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ATRS Instrument: Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing.

EU contribution: EUR 50 000

Objective: The objective of the overall innovation project is to develop a novel instrument to measure and control pharmaceutical drug potency during manufacture at sub-second analysis speeds. This will significantly reduce the cost of quality testing, reduce the dosage variability that a patient receives, reduce production waste and solvent disposal and address challenging new regulatory testing guidelines.

Pharmaceutical companies, in response to regulators (such as the US FDA) setting direction and guidance, need to better understand and control their processes. Real-time release testing (RTRT) and Quality by Design (QbD) are promoted by regulators as their vision of where quality must go; pharmacopeia guidance supports that vision.

Cobalt has developed a successful, patented, high speed quantitative analysis technology called transmission Raman spectroscopy (TRS), which measures drug potency of intact tablets and capsules. When used during production ( on-line ) in combination with an automated physical tablet testing system, TRS will enable immediate release of drug product without off-line analysis in a quality control (QC) laboratory.

Project completion date : 2015-10-01 12:00:00

Major organization : COBALT LIGHT SYSTEMS LIMITED

Address : 174 Brook Drive, Milton Park,Abingdon,

Oxfordshire, OX14 4SD,

Country :United Kingdom

Email : info@cobaltlight.com

Url : https://www.cobaltlight.com

Financier : European Union (EU),

Financier address : European Union (EU)

Rue de la Loi 200/Wetstraat 200,

B-1049 Bruxelles/Brussels,

Belgium

Tel: 32-2-2999696, 2993085

Fax: 32-2-2961749

Url: ec.europa.eu/

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Publication:Mena Report
Date:Jun 17, 2015
Words:243
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