Broadbent supplies GMP centrifuges
Four validatable Good Manufacturing Practice (GMP) centrifuges, manufactured by Broadbent Centrifuges for Hungary's leading pharmaceutical manufacturer Gedeon Richter, are to be installed for multi-batch collection of active pharmaceutical ingredients (APIs) at a new production facility in Dorog.
Gedeon Richter operates within the strict guidelines, recommendations and inspection procedures of the FDA, achieving high levels of quality control through the utilisation and maintenance of clean processing facilities. All plant and equipment installed in the new factory will conform to standards of GMP and the very latest GAMP 4 requirements.
Three 440l capacity bottom discharge vertical centrifuges and a 200l capacity horizontal GMP Peeler centrifuge - will be installed to de-liquor APIs on the company's new chemical synthesis production line.
Broadbent/Rina GMP Peelers, which were designed in conjunction with Riera Nadeu, are already installed at Dorog, where they have helped improve and maintain the quality and consistency of its products and increase the throughput rate.
To meet the contamination-free standards of 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.
contamination risk
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 CIP 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 600 G.