Fluid Bed System

www.brinox.eu

Fluid Bed System Fluidised bed for drying, granulation and coating

Pharmaceutical industry

Technology that delivers

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High-precision engineering for large-scale innovations.

The fluid bed system is the most widely used technique for drying, granulation and coating of pharmaceutical and chemical powders and can meet the highest requirements for product quality and process flexibility.

In a fluidised bed, hot or cold air is passed through the perforated bottom of a container/bowl containing granules, powder and in some cases also micro tablets.

During granulation, the powder is lifted from the bottom and suspended in the stream of air and then adhesive is sprayed onto it. In principle, granulation is a process that gathers small 4

particles into a larger mass with the original particles still identifiable without wide agglomeration. The same quality goes for coating. Coating based on fluidized bed technology is commonly used in the pharmaceutical industry to coat small particles and tablets.

The Brinox fluidized bed system offers a wide range of flexible approaches to achieve a high-quality drying effect, granules without unwanted agglomerates, and a uniformly coated product. The possibility of CIP cleaning is a standard common feature of units produced by Brinox.

Configure, charge, process, discharge.

The unit is constructed as a vertical flow system, completed, tested, and optimised to meet customer demands and ready to be connected to site operation.

There are two product bowls available. One for drying and granulation and one for coating. Each one is individually developed to meet the needs of

an operation. A special patented swirl generator can achieve uniform coating thickness regardless of pellet size and can improve coating yield. There are automatic functions for CIP cleaning, no operator actions are needed for the complete CIP process.

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Made to bring a difference to your process Using a Brinox fluid bed system represents state-ofthe-art technology in pharmaceutical manufacturing for particle coating, granulation and drying.

With the innovative and patented swirl generation process a complete fluidisation is assured which leads to a high coating uniformity and high yields in the final product due to the absence of particle twinning. Brinox is the productive, practical and precise alternative to conventional Wurster processing. The key challenge is how to achieve optimal and homogenous

particle coating. All particles involved in the coating process, regardless of their size, should have the same coating thickness. The mass of coating deposited on the particles during the coating process should only be a function of the projected particle surface area. The results of tests indicate that in a conventional Wurster chamber (CWC) the larger pellets receive significantly more coating dispersion in comparison to the smaller ones and that this difference is significantly reduced when the Brinox SWC is used.

Thickness of the coating layer (mm)

35 30

SWC

25 20 15 10

CWC

5 0 0

0,2

0,6

0,4

0,8

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Diameter (mm) SEM - assessed thickness of the coating layer deposited on the pellets as function of the equipment spherical diameter of plot-size fraction

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Personalised solution Brinox Fluidised bed system advantages ¬

Stabilisation of the fluid flow due to rotational movement, Particle trajectory optimisation, More homogenous particle distribution, Direct influence on the coating quality due to known fluid-solid dispersal, Inline manipulation over fluidised bed boundary conditions, Process time reduction, Flow of the product to be dosed tailored to the needs of the client, accordingly dimensioned elements of the unit, Entirely automatised functions for control of the operation, Entirely automatised functions for CIP cleaning, Pilot scale system installed at Brinox to allow the customer to test the process, product and equipment.

General technical data ¬

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Wide range, from laboratory size and up to product batches of 10–600 lit, Single fluid bed unit or system with interchangeable modules.

All parts in contact with the product made of material AISI316L, Standard, widely used measuring instruments and components for automation, Certified explosion pressure-shock-resistant device, which can withstand explosion shock pressure up to 12bar, Containment-suitable version.

Partner Profile “BRINOX is a partner that brings in more than 30 years of experience. Its excellent reputation in the pharmaceutical, biopharmaceutical, and food industries is a guarantee of its flawless process systems.”

BRINOX is an innovative European company specialising in fast, efficient, cost-competitive, and personalised process systems.

BRINOX is on the way to becoming Europe’s first-choice partner for customised process solutions. The company focuses on developing, producing, and installing solutions that optimally address the complex challenges of automated processes.

With its headquarters in Slovenia, partners in Europe and Russia and over 250 highly skilled employees, the company has adopted a system of ambitious corporate values based on the customer-centered approach.

Regulatory compliance

Engineering

Client support in the field of regulatory compliance, generating customised plans for increasing productivity in line with cGMP requirements

A precise definition of the functionality of process systems, of the links between them and development of the process flow chart (P&ID diagram). Designing of every process component, anticipating any possible process problems and ensuring high levels of efficiency and productivity.

R&D A rigorous approach, advanced tools and collaboration with leading experts and institutions

Conceptual design

Manufacturing

Development of an optimal solution that is cost-effective, high-performing, and GMP compliant

A high level of flexibility and adaptability to ever-changing demands, guaranteeing the highest possible quality control and respecting budget and time constraints

Testing

Quality control and validation

Having our own testing facilities and strict test plans allows extensive FAT prior to delivery and successful SAT.

Assembly On-site assembly is provided globally, regardless of the manufacturer’s location, ensuring proper installation and guaranteeing problem-free functioning.

Automation

Monitoring quality within the manufacturing system, monitoring and addressing any errors or disruptions.

Assistance during validation procedures, including complete documentation support.

Maintenance Intervention, repair, and assembly. Spare parts for all equipment installed, engineer-supported interventions, online support and preventive check-ups.

Comprehensive automation solutions are based on the ISA S88.01 standard, 21CFR part 11 guidelines, PLCSCADA open solutions, and GAMP 5 guidelines 9

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PH201804 - EN Photo: © Marko Prezelj Certified management system Brinox d.o.o.

Slovenia

Brinox d.o.o.

Sora 21 SI-1215 Medvode, Slovenija T: +386 1 361 97 30 info@brinox.eu www.brinox.eu

Brinox Deutschland GmbH Maria-und-Georg-Dietrich Str. 2 77652 Offenburg Deutschland T: +49 (0) 781 970 678 10 info@brinox.de

Brinox Ireland & United Kingdom Chambers House, Ellison StreetCastlebar Co. Mayo, Ireland T: +353 94 9026821, + 353 87 6264360 info@brinox.eu

ООО «БРИНОКС РУС» Кутузовский пр-т 9/2, офис 98, 121248 Москва Российская Федерация T: +7 499 243 71 55 russia.office@brinox.eu