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Granulation

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Active pharmaceutical ingredients (API)

When you consider shifting pharmaceutical mixing processes from batch to continuous, accurate in-line continuous blending can be a real challenge.


<h2>In-line continuous blender with fast reactivity and minimum residue</h2>
The Modulomix from Hosokawa Micron is a continuous modular mixer and it has been designed to be compact with fast reactivity, minimum residue and rapid start-up and shutdown protocols, very useful in pharmaceutical applications.

It is a very compact blender because you will be able to combine the Modulomix modular mixer with PTS, LIW feeders, continuous blenders, PAT technologies and even downstream processing, like (wet) granulation and/or compact. It is adaptable due to it lets you have two different mixing environments in one single phase, multiple Modulomix mixers can be cascaded in series.

In-line continuous blender

Pharmaceutical granulators are often used with active substance mixtures to be processed into granulates, a process also known as compaction.


<h2>Dry granulation of pharmaceutical powders</h2>
With the Pharmapaktor® Serie (Pharmapaktors series L, K, and C 250) from Hosokawa Alpine, active substance mixtures are processed into granulate.

For this, the powder is first pressed into flakes/pellets. These are often crushed with a Flake Crusher into granulate.

Compaction (dry granulation) is understood to be the compression of powder between two synchronized, counter-rotating rollers. The powder is fed to the counter-rotating rollers in a regulated manner. Here, adhesive forces between the product particles are created under high pressure between the rollers.

For capsule or sachet filling the granulate must be de-dusted in a screening machine. The sieved fines can then be directly fed to the Pharmapaktor again

Pharmaceutical granulator

Fluid bed drying is a pharmaceutical process carried out to reduce the humidity and achieve the required moisture content in the granules or powders. It also applies binders or granulation liquid to facilitate the agglomeration of wet mass before further processing. When drying pharmaceutical granules, it is essential to avoid over-drying as this could result in significant wearing down, leading to product loss. To prevent losses and poor product quality, you need a fluid bed dryer to handle continuous operation.
<h2>An efficient, robust solution to dry pharmaceutical compounds</h2>
The Fluidized Bed Dryer from Romaco Tecpharm uses the drying process to reduce the moisture content in the granules. It can be configured as a dryer, granulator, and coater. It can thus dry wet granulate, top drive granulation, and bottom spray coating. It has a capacity from 30 L to 1,540 L, with other dimensions being available on request.

The fluid bed dryer for pharmaceutical solid dosage form is constructed with an in-wall design concept. It is equipped with a side-valve for automatic loading from the high shear mixer granulator. For the drying process, hot air is passed through a vacuum generated inside the machine. The wet solids rise from the bottom and are suspended in a current of air, remaining in a fluid state. The heat transfer and the low moisture content of the air in direct contact with the wet granule allow the evaporation of the water or solvents, reducing their humidity.

The equipment has a top spray that helps in carrying out the granulation. Next, the movement of the powder in a fluidized state is combined with the spraying of a binder solution. This combination allows increasing the particle sizing, generating a granulate. Finally, the coating process is carried out by combining the spraying of the coating suspension on the micro granules in a fluid bed movement.

Fluid bed dryer for pharmaceutical solid dosage form

It is rather difficult to successfully produce a pharmaceutical solid dosage forms with the desired properties such as size, morphology, hardness and friability. You need a solution that can transform fine heterogeneous powders into homogeneous blend of granules with bigger size and higher density in a short time and with repeatability. Wet granulation is carried out to convert fine and cohesive active ingredient and excipients, into more uniform, free-flowing granules that are optimised for downstream processing.
<h2>Achieve uniform particle size distribution for wet granulation</h2>
The High Shear Mixer Granulator from Romaco Tecpharm is configured to optimize the wet granulation process. It is used to turn a fine-powder heterogeneous mixture into a uniform granulation, with increased particle size and higher density.

The equipment offers you proper flow and compactness while having a shorter operational time. It can handle capacities ranging from 25 L to 1,400 L.The bottom impeller and the side chopper enables the intensive mixing in a short period of time. In addition, the equipment uses a synchronized system to avoid extrusion effect.

The high-shear granulator for drug formation processes the solid material down to the desired particle size, and the mixture is then pumped to the fluid bed dryer where the moisture is removed, leaving behind the granular product. During the process of wet granulation, the constituents of the oral solid dosage form blend are combined, along with agglutinative solution, to form granules with a homogenous composition.

Industrial high shear mixer granulator for drug formation

When making tablets, pharmaceutical manufacturers need to use a mechanical process, like a rolling press for compaction, to produce granules from powders susceptible to moisture and temperature. This method also applies to large-volume products where the compaction of powders requires consistent and precise control of the force applied to achieve uniform density.


<h3>Transforming dry particles into uniformly dense granules</h3>
The Dry Granulation BRC from Bohle, is a compacting system for fine solids and dry powders to form granules in pharmaceutical industries. The system is equipped with screw feeders that push the powders toward two rollers. The rollers apply precise compaction force to produce uniformly dense, ribbon-shaped products before crushing them down to the desired granule size through a cone-shaped rotary sieve mill. The granule size can be quickly adjusted using a different rotary sieve with a suitable profile. The system has a production range of less than 1kg/h up to 400 kg/h and has a hygienic design using integrated washer nozzles for an effective WIP process.

Continuous roller compactor for dry granulation of pharmaceuticals

Pharmaceutical industries employ several processes including drying, coating and granulation to create high-quality granules. Manufacturers can benefit from a single system that can complete all of these tasks simultaneously, increasing production yield without sacrificing the quality of the final product.


