Various compounds with new therapeutic functions have been discovered in modern society, and their toxicity is increasing. Some of the special drugs have high activity or toxicity characteristics. Pharmaceutical companies have to face the problem of how to better protect operators during the production process of solid preparations.
The sealing in the production of solid preparations refers to the effective isolation and sealing of harmful substances during the production process through a of technologies and measures, in order to protect the safety of products, personnel, and the environment. This concept is particularly important in drug production, especially for the production of highly active drugs. Sealed technology can effectively control pollution and ensure the quality and safety of drugs.
The Dr.Pharm LGS-120-HC High containment roller compactor is an addition of an isolation cover on the basis of the original roller compactor to ensure that material processing and processing operations are completed in a Containment system, to isolate external environmental pollution of drugs and prevent drugs from causing harm to operators, providing better protection for operators.
The main framework is equipped with drive units for various functional components, hydraulic systems, vacuum systems, fans, pneumatic component mounting plates, water gun pipelines, and pipelines for machine cooling. There are 5 maintenance doors installed on the main frame, which can be used to repair the internal components of the equipment. An exhaust fan is installed on the doors for heat dissipation, and the internal pressure is slightly positive to prevent dust from entering. All components involved in production (feeding system, roller assembly, crushing system, granulation system, casing assembly, rotation protection, isolation cover) are fixed at the front of the rack. Ensure the separation of the transmission area and production operation area during the production process. The internal structure is divided into upper and lower layers, and the upper layer can be disassembled as a whole for easy maintenance. An inflatable seal is used between the isolation cover and the front panel of the main frame. Install 4 feet at the bottom of the main frame.
The partition inside the feeding hopper divides it into an exhaust chamber and a material chamber. The material passes through the material chamber and is stirred by the stirring blade and sent to the pressure wheel by the feeding screw. The air trapped during the material falling process can be discharged through the exhaust chamber. During the material conveying process by the feeding screw, the material is pre-compressed and degassed. The air generated during the material extrusion process is discharged through the degassing filter element. The speed of the stirring blade and feeding screw can be adjusted within a certain range. The spiral speed determines the output, which directly affects the extrusion capacity of the dry granulation machine.
Two pressure wheels are arranged vertically up and down, and the surface of the pressure wheel usually has grooves or mesh patterns, in order to increase the friction force on the surface of the pressure wheel, improve the driving force of the material, and increase the amount of material in the narrow slit between the two pressure wheels. There are two sealing plates on both sides of the pressure wheel to seal it. During the pressing process, the lower pressure wheel is fixed, and the upper pressure wheel moves up and down according to the different feeding amounts. The hydraulic system provides hydraulic pressure applied to the upper pressure wheel, which regulates the pressure of the material by adjusting the magnitude of the hydraulic pressure, thereby controlling the extrusion effect. The cooling water is supplied to the inside of the pressure wheel through the main shaft to prevent the material from deteriorating due to the heat generated during extrusion. The speed of the pressure wheel can be adjusted within a certain range.
On the right side of the pressure wheel, there are upper and lower scraper blocks, and the gap between the scraper block and the pressure wheel is adjustable, which can timely scrape off the material stuck to the pressure wheel. The material crushing area can crush the large pieces pressed out by the pressure wheel into small pieces. The pressure wheel and crusher are arranged inside the casing, and the casing has position detection. If not installed properly, an alarm will be generated, and the equipment cannot operate normally. Cleaning pipelines are arranged outside the casing, and high-pressure cleaning nozzles are installed near the pressure wheel. A cleaning ball is installed at the top for online cleaning, and a respirator is installed on the right side of the top of the casing.
After being pressed into sheets, the material is initially crushed by a crusher and then enters the coarse particle area. It then enters the fine particle area below, where the particle size is determined by a sieve with an appropriate mesh size.
The whole granule system is located under the sealing cover. Removing the cover allows for maintenance and repair of the entire wheel and sieve. There is a sampler on the casing, which can be used to sample and observe the product at any time.
The whole wheel is driven by a reducer, and the rotational speed of both whole wheels can be adjusted through a frequency converter. If you only want to use one whole granule, use the fine granule unit below, and the coarse granule unit above only comes with a sieve basket, without the need for a sieve. In addition, the gap between the whole wheel and the U-shaped screen can be adjusted by adjusting the gap nut.
The squeezing force on the pressure wheel is provided by the hydraulic system. The hydraulic pressure can be adjusted within the limit. There are two double acting hydraulic cylinders at the front end to provide pressure for the upper pressure wheel, and two hydraulic cylinders at the rear end to balance the pressure. The two diaphragm type accumulators in the hydraulic system act as elastic buffers to ensure constant pressure during the production process.
The isolation cover is a single-layer top and double-layer other parts, with internal corner arcs of R30 and no dead corners. There is a drainage outlet at the bottom of the right side, which is controlled by a pneumatic valve. The bottom layer has a tilt angle for easy drainage.
The front department installs frames for aluminum alloy glass, 10mm thick tempered glass, locking handles, inflatable seals, and proximity switches. Five 10 inch sterile operating gloves with vertical oval openings for easy operation. Configure compressed air gun and cleaning water gun, and weld hooks with guns. There is a continuous bag on the left side for the entry and exit of tools or other items during operation.
Exhaust fan with a power of 0.7kW, featuring a cylindrical filter PUSH-PUSH structure at the exhaust outlet for easy installation and replacement. High efficiency filter elements are installed at the exhaust and intake ports, and pneumatic valves are installed on the intake and exhaust pipelines.
Configure LED spotlight with 20W and 24V. Configure sensors to detect the temperature and humidity inside the chamber, as well as sensors to detect the pressure difference inside the chamber. A pressure gauge is used to measure the exhaust pressure difference. Both the inlet and outlet are connected by soft connections. The AB valve is used for feeding and discharging, and there is a cleaning water pipe at the top for online cleaning of the equipment. The connection between the isolation cover and the main frame is sealed with inflation.
A cooling system is installed to cool down the pressure wheel during the pressing process. Cold water is connected to the main shaft through a rotary joint and enters the interior of the pressure wheel, taking away the heat generated by the pressure wheel. It then enters the chiller, which has a cooling power of 2P and a water pump power of 0.75kW. The self-priming pump operates under negative pressure circulation. The chiller is equipped with a water suction function, which can suck all the cooling water inside the equipment back into the chiller water tank after granulation is completed. Pipeline configuration return water temperature detection.
A sealing damage detection system with patented technology (patent number: ZL 2019 2 2066360.2), in which compressed air is introduced between the two seals. When the seals are damaged, the compressed air leaks out, and the system alarms but does not stop, but the equipment can still be used normally. The tested parts include feeding mixing, feeding screw, upper pressure wheel, lower pressure wheel, crushing knife, coarse and fine granules.
