Introduction to GMP standards for rotary tablet presses

The tablet machinery in the drug production process accounts for a large share of the entire production flow. In this paper, we compare the two types of vacuum cleaners of the rotary tablet press and analyze their advantages and disadvantages.

GMP (98 edition) has made special provisions for pharmaceutical production equipment. Chapter 4, Article 31 "The design, selection and installation of equipment should meet the production requirements, easy to clean, disinfect or sterilize, and facilitate production control and maintenance. , maintenance, and can prevent errors and reduce pollution"; Article 32 "The surface of equipment directly in contact with drugs should be smooth, flat, easy to clean or disinfect, corrosion-resistant, not chemically altered with drugs or adsorbed drugs. Lubricants, coolants, etc. must not cause contamination of drugs or containers."

Tablet production accounts for a considerable share of the entire pharmaceutical production process, especially tablet press equipment is the key equipment for tablet production. In order to improve the quality of medicines, Zui has to avoid all kinds of pollution in the process of drug production and reduce errors. It is necessary to carry out GMP certification for the whole process of drug production, and also put forward corresponding requirements for tablet production equipment.

Due to its high output, stable quality and suitable for scale production, the rotary tablet press has become the main equipment for tablet production and is widely used by most pharmaceutical companies. According to GMP requirements, the rotary tablet press must have a vacuum cleaner. The following discussion focuses on the causes of dust generated by rotary tablet presses, the need to increase vacuum and the comparison of common vacuum cleaners.

1. Rotary tablet press has three main procedures: filling, tableting and filming.

The granular material falls into the feeder through the hopper, and is forced to fall into the middle die hole by the self-weight of the material, and the upper punch and the lower punch rotate along the rail guide, and the material is pressed into pieces by the upper and lower pressing wheels, and then The lower punch rail guides the pressed piece out of the middle die hole and then flows into the slot.

2. The reasons for the dust generated by the rotary tablet press are as follows:

(1) Dust generated during the manual feeding process.

(2) For the ordinary feeder, the height of the feeding hopper is not properly adjusted, so that the gap between the hopper and the grid feeder is too large, and dust is also generated when feeding.

(3) For the forced feeder, the connection pipe between the feeding hopper and the forced feeder is not tightly sealed, and dust is also generated when feeding.

(4) Dust generated by the bottom of the ordinary feeder or the gap between the scraping plate and the turntable is too large to cause powder leakage.

(5) The material flow rate and the turret rotation speed do not match the dust generated by the flash phenomenon.

(6) The ram is worn due to prolonged use, resulting in excessive clearance between the ram and the die hole in the turret, and the dust generated by the phenomenon of “puffing powder” during the tableting process.

3. Rotary tablet press increases the necessity of vacuuming The dust generated by the rotary tablet press can easily cause “plugging”, damage the rail guide, generate dust in the electrical cabinet, causing electrical disconnection, and polluting the tablet chamber is not suitable for tableting. The cleaning and disinfection of the chamber, the wear of the die hole in the turntable is intensified, and the materials are wasted. Therefore, it is necessary to increase the dust suction device, recycle the materials, improve the utilization rate of the materials, and comply with GMP.

Rotary tablet press in the production process, due to the feeding device or the material itself, the dust easily falls into the middle punching plate. At the same time, the clearance between the lower punch and the lower middle plate is too large, which will make the dust fall. Into the punch, it is necessary to use a special vacuum device to remove the dust import pump Castel red wine.

4. Comparison of vacuum cleaners 4.1 External dust suction At this stage, rotary tablet presses generally use external vacuum cleaners to vacuum, mainly divided into mechanical dust collectors, wet dust collectors, electrostatic precipitators, filter dust collectors. However, a mechanical dust collector is commonly used, and its main structure is to vacuum by a vortex pump.

The working principle of the vortex air pump: the impeller of the air pump is composed of dozens of blades. It is similar to the gas turbine impeller. When the impeller of the vortex air pump rotates, the air in the middle of the impeller blade is subjected to the centrifugal force, moving toward the edge of the impeller, and The centrifugal force moves away from the edge of the impeller and enters the annular cavity of the pump body. Due to the centrifugal force and the special shape of the cavity simultaneously acting on the air, the moving air is returned to the impeller again, and the same way is started from the starting point of the blade. Cycling movement. Since the air is uniformly accelerated, the circulating airflow generated by the rotation of the impeller causes the air to escape in a spiral trajectory. The air filtered through the filter belt is discharged into the room, and a slight dust is generated in the indoor environment.

If the vortex air pump runs for a long time, the vortex motor will heat up and the pump will be easily blocked. At the same time, the powder storage barrels produced by most manufacturers are not well sealed, which makes the vacuum cleaner's vacuuming effect poor.

4.2 Built-in vacuuming Another type of built-in vacuuming, as shown in Figure 2. The fan is placed inside the tablet machine base, the power is transmitted through the main motor, the suction port is connected to the suction nozzle, and the suction port at the top of the tableting chamber sucks in the air first through the cyclone separation device, and then through the filter element to filter the air discharged from the base. The inner annular duct flows into the tableting chamber, thus forming an internal dust removal system for the rotary tablet press.

The cyclone separator of the device has the advantages of simple structure, small occupied area, convenient operation and maintenance, small pressure loss and low power consumption, and is suitable for high temperature, high pressure and corrosive gas, and the motor temperature rise is low even if the running time is too long. Does not reduce the vacuum effect.

5 Conclusion Through the comparison of the above vacuum cleaners, the author personally thinks that the rotary tablet press Zui chooses built-in vacuum to achieve good vacuuming effect.

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