<h3>Coating, granulation, and drying granules by tangential fluid bed method</h3>
The Fluidized Bed System BFS from Bohle, is a system that can perform multiple processes such as coating, granulation, and drying to turn fine solids and dry powders into granules. The cone is equipped with a specially slotted air distributor plate which allows complete fluidization of particles while the tangential motion helps in achieving a uniform coating without the particles adhering to one another. Due to a relatively low fluidization height, the system does not require a high-volume expansion saving costs and production floor space.

The system can also be equipped with an online moisture measurement system using NIR technology to precisely identify moisture levels during the granulation and drying. The BFS has at least 6 filter elements that can be cleaned separately and ensure good uninterrupted airflow. To make it simple to use, the entire system is PLC controlled.

Fluidized bed system for the granulation and drying of pharmaceuticals

Powder containment is the cornerstone of chemical and pharmaceutical manufacturing. Floating particles do not only represent efficiency loss but serious hazards too. Lack of tightness during the powder discharge process leads to cross-contamination and operational health risks.


<h3>Dock transfer systems squarely in place</h3>
The ASBV active/passive valve interface by Andocksysteme locks into position, minimizing exposure of material during powder discharge. The system has two split valves – one active, one passive – that can be easily and reliably centred on each other at a tolerance of ± 14 mm.

Once the units are docked, the valve discs open simultaneously, preventing exposure of the products during transfers. The dust-tight environment achieves contamination values lower than 1µg/m3.

The ASBV solution is fitted with EPDM seals and are optional with a wide range of materials, such as PTFE, offering top-range chemical resistance. All seals are made from FDA-approved materials and can handle a wide range of temperatures as well as explosion-proof executions.

Washing the ASBV interface is simple as the system can be connected to a WIP loop to flush out residual powders. These containment solutions serve applications with an exceptional performance and are easy to be integrated. Moreover, high quality parts and reduced complexity drives simple maintenance.

High containment split butterfly valve

Andocksysteme is a specialist in developing and engineering high-quality containment docking and solutions for bulk material.

The rise of high-potency ingredients (HPAPI) is taking medication into unchartered territory. Since the turn of the century, the pharmaceutical industry has developed a wave of targeted therapeutics formulated with more potent drugs in smaller doses.

Besides producing a more effective action against their biomedical targets, these innovative medicines are also lighter on excipients and provoke fewer side effects for patients. However, they do cause considerable side effects for manufacturers.


<h3>Higher potency can be too much of a good thing</h3>
HPAPI materials pose a risk of toxic exposure to operators. Process technology is designed to meet EHS guidelines, protecting handlers from hazardous substances. At the same time, it must also adhere to GMP standards to prevent contamination. However, the real danger lies at the inlets and outlets of the machines, as <a href="https://andocksysteme.de/en/" target="_blank" rel="noopener">Andocksysteme</a> Product Manager Duncan Ehrmann points out.

“It is all well and good when a mixer is blending chemicals, or a dryer is reducing moisture,” says Duncan. “But things get tricky while the materials are transferred from the mixer to the dryer.”

There is no such thing as a fully closed system; discharge will always release particles into the air. So, the challenge is to minimize that amount to the greatest extent possible.

The industry answer is the split butterfly valve principle, joining the ‘mouths’ of two systems and opening them synchronously. But engineering the concept into an actual pharma-grade interface is another story.
<h3>Big on seals, small on parts</h3>
Andocksysteme developed a valve solution that achieves contamination values lower than 1μg/m3. A primary contributor to this degree of containment is the minimalist construction of the interface. Designed with the bare minimum of separate parts, the valves significantly restrict roaming space for flowing powders.

"We designed  our technology with large seals  to cover the openings," explains Duncan, "A bigger seal exerts higher pressure, locking the active/passive valves tighter together.”

The state-of-the-art system meets the OEB 5 levels of protection required when handling ingredients with high pharmacological and toxic effects.

HPAPI particles move around a lot during processing. Their manufacturing cycles are long and winding, but high-containment valves hold them safely within that loop.

Closing the containment loop in HPAPI manufacturing

Pharmaceutical

Pharmaceutical powders provide longer shelf life and better stability than liquid dosage forms. But the processing of pharmaceutical powders is crucial for growing segments besides pharmacy. Functional foods and cosmetics formulated with active ingredients and excipients depend on powdered forms to fulfill their promises.

Pharmaceutical powder

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

The building blocks of matter have driven the imagination of philosophers, scientists, and artists for millennia. But, for manufacturers, these elements have a more concrete existence as powders. Powder processing technology conditions these primary materials to create a vast range of products, from chemicals and foods to pharmaceuticals and ceramics.

Powder

Among all dosage forms in use today, tablets constitute the most common one. They are pharmaceutical solid dosage forms containing active ingredients and excipients such as diluents, binders, glidants, and lubricants. Using tablet making equipment, these solid dosage forms are made by compression of granules or powder blends and then shaped by molding.

Tablets

Find production technology for API Granulation, and connect directly with leading machine manufacturers worldwide

API Granulation

Which api granulation equipment do you need?

In-line continuous blender

Pharmaceutical granulator

Fluid bed dryer for pharmaceutical solid dosage form

Industrial high shear mixer granulator for drug formation

Continuous roller compactor for dry granulation of pharmaceuticals

Fluidized bed system for the granulation and drying of pharmaceuticals

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