Грануляторы в фармацевтической промышленности – всесторонний обзор

Pharmaceutical manufacturing is a complex industry. If you are planning to get into the world of pharmaceuticals manufacturing, you will have to deal with many complex machineries. Granulators are a perfect example for them.

The role of a granulator is to transform powder or fine particulate materials into uniform and free-flowing granules. This process is essential for creating pharmaceutical products with consistent quality. They will also offer better processability and optimal drug delivery. Read on and let’s learn more about granulators in detail.

What is a Granulator?

A granulator is a special equipment used in pharmaceutical, chemical, and other industries. It can convert powdered or fine materials into granules. In other words, this indispensable tool can transform raw materials into a form that is easier to handle. Hence, granulators play a major role behind manufacturing drug products.

What is Granulation in Pharmaceuticals?

Granulation is the technique that converts fine particles into granules. In other words, it converts the powder-like particles to a more stable structure. This transformation is not just a mechanical process. It can enhance the quality, stability, and performance of pharmaceutical formulations.

What is the Purpose of a Granulator?

There are numerous reasons to use a granulator in the pharmaceutical industry. Here are the main reasons:

• Improving Flowability

Granulators are capable of converting fine and cohesive powders into free-flowing granules. These granules are easy to handle and process in the manufacturing stages. The pharmaceutical manufacturers can easily process granules during tableting and capsule filling.

• Improving Compressibility

Granules come with better compressibility than fine powders. It is important when creating uniform and robust tablets with consistent drug content. It helps the pharmaceutical companies to enhance quality of their drugs.

• Uniform Drug Distribution

The granulation process can ensure more uniform distribution of Active Pharmaceutical Ingredients (APIs). This can help with ensuring consistent drug dosage at all times.

• Reducing Dust

The process of converting fine powders into large granules can minimize dust generation. This can eventually enhance workplace safety. Moreover, it can assist to reduce product loss as well.

• Controlling Release

It is possible to use specific granulation techniques to control drug release formulations as well. It helps the pharmaceutical manufacturers to make drugs according to the recommendations.

What is the Process of Granulation in Pharmaceutical Industry?

Before buying a granulator, it is important to be aware of how the granulation process looks like. Here’s an overview of the entire process.

Step 1 – Preparation of Raw Materials

The first step is to thoroughly analyze all the physical and chemical properties of raw materials. This helps with ensuring that all ingredients meet quality and purity specifications. Moreover, it involves evaluating the initial particle size distribution of powders as well. On top of that, this process may involve measuring and controlling moisture levels of the ingredients.

Step 2 – Mixing and Blending

The second step is to combine all dry ingredients. This includes pharmaceutical ingredients as well as excipients. During the mixing process, it is important to ensure uniform distribution of all components. The pharmaceutical manufacturers can use V-blenders, planetary mixers, and high-shear mixers for mixing.

At the time of mixing ingredients, it is also important to ensure time optimization. It will help them to end up with the perfect blend.

Step 3 – Granulation

Wet Granulation Method

This is the most common process. It starts off with binder preparation, which involves creating the liquid binder solution. Then the manufacturers gradually add binding solution to the powder mixture. It will help with creating the initial granule clusters through mechanical mixing. Moisture control is essential throughout this process. It will ensure proper formulation of granules.

Dry Granulation Method

Dry granulation method starts with applying high pressure to compress powder mixture. Then the manufacturers will create solid masses or ribbons. After that, they will break the compressed masses into granules. Screening process will ensure uniform granule size at the end of the process.

Step 4 – Drying

This process involves removing excessive moisture from granules. There are three main drying techniques that pharmaceutical manufacturers follow. They include:

• Fluid bed drying
• Tray drying
• Vacuum drying

Throughout the drying process, it is essential to maintain precise temperature. It can prevent material degradation. During this process, it is also important to ensure that final moisture level meets specifications.

