Introduction to ultra-clean granulation production line

In order for multifunction devices to operate efficiently, attention must be paid to automated hygiene. In this regard, the examples presented in this article can give you some inspiration - with the newly designed metal filter device, it can significantly shorten the hygienic cleaning time of pharmaceutical production equipment. “The production equipment for pharmaceutical products used in multi-species production often has a long downtime due to the frequent conversion of different types of drugs. Therefore, we have given high priority to the optimization of the sanitary cleaning time of pharmaceutical production equipment.” Swiss Mepha Non-patent Drugs Daniel Leuthardt, head of the production and quality department at the production plant, said in introducing the new granulation line.

The granulation line developed and manufactured by Oystar Hüttlin consists of two parts: the HTG800 HighShear mixer and the HFGC200 fluidized bed. The loading and unloading of the production line adopts a pneumatic control system, and the pneumatic system is used for transportation and transportation between the stations, so that the entire production line has a low height and can complete the installation of all the production lines in the height space of one floor. As a truly versatile production line, all compressed air systems in the complete unit operate at 10 bar. Therefore, it is also suitable for the production of products with small energy sources less than 3MJ.

In order to be able to complete as many different production processes as possible, this equipment has the ability to granulate and dry directly in a fluidized bed. To this end, a fluidized bed is integrated with a bottom injection system to make the fluidized bed particles more granular and efficient. Since the fluidized bed also undertakes the task of coating sugar tablets and tiny tablets, the device plays a "all-rounder" role before and after the tablet production.

Compact wet granulator

Mischorgan Gentlewing has developed a very compact and sturdy granulation equipment with very good raw material handling properties. The main conveying pusher moving along the wall of the cylindrical container can not only transport the mixed effective pharmaceutical ingredients and auxiliary ingredients; but also can transport the manufactured medicine particles up to the middle, ensuring that the mixer has no dead ends when working, raw materials Mixing time and work cycle time are relatively short. The mixed raw materials have a small amount of wall hanging on the wall of the container. The high and high rise to the discharge plate of the mixer cover can also avoid the phenomenon of wall hanging, ensuring the automation of the production process without manual intervention. In the mixer, true granulation is carried out between the main push plate and the vessel wall. A portion of the fine particles are conveyed through the space between the main push plate and the container wall by a specially designed mixing plate structure and compacted. A portion of the input energy is used directly for granulation, rather than using rotation. Therefore, it is also capable of granulating drugs that are very sensitive to temperature changes. The special emptying valve can be used to transport the intermediate products into the pneumatic conveying pipeline through the wet abrasive machine, thereby realizing the emptying of the production equipment. The mixing mechanism relies on the permeable nature of its container walls and a specially designed bottom mechanism to ensure minimal residual emptying of the residue.

Central nozzle cleaning device of FIG. 2 may be rotated <br> <br> uniform particle size in the range of 360 °

The key core components of the two equipments at the Mepha generics manufacturing facility, and the key component of the HDGC200 fluidized bed, are the specially designed, patented bottom injection unit, the Diskjet gas manifold. It allows the solids of the drug to be sprayed along with the gas. Since the gas manifold has the ability to form a swirling airflow through the passing airflow, a good mixing effect and a uniform jetting effect are ensured. Depending on the humidity of the gas, the solid pharmaceutical ingredient can be dried, heated, humidified, cooled, or agglomerated by the addition of a binder and coated with a coating material for sugar coating. These directional flow streams have a short homogenization time prior to injection, thereby ensuring uniform drying time for each particle. Combined with the nozzle installed at the bottom, the jetted airflow has a good flow state. The flat bottom plane, the narrow slit that slopes toward the working chamber, avoids the accumulation of raw materials in the medical product, and is also very easy to clean. If the accumulation of drug particles occurs, or if the drug particles are caught in the narrow slit during the hygienic cleaning process, the structural form of the slit inclination can also effectively prevent the drug particles from being stuck in the gap. The structural design and sanitary cleaning optimized components in accordance with the GMP pharmaceutical production management technical specifications make the sanitary cleaning work of the granulation production line more favorable and shorten the time required for sanitary cleaning.

Avoid cross contamination

Non-patented drug manufacturers such as Mepha use different production processes for the production of different varieties of generic drugs. Therefore, the sanitary cleaning of pharmaceutical production equipment needs to be at a high level to avoid cross-contamination. The point of the new ultra-clean sanitary cleaning solution is that the fully automatic cleaning time of the complete set of equipment is reduced. The CIP in-situ cleaning of the complete set often encounters the metal filter screen, which collects a lot of residual medicine on the side of the clean room of the filter. At the same time, the metal filter also increases the difficulty of emptying the cleaning liquid. This has led to the use of rather cumbersome cleaning techniques and long-term production shutdowns of production equipment.

Oystar has developed and developed a new type of metal filter that can be opened during the hygienic cleaning of pharmaceutical production equipment, thus solving the above problems. The inside of the filter element has an inner cone shape. The filter element can be pulled down by a pull rod to open the filter, so that the solid raw material on the side of the clean room can be quickly and conveniently discharged. This technical improvement significantly reduces the hygienic cleaning time of the production equipment and ensures a high quality hygienic cleaning effect.

The center of the fluidized bed coating unit has a retractable cleaning nozzle that makes the ultra clean cleaning system perfect. This retractable cleaning nozzle is capable of 360° rotation in three different extended positions, ensuring a more thorough cleaning of the production equipment. The computer-assisted support of the sprinkler opening size combined with the excellent sprinkler speed of the Zui achieves the design of the Zui good that meets the equipment cleaning needs.

The HighShear mixer is also equipped with this cleaning nozzle, which plays a decisive role in the cleaning of the control valve, the cleaning of the pipe, the cleaning of the mixing device and the cleaning of the emptying device. In this hygienic cleaning process, the precise working position of the nozzle plays a decisive role in the cleaning effect, and the manual intervention is also reduced to a low degree. The hygienic cleaning solution with the exact performance and actual needs guarantees the hygienic cleaning of the whole set of equipment in a short time. The effectiveness of this system has been confirmed by the success of hygienic cleaning.

Tailored equipment

Very short drug production time and sanitary cleaning time, high equipment availability, fast feeding and quick emptying, modern safety protection technology, environmental protection, simple operation and high degree of automation, is the choice of Mepha An important reason for this Oystar granulation line.

The line was designed and built to exacting requirements and aspirations, and it took only eight months to put into production, as the system has been tested in Oystar's own technology center. In this granulation production line, they only slightly adjusted the standard sanitary cleaning program, and took it out as a variant configuration to ensure the reliability of the user's investment and ensure that the equipment is put into production at a fast speed.

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