The common solid dosage forms are powder, granule, tablet, capsule, drop pill, film etc., which account for about 70% of pharmaceutical preparations. The common characteristics of solid preparations compared with liquid preparations, good physical and chemical stability, lower manufacturing cost, and easy to take and carry. No matter what production process, the granulation procedures at the first stage of tablet, capsule and granule production are similar, such as mixing, granulation, drying and sorting etc. The main equipment are: granulator, grinding and granulate machine, general mixer, tablet machine / capsule filling machine, coating machine, etc.
Technical Features Description
▶ Granulation is the operation of processing materials in the state of powder, melting liquid and aqueous solution into particles of certain shape and size. The preparation process of almost all solid preparations is inseparable from granulation process. The particles may be finished products, such as granules, or intermediate products, such as tablets.
▶ The principle of granulation: the granulation operation makes particles have some corresponding purposes, so as to ensure product quality and smooth progress of production. For example, if particles are products in granules and capsules, the purpose of granulation is not only to improve fluidity, dispersion and adhesion of materials, and to facilitate accurate measurement and protect production environment, but also to ensure the uniform shape and size of particles, beautiful appearance and so on. In the production of tablets, particles are intermediate products, it is not only to improve fluidity to reduce weight difference of tablets, but also to ensure compression formability of particles. There are many different kinds of granulation methods, even if the same prescription, granulating content not only has different shape, size and strength, but also has different disintegration and solubility, resulting in different pesticide effect. Therefore, the suitable granulation method should be selected according to characteristics of the required particles.
▶ The common granulation methods: wet granulation, one-step granulation, dry granulation and spray granulation.
▶ The purpose of granulation:
a、To improve liquidity. Generally speaking, the particle size of particle is larger than one of powder, and the number of particles that can be contacted around each particle is less, so adhesion and agglutination are greatly weakened, thus greatly improving fluidity of material. Although material is solid, but it can be treated as quantitatively as liquid.
b、To prevent separation of various components. It is prone to segregation when particle size and density of each component of the mixture are different, and segregation can be effectively prevented by granulation after mixing or mixing after granulation.
c、Prevent dust flying and adhesion on the wall. The dust explosion and adhesion of powder are serious. After granulation, environmental pollution and the loss of raw materials can be prevented, which is beneficial to GMP management.
d、Adjust packing density to improve solubility;
e、Improve the uniform transmission of pressure in tablet production;
f、Easy to take and carry, improve value of commodity.
2. Grinding and Granulate Machine
▶ The machine has the advantages of fast granulating and good effect. The strainer with special hole is designed and filtered carefully. The friction filter rod can break the sieve and filter particles. This machine can replace swinging granulator. It is a new type of machine designed and manufactured according to GMP requirements of drug production. The whole machine is sealed with high-quality stainless steel plate. The appearance of the whole machine is neat and beautiful, especially screen is made of wire mesh or stainless steel mesh, which improves quality and economic efficiency of particles greatly.
▶ The machine is mainly used for dried agglomerated particles in pharmaceutical industry, sorting out qualified uniform particles according to the process requirements, and for mixer and tablet press. It is widely used in API, chemical, food and other industries;
▶ Usage: Crushing and granulation of coarse granular raw materials, caking raw materials, tablets that do not meet the requirements; crushing and recycling of heat-sensitive food, greasy and cream biscuits.
▶ Performance Features:
a、Less heat and less dust at work
b、The stator screen is made of stainless steel and not easy to damage.
c、Adjustable Clearance between crushing knife and screen
3. General Mixer
▶ Mixing refers to the operation process in which velocity and direction of the material changes under the influence of external forces (gravity and mechanical force, etc.), so that the particles of each component can be evenly distributed. It is also called homogenization process.
▶ Classification: according to mixing movement mode, powder mixer is divided into V-type mixer, two-position mixer, three-dimensional mixer and double-cone mixer.
▶ It can be used to mix solid particles and powder, particles and particles, powder and powder in pharmaceutical production. It has the advantages of good mixing effect, no cross pollution and dust pollution. It fully meets the GMP requirements of pharmaceutical production, and realizes the function of on-line material distribution.
▶ The mixer adopts PLC and frequency conversion speed regulation to realize program control, and the performance is stable and reliable.
▶ Mixing Time: 15~30min/ batch (depending on specific material)
▶ Loading Factor: barrel volume * (40-80%)
▶ Suitable Ambient Temperature: normal working ambient air temperature is 5 ℃ ~ 40 ℃.
▶ Applicable Environmental Humidity: when ambient temperature is 40 ℃, relative humidity of the working environment does not exceed 95%, and higher humidity is allowed at lower temperatures (for example, when ambient temperature is 20 ℃, relative humidity of the working environment does not exceed 90%).
4. Tablet Machine
▶ The machine is an equipment for pressing all kinds of granular raw materials into tablets in pharmaceutical, chemical, food, electronics and other industries; it is suitable for mass production of round or special-shaped tablets, sugar tablets, calcium tablets, etc., but it is not suitable for powder pressing of semi-solid, wet powder and small particles (≥ 100 mesh).