Step 5 – Sizing and Screening

Size reduction process will break down larger pieces of granules into uniform size. Then the manufacturers will use mechanical screens or mills for screening. The next step is to ensure size classification. This is where they separate granules into desired particles with appropriate size ranges. Then it is possible to eliminate dust and other oversized granules.

Step 6 – Lubrication

The next step is to incorporate appropriate lubricating agents. Along with that, uniform coating is also essential. To prevent sticking, the manufacturers will reduce friction during the subsequent processing steps. Moreover, they will enhance granule movement and compressibility as well.

Step 7 – Quality Control

During quality control, physical testing and chemical analysis will happen. Physical testing is all about evaluating the granule properties. It includes particle size, bulk density, and moisture content. On the other hand, chemical analysis will confirm the uniformity of active ingredients.

Шаг 8 – Упаковка и хранение

It is important to use appropriate containers for packaging. Moisture barrier packaging plays a major role here. After packaging, the granules require proper storage under specified conditions.

5 Common types of Pharmaceutical Granulators

There are many different types of granulators available for purchase. It is important for you to make the right selection when getting a one. Here are 5 of the most common types of granulators available:

Oscillating Granulators

These granulators come with an oscillating rotor. It moves back and forth during the granulation process. Powder will need to pass through the mesh or screen that swings to create particles of desired size. The size of granules will vary based on the size of holes available on the screen. It is possible for you to adjust this size to the screen according to your needs. Moreover, you can also adjust the rotating speed as per your material properties.

You can use an oscillating granulator to process:

• Moisture sensitive powders
• Food additives

Roller Compactor Granulator

These machines follow dry granulation technique. You can use it to convert powders to granulators without using any liquids. Inside the granulator, you will see two different counter-rotating rolls. After pouring the powder, it will compress between two ribbon sheets. Then it will break down the compact sheet into granules.

You can use a roller compactor granulator to process:

• Moisture sensitive powders
• Heat sensitive powders

High Shear Granulator

These are high-speed granulators available. In other words, these granulators can mix powders at a high speed when forming granules. As a result, you can experience a higher level of efficiency out of them. Moreover, intense mechanical forces in these granulators ensure thorough mixing. You can ensure consistency in both density and size of these granulators.

Vibrating Granulator

Vibrating Granulators are ideal for completing the granulating process. They are quite similar to granulators with oscillating function. However, they don’t rotate the particles to break them down. Instead, it happens through a vibration process. It ensures precise break down of granules to desired sizes.

A vibrating granulator is ideal for:

• Heat sensitive powders
• Moisture sensitive powders

Гранулятор с псевдоожиженным слоем

А Гранулятор с псевдоожиженным слоем will suspend processing powders through a steam of air flowing upward. Then it will create a fluid state. This is a stage where particles would behave similar to a fluid. As a result, you can ensure even distribution of moisture and heat. Then the binder solution gets into the fluids and sticks together to create granules.

How to Choose a Great Granulator?

How can you pick the best granulator out there to serve your purpose? Keep the following tips in mind for that:

• Production needs

Understand what pharmaceutical products you need to produce before buying the granulator. For example, you should get a sheet granulator for producing tablet granules. The granulator you get should be in a position to handle all your input and output sizes as well.

• Operational factors

Pay attention to ease of maintenance, noise level, and power consumption of the granulator as well. This will help you with running the granulator efficiently.

• Material properties

You should buy the right granulator based on the materials that you are working with. This is where you should focus on hardness, fluidity, moisture content, and brittleness of the materials that you work with. For example, if the materials are sensitive to humidity, you should get a dry granulator.

Get a Top-Quality Granulator with Grand Pack

Now you have a clear idea of what granulators are all about. By following the tips we shared, you can proceed with getting the right granulator. However, you need to buy it from a place that you can trust. That’s where Гранд Пак can help you with. Feel free to browse the granulators we have at Grand Pack and get yours. If you have any questions, always feel free to get in touch with the team.