Skyepharma upgrades powder size reduction capabilities

Saint-Quentin-Fallavier, France: – Fully-formed contract development and manufacturing organisation (CDMO), Skyepharma Productions S.A.S. (Skyepharma), has ramped up its powder size reduction capabilities in oral solid dosage form manufacturing with investment in leading-edge Frewitt FlexMill grinding and sieving technology.

The Frewitt FlexMill HW-3 machinery now installed at Skyepharma’s recently expanded Saint-Quentin-Fallavier production site will allow the CDMO to add further value for clients with powders that are subject to further particle size reduction by grinding and sieving, following the granulation process.

This will enable Skyepharma to further improve product quality and meet the most demanding regulatory standards, as well as speeding time-to-market.

Easier filling

Frewitt ‘s FlexMill HW-3 is a Hammer Mill that is known in the pharmaceutical  industry for its high-speed rotating blade grinding action that produces more homogenous granules with more uniform particle size distribution (PSD)  that make capsule filling smoother and easier.

Use of the Frewitt mill directly impacts product manufacturing duration by avoiding potential difficulties during the filling phase, accelerating total production process.

Other advantages from the upgrade include increased yields, higher rates of moisture removal due to an excellent gas-particle constant, reduced drying times, lower capital and maintenance costs, and reduced energy consumption.

Faster tech transfer

The FlexMill process further reduces time to market by enabling successful first time tech transfer and it was this requirement on the part of a key client that was the initial impetus for Skyepharma’s acquisition of the hammer mill to join its equipment fleet, replacing a previous oven drying system with fluidized bed technology performed at previous sub-contractor, prior to technological transfer.

FlexMill HW-3 can perform size reduction at speed up to 7000 rpm, with a mechanical design that allows micronization of active ingredients and excipients.

cGMP design

The Hammer Mill’s pulverizes powders between high-speed rotating blades before final grinding through its milling chamber to produce very fine particles down to 0.2 mm. are produced while they are. The chamber complies with current GMP guidelines, using a seamless monobloc design to avoid risk of cross contamination.

The Frewitt HW-3 installation at Saint-Quentin-Fallavier also includes expansion modules, allowing it to be tailored to a range of pharmaceutical powder processing applications. .

“This latest collaboration between our trusted equipment supplier Frewitt to carry out requested improvements and finalize an industrial transfer project has been very effective,” commented Skyepharma Production Supervisor Jean – René.

“Our operational industrial process skills combined with those of our Pharmaceutical Development Team have enabled us to respond favorably and with a reactivity praised by our customer. Congratulations are due to the whole Skyepharma team for taking up this challenge,” said Jean – René.

About Skyepharma Production

Skyepharma Production S.A.S. (Skyepharma) is a specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.

As an integrated CDMO, the company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.

The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialization and Aggregation.

Skyepharma also provides a range of support services that help  client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.

More at: https://www.skyepharma.fr/.

Resources

Click on Skyepharma new sieving equipment for powder size reduction in oral solid dosage form manufacturing for further information.
Click on Frewitt FlexMill HW-3 for technical details.