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In addition, a heated pipeline protects the product from solidification. However, in the manufacture of suppositories on lipophilic bases (usually plastic film is used to form them), which have a more liquid consistency and a low melting point (32–37 ° C), a peristaltic pump is used.
This is because the active substances introduced into the base in the form of a powder fraction can settle in an unheated pipeline or tank when the machine stops and during the slow passage of the product through the pipeline. Using a peristaltic pump allows you to maintain the required temperature of the product, eliminates its stagnation in the pipeline and the sedimentation of active substances, ensuring uniformity of the consistency of the suppository mass. The cells are filled by inserting a filling needle into the hole of the cell through which the liquid suppository mass enters. All process data is displayed on the touch screen, which also sets the volume of filling cells. After filling the cells, the suppository tape enters the cooling unit. The cooling process of the product can proceed in two or four stages, depending on the solidification time of the components that make up the suppository mass. Two-stage cooling uses two sequentially installed cooling spiral chambers, and four-stage cooling uses four chambers. The two-stage cooling time is 9 minutes, the four-stage cooling - 18 minutes. Thanks to the spiral paths, the suppositories are cooled on both sides by a controlled flow of air with temperature until the product solidifies completely, thus obtaining the optimal shape.
Cooled contour cells enter the sealing unit. First, the suppository tape is preheated, after which the top of the contour cells is sealed. Using the preheating stage, as in the molding unit, provides high-quality and reliable sealing of the package.
After the cells are sealed, a code or date is applied, perforated to easily separate the cells and cut off the upper edge of the tape. Suppositories can exit the SAAS 9-AR machine in the form of a tape (if docking with the cartoning machine is through a special docking module) or in the form of chopped blisters. The number of suppositories in the blister is set from the control panel of the machine.
Therefore, the use of the UR-4 machine at the cooling stage can significantly reduce the solidification time of the product, as well as make the process manageable and controllable. When the suppository mass in the cooling installation has completely hardened, the finished product reel is transferred to the BP-11 automatic machine for sealing containers and cutting the tape. In the BP-11 machine, the tape is sealed and cut into segments with a given number of cells. Sealing is carried out by pulsed heating and compression. The stable temperature of the sealing tool is provided by two high-power fans. Simultaneously with the sealing, an encoding operation is performed. The coding of containers (applying the series and date) is carried out by extrusion by means of a cliche. After sealing, the edges of the tape are automatically processed. This operation can significantly improve the appearance of the finished product. To control the process of cutting the tape into strips of a given length, a digital programmer is used, which sets the cutting range from 1 to 10 suppositories. In the market of pharmaceutical equipment for the production of suppositories, the Italian company Sarong is well known, which produces equipment for both small manufactures and for enterprises with high power. Sarong manufactures automatic machines for the production of suppositories of the SAAS series of four modifications: SAAS 2-АР, SAAS 6-АР, SAAS 9-АР and SAAS 15-АР with a capacity of 5 thousand to 30 thousand suppositories per hour. These machines allow the production of suppositories in blister packs of aluminum and thermoformed plastic. Unlike production with medium power, in industrial machines of high productivity, the contour cells are molded directly in the machine. As an example, consider the automatic machine SAAS 9-AP. This is a high-precision machine with low noise and high performance (up to 22 thousand suppositories per hour). Machine control is carried out through a programmable logic controller (PLC). The automatic machine has an optimal operating mode, which avoids the formation of waste during the production process. Consider the principle of operation of the automatic machine SAAS 9-АР. The suppository production process begins with the formation of blister strip packaging from plastic film or aluminum foil. Two rolls of plastic film (one roll with print, from which the front part of the suppository package is formed, the second roll without print) are installed; on roll holders. Plastic films from both rolls simultaneously enter the preheating unit, where they quickly heat up to the desired temperature. In this case, the required film tension is regulated by a special device. Pre-heated plastic films enter the film heat sealing unit in the shape of a contour cell.
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Thus, two films are connected to each other over the entire surface, with the exception of the inner space of the cells. Then the film enters the molding unit, where when blowing compressed air into the unsoldered space, volumetric molding of the contour cell occurs. At the same time, a small hole remains open in the upper part of each cell, through which the cell subsequently fills with a suppository mass. In the case of packaging made of aluminum foil in the block for forming contour cells, the assemblies intended for working with plastic film are dismantled - the pre-heating film unit, the film heat-sealing unit, and the forming unit. In their place, an aluminum foil cell forming unit is installed. Due to the heavy weight, the installation of this unit in the machine is carried out using a lifting mechanism. It should be noted that the devices are common to both types of packaging. Two rolls of aluminum foil are installed on the roll holders (one with print, the other without printing). The foil tension is adjusted by the device. The aluminum foil tapes from both rolls simultaneously enter the forming unit of the contour cells, where the cell contour is mechanically extruded onto the surface of the aluminum tape. Thus, unlike a plastic film, forming of cells from aluminum foil does not require preliminary heating and the use of compressed air. Two ribbons with not formed interconnected halves of the contour cells come out of the molding unit. Then both tapes are connected together so that half of the cells coincide completely, and enter the site, where the tapes are heated and finally connected by heat sealing. At the same time, as in the case of plastic film, at the top of each cell, an opening for entering the suppository mass remains open. Thus, a contour cell molded from a plastic film or aluminum foil simultaneously serves as an injection mold. Molded from plastic or aluminum, the packaging in the form of a tape enters the filling unit. The suppository mass, heated to a temperature of 30-80 ° C, depending on the active substance and the base included in it, flows from the reservoir through a pipeline to a volumetric dispenser, from where the product is automatically loaded into the cells.
To maintain the required temperature and uniform consistency of the suppository mass, the 80-liter tank is equipped with a water jacket and a stirrer. In the production of glycerin-based suppositories with a viscous consistency (they are usually formed into aluminum foil), the mixer provides uniform mixing of the suppository mass, heated to a temperature of about 80 ° C.