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Pharmaceutical Processing News
News Release from: GEA Niro | Subject: PTS
Edited by the Processingtalk Editorial
Team on 02 July 2007
Pharma R+D facilities for small volume
projects
Niro in Copenhagen has recently installed a pharmaceutical spray dryer Pharmasd, size PSD-1 in its Pharmaceutical Test Station (PTS), to add further flexibility to the facility
The new plant joins the much larger PSD-4 currently in place to add greater flexibility to the facility allowing the processing of much smaller quantities of active ingredient - including high potency actives - during the development of drugs The PTS offers Niro customers the facilities to spray dry pharmaceutical material to study safety, stability and toxicology and for clinical trials
This article was originally published on Processingtalk on 12 Jun 2007 at 8.00am (UK)
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It allows Niro customers to pursue projects without the need for early investment in plant or a specialist workforce.
The facility has been built to GMP standards with a clean room rating of 100,000; includes process control compliant to 21 CFR part 11; and can evaluate spray drying processes using both aqueous and organic solvent feeds.
The PSD-1 is a smaller version of the PSD-4 with the same features and operating parameters, the only difference being the feed rate of up to 10kg/hour compared with up to 400kg/hour for the PSD-4.
The ability of the PSD-1 to handle smaller quantities allows the development of high value or highly potent compounds that would be uneconomic or inappropriate to handle in larger volumes.
The PTS helps Niro customers achieve the best product quality for the chosen drug delivery method with the minimum of development time and increased security of outcome.
Furthermore, test work can be performed during the project implementation phase giving valuable input to the validation process, providing training for the customer project team and reducing the commissioning period of the commercial production unit.
Svenn Ryberg, the vice president of the Niro Pharma Division, explained that the PTS represented a unique co-operation between Niro and its customers.
"The PTS allows us to work with our customers, combining our expertise to optimise processes and maximise the clinical effectiveness of new products," he said: "The installation of the PSD-1 will allow us to offer this service for a much wider range of projects".
Niro is recognised as a pioneer in the use of spray drying for final solid dosage drug delivery both in US, EU as well as in rest of world.
This extension of the service offered by the PTS has further strengthened this position.
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