all should be designed and produced according to their special requirements for the process design;
29.Workshop layout design content in the preliminary design phase:
(1)According to the “Good Manufacturing Practice and Quality Control of Drug (GMP and QC of Drug)”, determine the cleanliness level of each process in the workshop ;
(2)Production process, production auxiliary facilities, living administrative auxiliary facilities of the flat, three-dimensional layout;
(3)Workshop’s site and buildings, location and dimensions of structures;
(4)Flat, three-dimensional arrangement of the equipment;
(5)Aisle system, material transport design;
(6)Flat and space design for installation, operation, and maintenance;
30.The content of layout design during the construction design phase:
(1)Implement the content of the workshop layout in preliminary design;
(2)Determine the orientation and elevation of the equipment nozzle and instrument interface;
(3)Material and equipment movement, transportation design;
(4)Determine the dimensions of the building about the installation of the equipment;
(5)Determine the equipment installation scenario;
(6)Arrange the direction of pipes, instruments, electrical pipelines, determine the location of the pipe gallery;
31.The content of the piping design:
(1)Select the pipe;
(2)Pipeline calculation;
(3)Design of pipeline layout;
(4)Design of pipeline insulation;
(5)Design of pipeline support;
(6)Write a design specification;
32.According to usage clean rooms are divided into:
Industrial clean rooms and biological clean rooms; the environment of the pharmaceutical production workshop can be divided into: the general production area, control area and clean area;
33.According to the degree of treatment, wastewater can be divided into primary, secondary and tertiary treatment:
(1)Primary treatment usually uses physical methods or simple chemical methods to remove floating matter and pollutants in the partial suspension state in the water, as well as to regulate the PH of wastewater. The pollution degree of wastewater and the load of subsequent treatment can be reduced through primary treatment. Primary treatment is often used as a pretreatment of wastewater;
(2)Secondary treatment mainly refers to biological treatment. After the primary treatment of the wastewater, and then after the second-level treatment, most of the pollutants in the wastewater can be removed and the wastewater can be further purified. Secondary treatment is suitable for treating a variety of wastewater containing organic contaminants. After the secondary treatment, the water quality can generally meet the specified discharge standards;
(3)Tertiary treatment is a kind of treatment with a high degree of cleanliness requirements, the purpose of which is to remove pollutants that cannot be removed in the secondary treatment, including the organic matter that cannot be decomposed by microorganisms, soluble inorganic substances (such as nitrogen and phosphorus, etc.) that can lead to eutrophication of water bodies, as well as various viruses, pathogens, etc. After tertiary treatment, the water quality requirements of surface water and industrial water can be met;
34.Clean Production:
It refers to improving the design continuously, using clean energy and raw materials, advanced technology and equipment. Also, it refers to improving management, comprehensive utilization and other measures to reduce from the source, improve the efficiency of resource utilization, and reduce or avoid the production, service and product use of pollutants in the process of generation and emission, in order to reduce or eliminate the harm to human health and the environment.
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