Solid oral preparation GMP workshop
Solid oral preparation GMP workshop
Oral solid preparations in the GMP pharmaceutical cleanroom are used as a wide range of dosage forms, including granules, tablets and capsules, etc. The characteristics of granules are fast absorption, rapid effect, easy to carry, and the basic quality requirements are dry, uniform particles, consistent color, no Moisture absorption, softening, caking, deliquescence and other phenomena...
Text label: solid preparation GMP workshop, clean pharmaceutical cleanroom design, installation and decoration
GMP pharmaceutical cleanroom for solid oral preparations
Oral solid preparations in the GMP workshop are used as a wide range of dosage forms, including granules, tablets and capsules, etc. The characteristics of granules are fast absorption, rapid effect, easy to carry, and the basic quality requirements are dry, uniform particles, consistent color, no Moisture absorption, softening, agglomeration, deliquescence and other phenomena, it should be sealed and stored in a dry place; capsules are made by filling the active ingredients and suitable auxiliary materials into hollow hard capsules or sealing them in elastic soft capsules. The prepared solid preparation is mainly used for oral application; the tablet is made of granules of quantitative volume, which are compressed in a die at a fixed position. In order to dry the solid, it can be protected by coating, light, air, moisture, etc. have little influence on it, and it is more convenient to carry and transport, and the mechanized production output is large, which is convenient to achieve economies of scale. The tablet production process includes ingredients, granulation, drying, granulation, mixing, tableting, tablet coating, inner packaging, outer packaging and other steps.
Production process of solid preparation: weighing, batching, granulation, drying, granulation, mixing, tableting, coating, capsule filling, inner packaging and outer packaging of raw and auxiliary materials; granule production process: included in In the process of tablet production, from batching to granulation, directly packaging after mixing, but without the tableting process; capsule production process: weighing, batching, granulating, drying, granulating, mixing, capsules Filling, inner packaging and outer packaging. The purpose of granulation is to improve fluidity, avoid cohesion, prevent segregation of components, prevent powder from flying and adhere to the wall of the vessel, adjust bulk density, improve solubility, improve uniform pressure transfer in tablet production, easy to carry, and improve product quality. value, etc.; granulation is usually divided into wet granulation and dry granulation. The screw extrusion granulator is composed of two parts: a mixing chamber and a granulating chamber. The material is fed from the feeding port above the twin screws in the mixing chamber. The two screws are driven by gears to face each other. With the help of the thrust of the screw on the screw, the material is extruded. Granulation chamber; the material is further squeezed by the extrusion drum in the granulation chamber, and becomes granules through the sieve holes on the sieve cylinder; the screw extrusion granulator has a large production capacity, and the obtained granules are stronger and not easily broken. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean workshops.
GMP workshop rotary granulator, a replaceable sieve ring is placed in a circular ring screen frame driven by a motor, and there is a roller in the screen ring that can rotate freely or driven by another motor, and put into the sieve The wet material in the ring is extruded through the sieve holes by the co-rotating rollers and the sieve ring to form particles; the pressure of extrusion granulation is adjusted by the distance between the roller and the sieve ring, and the particle size of the particles can be changed by replacing the sieves with different apertures. The rotating speed of the sieve ring is about 100r/min, and its production capacity depends on the fluidity, particle size, moisture, content, shape of the sieve hole and the rotating speed of the sieve ring, etc. It is characterized by less heat generation, large processing capacity, and reliable operation. . The GMP workshop rocking granulator is the most commonly used granulation equipment. The granules produced are closer to spherical and have a smoother surface. Large and smooth particles are usually made of nylon screen. Because the screen bears a large friction force and is easy to wear, the screen plate can be punched from a whole stainless steel plate instead. The swing type granulator has a simple structure and is easy to operate. , The characteristics of convenient assembly and disassembly and cleaning.
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