Precautions for pill production in GMP workshop
Precautions for pill production in GMP workshop
The GMP workshop plastic method is a common method for pill preparation. The process flow of pill preparation is: preparation of raw and auxiliary materials → pill making block → pill making strip → granulation → rounding → drying → whole pill → quality inspection → packaging. Honey is the main excipient of honey pills, the main components are glucose and fructose, ...
Text label: GMP pharmaceutical cleanroom purification, GMP workshop installation
Precautions for Pill Production in GMP
The GMP pharmaceutical cleanroom plastic method is a common method for pill preparation. The process flow of pill preparation is: preparation of raw and auxiliary materials → pill making block → pill making strip → granulation → rounding → drying → whole pill → quality inspection → packaging. Honey is the main excipient of honey pills. The main components are glucose and fructose. In addition, it contains a small amount of organic acids, microorganisms, enzymes, etc. The honey used for preparing honey pills should be a translucent glossy thick liquid, white to Light yellow or orange to yellowish brown, the relative density at 25°C should be above 1.349, and the reducing sugar should not be less than 64%; the aroma is sweet but not sour, clean and free of impurities, and it should be free of starch and dextrin when checked with iodine test solution. The purpose of refining honey is to remove impurities, reduce moisture content, destroy enzymes, kill microorganisms, and increase viscosity.
Pill making should pay attention to the degree of honey refining. If it is too tender, the viscosity will not be strong, and the pellets will not be smooth. If it is too old, the pellets will become hard and difficult to rub; the honey temperature of the medicine should be 60-80℃. The amount of honey used varies with the type of pills. The amount of honey used for honey pills is mostly 1:1 to 1:1.5, and the amount of honey for water is about 1:0.4. In addition, the ratio of refining honey to water is 1:2.5～ 3.0. In most cases, the honey pills should be packaged immediately after being formed into pills, which can ensure the moist state of the honey pills. If drying is required, microwave drying, far-infrared radiation drying and other methods are generally used. The general method can be used to prepare water pills, honeydew pills, paste pills, and concentrated pills. The pill making process is: crushing of raw and auxiliary materials→mixing→molding→forming→covering→drying→pellet selection→quality inspection→packaging. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
Moulding is the operation of forming the basic core of the pellets, and it is the key process of making pellets by the universal method. The shape of the mold directly affects the roundness of the finished product, and the size of the mold also affects the number of screenings and the size of the pellets The uniformity of specifications and content; the operation of gradually increasing the mother pellets to close to the finished product, placing the mold in the machine, adding the powder and rotating after wetting with the wetting agent; each time adding powder and wetting agent should be uniform Spread out, and the amount should be moderate.
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