I.Explain the Glossary:
i. Cleaning In Place: The CIP cleaning system is an ideal method for cleaning equipment and pipes. The device does not have to be disassembled. It use the configured pipeline valve to introduce clean water to clean the equipment;
ii. Sterilizing in Place: SIP is a method that uses configured pipes, valves and heaters to import saturated steam or high-temperature air for sterilization of the equipment. Maintain the specified temperature and pressure for a specified period of time to facilitate the killing of bacteria that may remain in the treated device;
iii. Air Binding: When the centrifugal pump is started, if the pump casing and suction pipe are not filled with liquid, there is air inside the pump casing. Because the density of the air is smaller than the density of the liquid, the centrifugal force generated is small, therefore, the negative pressure formed in the center of the impeller is not enough to suck the liquid in the tank into the pump, and even if the centrifugal pump is started, the liquid cannot be transported. This phenomenon is called “air binding”. Air binding indicates that the centrifugal pump has no self-priming ability;
iv. Cavitation: When the centrifugal pump runs, if the pressure in a certain place in the pump is lower than the liquid gasification pressure at the temperature at that time, the liquid will begin to vaporize and bubbles will be produced; It is also possible to precipitate the gas dissolved in the liquid and form bubbles. When the bubbles run with the liquid to the high-pressure area of the pump, the gas begins to condense again, causing the bubbles to burst. Due to the extremely fast bursting speed of the bubble, the surrounding liquid rushes to the space occupied by the bubble before their bursting at a very high speed, and produces a strong hydraulic impact, causing damage to the surface of the pump runner, and even penetration. This phenomenon is called cavitation.
v. molecular distillation: Molecular distillation is a technology that under an extremely high vacuum, according to the difference in the average free path of the molecular motion of the mixture, the liquid at a temperature below the boiling point will be the separation. Molecular distillation technology is a new type of special technology for fractionation or refining, which successfully solves the problem of separation and purification of high boiling points and heat-sensitive materials. Molecular distillation technology breaks through the principle of conventional distillation separating substances according to the boiling point difference and has incomparable advantages to conventional distillation, such as low distillation pressure, short heating time, and low operating temperature and a high degree of separation.
[Complete molecular distillation systems include: degassing systems, feed systems, molecular stills, heating systems, vacuum cooling systems, receiving systems and control systems.]
vi. Vacuum freeze drying: Vacuum freeze drying is a drying process in which the material or solution is frozen into a solid state at a low temperature (such as -10 ~ -50°C), and then the moisture in it is directly sublimated into a gaseous state without being liquid under vacuum. Freeze drying can be divided into three stages: pre-freezing, sublimation and analytical drying.
(1) Pre-freezing: It is to freeze the product at normal temperature and make it enter a state suitable for sublimation drying.
(2) Sublimation: After the product is pre-freezing, the vacuum pump is activated, and the sublimation of the ice begins. The sublimation of ice is carried out on the surface, and then enters into the interior of the product, and when the ice crystals in the product are all sublimated completely, the sublimation stage ends.
(3) Analytical drying: The purpose is to remove the residual moisture bound in the form of adsorption in the product to ensure the long-term storage of the product. It can be heated up without affecting product quality to promote the precipitation and overflow of water.
vii. Intergranular corrosion: In the temperature range of 400 to 800°C, carbon precipitates from austenite in the form of chromium carbide (Cr23C6) along the grain boundary, so that the chromium content of alloying elements (chromium and nickel) near the grain boundary is reduced to the minimum content required for corrosion resistance (12%), and corrosion is generated in this chromium-poor area. This corrosion along the grain boundaries is called intergranular corrosion.
[Methods to prevent intergranular corrosion: ① Add elements such as titanium, niobium, etc., which have a stronger affinity with carbon than chromium, to form stable TiC, NbC, etc., to reduce the tendency of intergranular corrosion. ② Reduce the carbon content in stainless steel ③ Some weldments can be reheated to redissolve the carbon-chromium in the austenite. ]
II.The Basic Introduction of Tablet Machine
Tablet machine is a kind of machine that places raw materials in die holes and presses them into a tablet with a punch.
i.Working principle:
(1)Punching and die is the basic components of the tablet press, which is composed of a top punch, medium die, and bottom punch.
