A Wet Granulation Line is a highly efficient equipment used in the production of pharmaceutical products. Its benefits include reduced dust pollution, uniformity of drug substance in the final dosage form, and ease of regulation. Additionally, this equipment features a dust collection bag and components made of food-grade chrome-plated steel. It also features easy internal temperature adjustment.
Wet Granulation Line Reduces Dust Pollution
Wet granulation can reduce dust pollution during manufacturing processes. It reduces air entrapment, reduces variations in batch size, and increases compressibility of powder. While wet granulation is not suitable for all powders, it can be effective for some types.
In-line measurement of bulk powder properties has shown considerable value in optimizing wet granulation processes. This technology can provide real-time information to monitor critical processes and improve process efficiency. It also improves the quality of the finished product. This technology can be used to monitor tableting blends, granules, or tablets.
The size of grain particles is an important parameter that determines granulate activity. The researchers looked into the factors that influence grain particle size and determined how to control them. The most important technological variables were temperature and the internal diameter of the nozzle used for the feeding of the melt.
The size of the primary granule also plays an important role in determining its quality. A small percentage of the powder may be glassy, while a large quantity may be amorphous. The amount of glassy phase in granules depends on the degree of grain size, the amount of external porosity, and the amount of structure.
Wet Granulation Line Improves Uniformity of Drug Substance in Final Dosage Form
To improve uniformity of drug substance content in final dosage forms, manufacturers must carefully select the appropriate manufacturing processes. The appropriate processes can include wet granulation or roller compaction-based dry granulation. Both of these processes add an additional mixing step that alters the particle size of the drug and the excipients. The choice of loading method for the drug is also important to ensure uniform distribution.
One of the major challenges in developing a low-dose solid dosage form is the need to ensure that the drug substance is uniformly distributed across the powder blend. This process can be challenging, particularly when the drug substance is poorly flowing or has a wide range of particle size. In order to achieve uniform distribution, the drug substance must be co-micronized with excipients of similar particle size. To accomplish this, the process can include sieving through a small opening to facilitate BU.
Wet Granulation Line Reduces Dust During Manufacturing Process
The pharmaceutical wet granulation process transforms the properties of a powder blend, with the goal of generating an optimized feed for further processing. The process is flexible, efficient, and reproducible, and is ideal for many pharmaceutical applications. Its short processing time and precise dispersion yield dense, uniform granules that are ready for tableting. It is an integral step in many oral solid dosage manufacturing processes.
This process involves several stages, including granulation, blending, and drying. This often results in significant manual labour and a potentially hazardous environment. Integrated granulation systems simplify the process and make it safer for workers. Closed-loop operation eliminates the exposure of operators to toxic dust and vapour. In addition, closed-loop processes are more efficient and reliable.
The first step of wet granulation involves the introduction of lubricant into the powder mixture. This lubricant helps the granules flow more easily. The quantity of lubricant depends on the formulation scientist, but it ranges from 0.1% to 5% of the final product weight. It can be in the form of calcium stearate, magnesium stearate, or stearic acid.
Improves Product Quality with Wet Granulation Line
High shear wet granulation (HSWG) is a complex process with many variables that affect product quality. It is critical to understand and control these variables for optimized product development. In this article, we will explore the principles and best practices for HSWG-based product development and demonstrate how to apply quality-by-design concepts.
Using a DFF sensor to measure wet mass concentration, flow resistance, and particle interaction is a powerful technique to control wet granulation processes. This method can be used for formulating, process development, and routine monitoring. In addition to its accuracy, DIA can provide information on particle size and shape.
Another key benefit of a wet granulation line is the integrated granulation train. This design helps ensure the containment of dust and vapour during the transfer of product from one area to another, which is critical for processes involving organic solvents or moisture-sensitive products. Additionally, the closed-container design prevents the potential for product contamination. This helps to ensure the safety of operating personnel.