Ketuo Modul Tablet Press

The latest Modul tablet press from Kotuo is a modular machine. All parts of the machine that touch the product are mounted on a replaceable ECM. This allows the equipment to be retrofitted more quickly and with an operator exposure level (OEL). ) As low as 1 mg/m3. After processing a batch of products, the operator simply disconnects the ECM and replaces it with a clean part. The used ECM is entered into a remote cleaning station while production continues. According to the relevant person in charge of the company, the entire operation process did not exceed 30 minutes.

The standard Modul tablet press has a tightness rating of 10 mg/m 3 , and now it has introduced two higher-grade ECM machines – a high-seal ECM and a high-seal ECM with cleaning capabilities. Operator exposure levels for these two models can be as low as 1 mg/m3.

Kotuo said that this unparalleled degree of containment is suitable for the safe processing of drugs such as hormones or anti-cancer drugs, and does not require operators to wear tight work clothes. Independent ECM in the machine also eliminates the need to use a dust cover, improves visibility, and is easy to maintain. It can minimize the use of costly clean room space.

30 minutes to complete equipment modification

Kotuo stressed that this device requires only 30 minutes of adjustment, and traditional tablet machines require 8 hours. Rapid equipment modification makes it more economical to process small batches of high-value or toxic powder products. Some drugs may be compressed into tablets for the first time.

The company also invented a very simple, simultaneous, continuous control of weight and stiffness for a standard tablet press that can improve product quality. The two control systems work in separate two compression zones, the weight control is performed in the pre-pressure stage, and the hardness control is performed in the main compression stage. Now this device is in Modul
Choose from four versatile controls on the tablet press. This device is based on the weight control principle of the company's existing tablet press, rather than controlling the weight by measuring the pressure at the main press station. The person in charge of the company said that the reason for doing so is because the pressure measurement at a fixed thickness is very limited in accuracy and effectiveness, and is subject to different models. In fact, there is no linear relationship between weight and pressure at a fixed thickness, and this relationship must be determined empirically. At the same time, it is also affected by the rigidity and temperature of the machine.

Therefore, as early as the 1970s, the company decided to use a different principle to control the weight of tablets on a rotary tablet press. The basis of this principle is to measure the change in thickness at a fixed pressure, rather than the change in pressure at a fixed thickness, and the measurement is performed at the pre-press station rather than at the main press station. Kotuo explained that the most important feature of this principle is the linear relationship between the measured thickness and the weight being controlled.

In the pre-compression stage, when the powder block is subjected to a uniform pressure, its thickness is linearly proportional to the weight, and the thickness tolerance tolerance can be directly established as a weight tolerance function, thereby reducing the approximation error and improving the control accuracy. Because tolerance tolerances are automatically calculated by the control system, the validity of parameters and data is easier to establish.

In addition, the relationship between tablet thickness and weight in preloading is said to be independent of machine stiffness. Therefore, transmission between machines does not affect the drug, and the effect of machine temperature is negligible, thus avoiding production. The weight change that occurs as the machine heats up at the beginning of the process.

Another important advantage of the device is said to be that during the pre-compression phase rather than the main compression phase, the master control system is recalibrated by changing the height control pressure without affecting the final thickness or weight of the tablet. Because the company's weight control system needs to measure thickness changes, the main compression station will not participate in weight control, so the main compression height is set to the correct tablet thickness from the beginning and remains constant throughout the production process.

Balanced thickness

This may be referred to as "a constant thickness tablet", and the main compression pressure and tablet hardness may vary due to the characteristics of the powder. If the tablet hardness exceeds the tolerance, it will be detected by manual or automatic on-line sampling analysis and stop the tableting. It is also possible to enter the "thickness constant tablet" mode by turning on the secondary main control system: the pressure sensor at the final compression station measures each of the different main compression pressures and calculates a moving average. This moving average signal is used to adjust the main compression. Height to ensure that this number is within preset limits. In this way, an additional control program, the so-called "hardness control program" will correct the thickness of the tablet to keep the main compression pressure and tablet thickness stable.

Any change in thickness must, of course, be within the pre-set thickness tolerance range. If the thickness limit is to be exceeded in order to maintain the pressure within its own tolerance, the alarm and shutdown signals will be activated. The person in charge of Cortor pointed out: "In fact, this situation means that the characteristics of the powder have changed so dramatically in the production process that it is impossible to put the three related tablet parameters - weight, hardness and thickness - Keep within preset tolerances. Production should be stopped at this time and powder characteristics and product quality need to be re-examined." Only after the manual or automatic sampling analysis can the control program be readjusted by changing the main compression force setting. . When the hardness control system is turned off, the machine enters a constant thickness mode, and each compression force and its average value can still be displayed on the control panel, and then the stop function is started. This function can stop the tablet press when the average compressive force exceeds the limit. .

The company said that all of this means that the weight control system and subsequent hardness control systems are irrelevant because they measure the process variables in different stages of compression, based on different compression parameters. Because the two processes are separate and ongoing, the control of weight and hardness is also independent, continuous, and simultaneous. This mode improves tablet quality and stability.