(2)Working process of tablet machine:
① The head of the bottom punch (its working position is facing upwards) protrudes from the lower end of the middle die hole into the middle die hole and seals the bottom of the middle die hole;
② Use the feeder to fill the middle die hole with medicine;
③ The head of the top punch (its working position is facing down) falls from the upper end of the middle die hole into the middle die hole, and descends a certain stroke to press the powder into tablets;
④ Top punch is withdrawn. Lower punch is pushed up and expels the tablet, and one pressing process is down;
⑤ The bottom punch withdraws and is ready for the next pressing process;
ii. The Principle of Tablet Production
(1) Control of the dose. Various tablets have different dosage requirements. Large dose adjustments are achieved by selecting dies with different punch diameters. After selecting the die size, the small dose adjustment is to adjust the depth of the punch into the die hole, thereby changing the actual length of the middle die hole, to adjust the filling volume of the drug in the die hole. Therefore, on the tablet machine, there should be a mechanism that adjusts the original position of the punch in the die hole to meet the dose adjustment requirements.
(2) Control of tablet thickness and degree of compaction. The dosage of the drug is determined according to the prescription and pharmacopeia and cannot be changed. To store and transportation, store and meet the time limit of disintegrating, there are also requirements of pressure for a certain dose when pressing the tablets, which will also affect the actual thickness and appearance of the tablets. Pressure regulation is mostly achieved by adjusting the mechanism of the upward and downward impulse volume.
[Rotary tablet machine. Transmission system, feeding mechanism, filling adjustment mechanism, guide rail device for up and down punch]
iii. The main process of tablet production and the production equipment used
(1)Basic Process: Raw materials and accessories→crushed, sieved→mixed→soft materials→ wet granules→dried→whole grains→tablets
(2) Equipment Used: disintegrator (ball mill, etc.), screening equipment (rotary screen, etc.), mixing, soft material making, granulation equipment (double cone mixer, etc.), granulation equipment (pendular granulator, etc.), drying equipment (box type dryer, etc.), tableting equipment (single punch tableting machine, etc.)
III . Basic Introduction of Capsule Filling Machine:
i. The main component of the capsule filling machine: Main working plate, empty capsule sorting and directional device, capsule extraction device, waste capsule removal device, closed capsule device, bladder out device and cleaning device;
ii. Characteristics of capsules: Beautiful appearance, easy to take, cover up the bad odor, improve drug stability, control drug release;
iii. Capsule filling process
(1)When working, the chaotic empty capsules falling from the hopper are arranged into the state of the capsule cap on the top after being sorted and oriented, and fall into the upper capsule plate hole of the main working plate one by one;
(2)In the capsule extraction area, the capsule extraction device uses vacuum suction to make the capsule fall into the hole of the lower capsule plate;
(3)In the misaligned area of the body cap, the upper capsule plate is removed along with the capsule cap so that the upper opening of the capsule is placed under the filling device;
(4)In the filling area, the dosing device fills the medicine into the capsule;
(5)In the waste capsule reject area, the reject device removes the unplugged empty capsule from the upper sac plate well;
(6)In the capsule closure area, the axes of the upper and lower capsule plate holes are aligned, and the capsule is closed with the capsule by applied pressure;
(7)In the bag discharging area, the closed capsule is pushed out of the bag plate hole by the bag discharging device, and enters the packaging process through the bag discharging chute;
(8)In the cleaning area, the cleaning device removes contaminants such as medicinal powder and capsule dander in the holes of the upper and lower capsule plates. Then enter the next operating cycle;
iv. Hard capsule filling device: intubation quantitative device, template quantitative device, template dosing device, piston-slider dosing device, vacuum quantitative device.
