Validatable GMP centrifuges in pharmaceuticals

Validatable GMP centrifuges for the leading Hungarian pharmaceutical manufacturer Gedeon Richter, are to be installed for collection of active pharmaceutical ingredients at a new production facility

Four validatable GMP centrifuges, manufactured by Broadbent Centrifuges for the leading Hungarian pharmaceutical manufacturer Gedeon Richter, are to be installed for multi-batch collection of active pharmaceutical ingredients (APIs) at a new production facility in Dorog.

As a leading pharmaceutical supplier to world markets, Gedeon Richter operates within the strict guidelines, recommendations and inspection procedures of the Food and Drug Administration (FDA) - achieving high levels of quality control through the utilization and maintenance of clean processing facilities.

All plant and equipment installed in the new factory will conform to standards of Good Manufacturing Practice (GMP) and the very latest GAMP 4 requirements.

Incorporating some of the latest innovations in centrifugal technology, the Broadbent centrifuges - three 440 litre capacity bottom discharge vertical centrifuges and a 200 litre capacity horizontal GMP Peeler centrifuge - will be installed to de-liquor APIs on the company's new chemical synthesis production line.

The decision to use Broadbent centrifuges resulted from the company's pro-active approach to customer service and the reliable performance and benefits achieved with existing machines on Gedeon Richter processes.

Broadbent/Rina GMP Peelers, which were designed in conjunction with Riera Nadeu, are already installed at Dorog, where they have helped Gedeon Richter improve and maintain the quality and consistency of its products and dramatically increase the rate of throughput.

The Peeler innovative GMP design ensures continuous operational cost-effectiveness through an ability to achieve and maintain manufacturing efficiency, increased production and high quality products.

These machines also require very little maintenance.

To meet the contamination-free standards of Good Manufacturing Practice (GMP) and comply with international validation standards, Broadbent/Rina Peeler Centrifuges have no 'dead' areas inside or out and incorporate a fully opening front-end casing which facilitates safe operator inspection of the interior.

To eliminate any risk of contamination to the front-end process area, the machines are built to a 'through the wall' design - allowing rear access to the services side if the centrifuge, which can be easily and speedily maintained without entering the process area.

A 'clean-in-place' system ensures that there is no contamination between batches and maintains total cleanliness during product changeover.

The machine's automatic peeler knife mechanism, for cake discharge and 'heel' removal, provides complete batch-to-batch containment and dramatically reduces the operating cycle by removing solids at high speed.

The three new Broadbent 440 litre capacity vertical basket centrifuges, also manufactured to a GMP design, have an ability to work automatically, operate on a semi-continuous basis and handle APIs without damaging the structure of the material.

The ability of these machines to operate over a wide range of speeds, enables material to be separated without over-compaction and extrusion, whilst maximising product recovery at a relatively low centrifugal force of 600g.

As the machines supplied to Gedeon Richter are required to process solvent-based materials, they are to be installed with nitrogen purging systems and air de-purge facilities.

In the interest of safety, these systems are installed to remove the build-up of potentially explosive vapours and keep the centrifuge atmosphere to a safe level of oxygen during processing and discharge.

Operating as an integral part of each centrifuge, the purging systems are controlled by the main centrifuge control system and incorporate a separate screen on the operator interface that allows the operator to monitor and control the purge.

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