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Gerteis customer confirms roller compaction advantages
Jona, Switzerland: – In a recent magazine article, contract development and manufacturing organization (CDMO) PCI Pharma Services attests to the significant advantages that roller compaction dry granulation has delivered, compared with traditional wet granulation.
Interviewed in Tablets & Capsules Solid Dose Digest, PCI’s Director of Scientific Affairs, David O’Connell, says roller compaction provides an alternative to wet granulation, with its well-known drawbacks for some moisture- or heat-sensitive blends or blends with low melting points.
“Dry granulation can increase the bulk density of powders and their particle sizes to ensure a better flow of distributed material, an important factor in the manufacture of tablets and capsules using high-speed production equipment,” David O’Connell tells the magazine.
Breaking down ribbons
More specifically, the roller compaction method provides an alternative to ‘slugging’, in which dry powders are aggregated into large compacted slugs of powder blend. Instead, roller compaction compresses the material into a solid, densified ‘ribbon’ sheet that is easier to mill down into granules.
Roller compactors compress the powder by feeding it via gravity or auger feeder through a gap between two directly opposed, counter-rotating rollers. Following compaction, a milling system, such as an oscillating mill, breaks the ribbon down into granules of a specified particle size.
The mill uses a screen with a sizing mesh that limits the maximum particle size. The oscillating mill provides a gentle process that avoids creating fines as far as possible within the resulting granules, allowing further processing of granulate into tablet or capsule form with increased confidence of dose uniformity.
Floating gap advantage
O’Connell also mentioned the effectiveness of the ‘floating gap’ system in avoiding the inconsistent ribbon densities encountered with fixed gap rollers. The system adjusts distance between the rollers according to powder feed rate to maintain constant pressure.
PCI had found floating gap roller compaction provided a more consistent density of ribbon, resulting in a more uniform and homogeneous granulate.
“With a moisture-sensitive blend, reducing potential impurities could prove very difficult when using wet granulation. Also, roller compaction is more energy and time efficient; the lack of a need for a drying stage lowers energy costs and produces the granules in less time,” said O’Connell.
Gerteis Maschinen + Processengineering AG is a Swiss-based company that has rapidly established itself as a world leader in the field of premium roller compactors. The company’s products and services cover all aspects of dry granulation processes, with unparalleled experience in this field built up since the company was founded in 1986.
Gerteis manufactures a wide range of high quality containment roller compactors that are versatile enough to process a vast range of powders, even notoriously problematic ones at both laboratory and production scales. The company’s patented technologies are widely used by the pharmaceutical, chemical and food industries.
As well as manufacturing machinery, Gerteis offers complete solution packages that help customers increase productivity including support on identifying ideal formulations and in-house training courses on dry granulation processing. Gerteis constantly seeks to expand its knowledge on dry granulation, participating in numerous research collaborations with German universities.
PCI Pharma Services is a contract development and manufacturing organization (CDMO) that provides integrated full service offerings to leading companies in the global healthcare industry. It possesses in-depth expertise in taking compounds from early stage development through to commercial launch, delivering speed to market for customers.
PCI’s core services include analytical services, formulation development, clinical trial supply, commercial manufacturing and packaging, QP services, supply chain management, storage and distribution.
Further information at: https://pciservices.com
Click on Tablets & Capsules to see original article.
PCI Pharma Services purpose-designed high containment Gerteis roller compaction unit
Using roller compaction at PCI as granulation process for high-potency blends
Contained sample port