Clean environments: meeting modern drug production challenges

Published: 3-Dec-2014

New medicinal therapies are seeing rapid development but face many price pressures and regulatory challenges. George Wiker, VP, M+W Group and Kurt Gilson, VP, Western US, Total Facility Solutions, discuss the impact on facility design

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A clean production environment is a critical element in the manufacturing process for pharmaceutical products. Working within a clean environment promotes better containment of the ingredients used in pharmaceutical manufacturing – a critical issue when producing antibiotics, steroids, cytotoxics, highly potent active pharmaceutical ingredients (HPAPIs) and radiopharmaceuticals – as it provides the necessary protection for workers. A clean environment is also required to protect finished drugs from environmental contaminants, and to mitigate any cross-contamination from other active pharmaceutical ingredients (APIs) being produced.

Evolution in the pharmaceutical and biotechnology industries and changes in regulatory authority standards and requirements are creating challenges across the industry

Evolution in the pharmaceutical and biotechnology industries and changes in regulatory authority standards and requirements are creating challenges across the industry. Because cleanrooms have such an important role in the drug production process, the designers and contractors who create the clean environments have an important part to play in meeting the industry’s challenges in achieving cost-effective and timely production of safe and effective drugs.

Cost is one of the key challenges facing the biopharmaceutical industry at the moment. The overall R&D costs of a drug from start to finish are very high, approaching US$1bn or more per product that makes it to the marketplace; drug developers are therefore looking to manufacturers not only to improve cost-effectiveness and net present value (NPV), but also to decrease the time to market.

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