▶ The work flow includes filling metering, prepressing, main pressing and unloading etc.
▶ The machine is equipped with transparent glass doors and windows, which can clearly observe the state of pressing tablets, and the side panels can be fully opened, which is easy for internal cleaning and maintenance.
▶ The outer cover is fully enclosed, which is made of stainless steel, and the internal table is made of stainless steel, which can maintain surface luster and prevent cross contamination, and meet the requirements of GMP.
▶ It can be equipped with dust collector, which can remove dust automatically.
▶ The frequency conversion speed regulation device is used for electric speed regulation, it is easy to operate, steady running, safe and accurate.
▶ The system includes an overload protection device to avoid damage to die and equipment; when machine is overloaded, it will stop automatically.
▶ The wear parts, such as upper track, feeder, hopper, transmission worm, powder meter, adopt standardized, universal and serialized design.
5. Capsule Filling Machine
▶ The machine adopts hole plug filling, intermittent operation and frequency conversion speed regulation, which is suitable for powder or pellet capsule drugs to automatically complete sowing, dividing, filling, (waste bag removal) lock bag, finished product output and so on. The latest structure: fully enclosed ten-station turntable has the characteristics of high precision, low noise and strong adaptability to domestic mechanism capsules. Its bearings of key parts and electrical appliances are international famous brands, with stable performance and high-speed operation. The parts in contact with drugs are all made of high quality stainless steel, with vacuuming device, which meets the requirements of GMP standard.
▶ Capsule Loading Probability: 99%
▶ Production Capacity: 200-3500 granules/min
▶ Number of die holes: 2-25 pieces
▶ Applicable Rubber Plugs: 00#-04#
▶ Small transmission vibration, the working noise of high speed operation is less than 75dB, and the dose difference is within 3%.
▶ Good lubrication condition and no oil pollution on work table, which avoids cross-contamination with drugs.
▶ Small in size, low energy consumption, quick mold replacement, convenient operation and easy cleaning.
▶ The lower cam design and pressure atomization oil pump, which fully maintain lubrication inside cam groove, reduce wear and prolong the service life of parts.
▶ The machine adopts man-machine interface, PLC programmable controller, liquid crystal display output per minute, cumulative output, dynamic empty capsule and powder status, lack of capsule alarm prompt and automatic stop when powder is not enough, fault diagnosis prompt, etc.
6. Coating Machine
▶ Inside clean and airtight rotating drum of the machine, film core constantly makes complex trajectory movement, flipping smoothly and exchanging frequently. The coating medium stirred by constant temperature mixing tank is sprayed from spray gun to film core through peristaltic pump. At the same time, under action of hot wind and negative pressure, class 100000 clean hot wind supplied by hot air cabinet passes through core, and then discharged from air door through the bottom sieve hole, so that coating medium can be dried quickly on the surface of core to form a solid, compact and smooth surface film. The whole process is completed automatically under the control of PLC.
▶ The machine is widely used in pharmaceutical, food, biological products and other fields. it can make all kinds of organic film, water-soluble film and sugar coating for all kinds of tablets, pills, sweets.(The effect of slow and controlled release can be realized in the aspect of drugs.) The whole machine has the advantages of beautiful appearance, high efficiency, low energy consumption, small area and so on.
▶ There is no dust and slurry spatter in the whole coating process, which improves working environment and reduces cross pollution of tablets. The process of tablet coating is simple, the coating time is greatly shortened and the production efficiency is improved.
▶ Drug-loading Rate: 5-600L
▶ A new type of microcomputer temperature and negative pressure module control system and touch screen graphic display and control are adopted, which has programmable function.
▶ It can automatically adjust most of process parameters, such as flow rate, negative pressure, inlet air volume, exhaust air volume, temperature, speed, etc., so that the compilation of standard operation procedure (SOP) can be digitized. Different batches of goods can be produced with the same technical parameters, so that the difference between batches is close to zero.
▶ The machine can be configured with data storage and printing functions: a variety of programs for automatic sugar coating and film coating can be modified at any time during operation; a printing device can be equipped according to customer requirements, so that process parameters and process flow of each batch of production can be truthfully recorded.
▶ Automatic in-place cleaning system can be configured: there is a high-pressure spray gun inside and outside coating pot, and a cleaning nozzle is provided at air outlet and hot-air outlet, which can rotate automatically in all directions, no dead corner, more convenient and easier cleaning.
▶ A professional customized spray gun can be used, which is strictly according to GMP and coating technology; all stainless steel design, easy to operate disassemble without any tools, flexibly control process requirements, prevent dripping and clogging, flow, angle and fan can be adjusted; uniform atomization, large spray surface, saving auxiliary materials
▶ The machine contains a mechanical device for coating in large container, and through its inherent mechanical adjustment, a small amount of plain tablets are coated in a large cylinder, which will not cause waste of auxiliary materials and greatly improve scope of use.