IV. Basic introduction to powder injection dispensing
There are two main types of powder injection dispensing: screw dispenser and airflow dispenser.
i. Screw Dispenser: Use the intermittent rotation of the screw to load the drug into the bottle to achieve the purpose of quantitative dispensing. The powder is placed in the hopper, and there is a falling powder head in the lower part of the hopper, and there is a unidirectional intermittent rotation metering screw inside. Every rotary has the same volume and there is a symmetrical and appropriate amount of clearance (about 0.2mm) between the metering screw and the wall of the feed delivery pipe. When the screw rotates, the powder in the hopper is moved along the shaft to the nozzle and falls into the medicine bottle below the nozzle. The accurate measurement of the powder can be obtained by precisely controlling the rotation angle of the screw. In order to make the powder dosing evenly, there is also a stirring paddle in the hopper, which is continuously rotated in reverse to loosen the powder.
ii. Airflow Dispenser：Vacuum is used to aspirate the quantitative volume powder, and the powder is blown into the packaging container by purified dry compressed air. The stirring paddle in the powder mixing bucket rotates once every time after the powder is sucked, and its function is to keep the powder loose after falling from the powder filling bucket, and assist the powder to be loaded into the quantitative dispensing hole of the powder dispensing head. When access to vacuum, the powder is sucked into the quantitative dosing hole and blocked by the powder adsorption isolation plug, allowing the air to escape; When the powder filling head rotates 180° C to the powder loading station, the purified compressed air blows the powder into the bottle through the powder blowing valve. The rear surface of the dispensing panel has the same number of holes as the powder-filling holes and the same round holes as the powder-filling holes. The distribution panel is connected with vacuum and compressed air to realize the powder suction and discharge of the dispensing head during the intermittent rotation. When the bottle is short in supply, the machine will stop automatically, and the powder in the measuring hole will be collected and reused after waste powder recovery.
V. Classification and Working Principle of Coating Machine
i. Roll-on coating equipment. Principle: Spray the coating liquid on the surface of the tablet and the liquid suspends it in the air at a certain flow rate, and at the same time heat the air to volatilize the solvent on the surface of the tablet to form a film.
ii. Fluidized bed coating equipment. Principle: The coating liquid is sprayed on the surface of the tablet and suspended in the air at a certain flow rate, and at the same time, the air is heated to volatilize the solvent on the surface of the tablet to form a film.
iii. Pressing and coating equipment. Principle: Wrapped in coating material, it is pressed and formed directly on the tablet press. (dry coating)
iv. The difference between common coating equipment and pressing and coating equipment:
(1) The outer shape of the machine. The common coating pan is in the shape of a chufa.
(2) Applicable objects. Common coating pot is for sugar coating, film coating and enteric coating; The pressing and coating machine can be used for sugar coating, enteric coating or drug coating, and it is suitable for coating medicines sensitive to dampness and heat and is also suitable for the preparation of long-acting multi-layer tablets or the coating of drugs with compatibility contraindications.
(3) Principle. The common coating machine sprays the coating liquid on the surface of the tablet and the liquid suspends in the air at a certain flow rate, and at the same time heats the air to volatilize the solvent on the surface of the tablet to form a film. While the pressing and coating machine is wrapped in coating material, it is pressed and formed directly on the tablet press.
VI. The measurement method and working principle of infusion solution filling:
i. The flowing timing type;
ii. Measuring cup volumetric type: In terms of volumetric quantification, the liquid exceeds the flow gap and automatically flows from the gap into the filling cylinder, which is the coarse positioning of the measurement. Error adjustment is determined by the volume of the metering block in the jigger, and the adjustment nut to make the metering block rise or fall, to achieve the purpose of accurate filling. The pipette is connected to the vacuum line, so that liquid in the metering cup flows into the infusion bottle because of the negative pressure. The pit in the lower part of the metering cup makes the liquid fully used.
iii. Metering pump syringing type: The metering pump is filled with the reciprocating motion of the piston and filled at atmospheric pressure. The principle is also measured by volume. First of all, the rough piston stroke is adjusted to achieve the filling volume, and the filling accuracy is adjusted by the fine-tuning nut of the lower part, which can achieve high metering accuracy.
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