White Paper – Granulation Solutions

The latest White Paper from leading pharmaceutical equipment manufacturer L.B. Bohle Maschinen und Verfahren GmbH (L.B. Bohle) provides an overview of the company’s unrivalled range of high-quality granulation solutions for forming coarser agglomerates from fine powders.

The White Paper “Granulation Variety: “Made in Germany”” reviews the whole range of granulation technologies on offer, with insights into the specific advantages of each approach contributed by Executive Director Technology, Thorsten Wesselmann.

Fluid Bed Granulation

L.B. Bohle’s BFS fluid bed granulators are distinctive in using tangential spray nozzles to apply the aqueous or alcoholic granulation medium to compress dry powder particles. The fluid contains a volatile solvent which can be removed by drying.

This approach makes for more compact installations than top- spray-systems and allows granulation, coating and drying to be combined in a single system.

A further BFS feature is the patented Bohle Uni Cone BUC®, a specially slotted air distributor plate with a conical displacement cone for batches of 1 to 500 kg. A newly developed, protected multi-purpose valve directly above the distributor plate allows dust-free suction and draining of the product container for shorter product transfer times and efficiency savings, while the geometrically similar structure simplifies scaling-up.

Single-Pot Granulation

The VMA Single-Pot Granulator series combines mixing, high-shear wet granulation and drying by vacuum, carrier-gas, or microwave heat in one process bowl. These units are built around a double jacketed GMP-compliant process tank with twin stirrers to mix and shear incorporated in the lid and emptying through a cone-shaped BTS 200 sieve via the floor outlet into an IBC container.

This combined approach offers numerous benefits, including secure containment, suitability for ATEX environments, high mixing and granulation efficiency (even at low doses), energy saving drying, limited contact surfaces for faster cleaning and changeover, and compact footprint.

High-shear granulation

L.B. Bohle’s GMA range of high-shear granulators add a binding fluid to powder in a closed tank equipped with separate agitator blade and chopper to guarantee effective mixing and granulation. The chopper prevents excessive granule growth and distributes the granulation medium throughout the product.

GMA advantages include low fluid consumption, easy discharge, high containment, easy cleaning, and flexibility in being able to control granulation by time, quantity or output.

Twin-screw granulation

The BCG twin-screw granulation machines meet the needs for continuous wet granulation and are therefore important in moving to continuous manufacturing set-ups.

The powder to be granuled is fed onto two ‘screws’ rotating in the same direction within the cylinder, thus transporting the material through the process zone and kneading and mixing it at the same time.

Advantages of this design include short dwell times down to a few seconds, fast and efficient reactions to process and quality deviations, reduced space requirements, and a fully instrumented process for 100% in-line quality control.

Dry Granulation

Continuous dry granulation is preferred by pharma manufacturers for moisture or temperature-sensitive products, and for its energy saving potential over wet granulation.

L.B. Bohle’s BRC series machines combine high product capacity with minimum material loss and outclass rival solutions by generating force electromechanically to ensure more consistent ribbon properties.

Other advantages include hygienic design and integrated washing nozzles for effective WIP wash-in-place cleaning, as well as flexibility with a wide range of cone-shaped Bohle Turbo Sieve BTS and sieve inserts available to adjust to new process and ribbon requirements. The functional GMP-compliant design and PAT tool support Quality by Design (QbD) methods.

Compact Module

The Bohle compact granulation suite combines key elements of the GMA high shear, BTS wet sieve, BFS fluid bed system, Uni Cone BUC®, cyclone separator and BTS dry sieve within one compact unit. In doing so, the process, cleaning, control, explosion protection, zone concept and qualification are closely coordinated with each other.

The compact granulation module allows for an extremely space-saving installation and provides a highly effective solution for optimized wet granulation, setting new industry standards with its technological advances and logical safety concept.

Specific advantages include the ability to install GMA and BFS into a wall side-by-side for low space requirement and minimal installation height, multi-purpose adaptability to a variety of processes, unified control panel, and easy WIP cleaning.

Resources

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