Closed Granulation Plant Granulation in the Next Dimension

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It sounds like the famous squaring of the circle: high-capacity OSD production in a limited space, with the integration of one of the largest granulation lines in the Middle East added to the mix. Below, we give insights into a project of superlatives.

Markets in Egypt are driven in particular by rapid growth in the country’s population, which has increased from 68 million in 2000 to over 106 million in 2022. Pharmaceutical manufacturer Al Andalous was therefore eager to increase its capacity to match the needs of this growing market by producing affordable generic pharmaceutical products — in premium quality — for Egyptian patients. In addition, the company wanted to achieve better monitoring and control of its operating parameters.

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Specializing in the production of branded generics, Al Andalous started its business in 2007. The company has now become one of the fastest-growing pharmaceutical companies in Egypt. As a result of its success in the Egyptian market and to fulfill demand in both the Egyptian and export markets, the company decided to build its own production site in the city of 6th of October, just outside Cairo. With a total area of 14,000 m2, the factory meets the most recent Egyptian MOH regulations as well as EU, WHO and cGMP standards.

The heart of the new production facility is an efficient granulation line with a high production capacity. A durable production line with modern automation and a closed system to ensure homogenous and repeatable granulation was crucial for Al Andalous. The company chose a granulation line from Diosna combining a mixer-granulator and a fluid bed dryer with a capacity of 1,250 liters.

Challenge: Lack of Space and a High-Capacity Machine

A granulation line of such a huge size presented the project partners with a major task — the installation of one of the biggest machines in the market in an area that is rather small in comparison to the machine capacity. At the same time, they had to make sure that workers were able to move freely in the room and perform a variety of tasks around the machine. This required meticulous attention to fit the granulation line into the required space and ensure good maneuverability inside the room for both workers and materials.

Containment in the production of solid formulations

With these containment solutions you are on the safe side

To fit the limited height of the production area the Diosna engineers created the lid of the high-shear mixer as a swiveling design while allowing optimal product transfer between the granulation components. It was necessary to create an opening in the building’s concrete ceiling to fit the towering height of the 1,250-liter fluid bed dryer. The fluid bed dryer was then embedded into the room through the concrete ceiling opening.

The fluid bed dryer is executed in a 12-bar shock-resistant design and is thus enormously heavy. Very careful maneuvering was of great importance. The machine was moved into the designated production area under the constant supervision of both companies’ engineering teams. Thanks to meticulous planning and a skillful coordination, the machine was installed and run while the factory remained fully operational.

Batch Multiplier: Optimized Processes

Al Andalous aims for efficient granulation processes and continuous product transfer between granulation components, in order to run more batches with high granulation efficiency and yield.

The material flow between the different machine components takes place through a closed and automated system to ensure dust-free product transfer between the granulation components, minimizing product loss and increasing yield. Feeding starts from a handheld vacuum transfer lance in the high-shear mixer, which sucks the powders into the mixer. The product is then mixed, and a binding solution is added to the powder to create granules in the cylindrical-conical high-shear mixer where the product moves in 3D motion.

Homogeneous Product Quality Thanks to Fluidized-bed Technology

What Really Matters with Fluidized-bed Technology

The highly efficient mixer, with optimum product flow thanks to the geometry of the mixer and impeller, achieves excellent mixture homogeneity and high yield. The binder solution is added to the mixer through a peristaltic pump. After reaching the granulation end point, the wet granules are discharged to the integrated conical mill to be then pneumatically transferred into the fluid bed dryer.

The product is transferred through the tangential inlet positioned in the fluid bed dryer, which works along with the air distributor plate that has tangentially aligned air passage openings. This creates an even better air circulation and avoids deposits on the wall, for more yield. The air distributor plate is fixed centrally instead of via a flange, creating a bypass air seal that avoids dead zones and product accumulation on the sides. After drying, the granules are then discharged through a vacuum conveyor to the dry mill, which is finally discharged into intermediate bulk containers (IBCs).

Production Synchronization — Time and Quantity Effects

Flexibility in the processing of batches was an important aspect within this project for Al Andalous. The company wanted to produce two different batches in the same area. A through-the-wall installation concept was a feasible solution. The high-shear mixer and the fluid bed dryer are thus implemented in different rooms. This gives the opportunity to start the granulation of the next batch while the first batch is in the drying phase.

When it comes to spray technology, flexibility is not neglected either. Components that can be retrofitted, such as top and tangential spray or bottom spray processes, can be easily implemented. The machine also has a police filter deduster installed, paving the way for an easier and less costly installation of a Wurster spraying system in the future.

Automation and Control via Two Operator Interface Terminals

The pharmaceutical company’s need for simultaneous production monitoring and process control was covered by Diosna’s 21 CFR part 11 industrial PC control system. The user-friendly HMI ensured that the line operators have excellent control of the process and monitoring of the line. In addition, they can operate the machine via two identical interfaces and visualize both machines from any of the operator terminals.

The operator can run each machine separately when needed. Important parameters like the differential pressures of the inlet and exhaust air filters for the fluid bed dryer are monitored with no need to enter the technical area. Alarms give appropriate warnings if any process value is exceeded.

The Ideal Granule

From the Lab to Production — Letting You into the Secret of Successfully Scaling-up

An automated and easy to use cleaning process brings great benefits in speeding up production in the plant. In this project Al Andalous focused on minimizing the need for operator interference in the cleaning, along with easy cleaning validation.

The line components are cleaned using the WIP station. The operators can also add detergents to the cleaning process automatically. The high-shear mixer shaft seals are cleaned using an automated CIP system. The main mixing tool can also be raised automatically after cleaning to confirm the cleaning and to make it easier for the cleaning validation activities to take place. The high-shear mixer is also equipped with a detachable spray ball to perform a full automated WIP.

For cleaning of the fluid bed dryer, the operator lowers the filters and removes them. Then the operator starts the automatic cleaning. All components such as sampling tools and the pneumatic conveyor are involved in the cleaning process. Within the project, the CIP and WIP system was developed and realized according to Al Andalous’ vision of optimized production.

Doubled Capacity and Ready For the Future

Looking back, the project was a complete success for Al Andalous. The granulation system line has been put into operation and is working to the customer’s full satisfaction. The requirements in terms of functionality as well as space utilization were fully met. This line has doubled the batch capacity from 500,000 tablets to 1,000,000 tablets.

The premium quality of the machine means current and future increasing capacities can easily be dealt with. The machine has helped to achieve much better granulation efficiency and a higher output. In yet another highlight: the granulation line can also be upgraded with additional functions such as spray granulation and pelletization techniques. It is a firm foundation allowing Al Andalous to offer a competitive production portfolio in the future. n

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