Faster cleaning validation in pharma plants

Published: 8-Aug-2013

Cleaning validations for manufacturing equipment can mean frequent downtime and unwanted costs. Geoff Carr, Director, analytical development, Patheon in Ontario, looks at the benefits of LC-MS for development and execution of cleaning test methods

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All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive, disposable systems exclusively.

Using the latitude available in current good manufacturing practices for the 21st century, scientific data evaluation and risk-based approaches can streamline the process. By developing sound and defensible programmes with rapid and specific testing, cleaning validation can be more efficiently and effectively implemented.

Contract manufacturer Patheon provides the highest quality products and services to around 300 leading pharmaceutical and biotechnology companies. Its integrated network consists of 18 sites, housing 14 commercial contract manufacturing facilities and 12 development centres across North America and Europe. As a result, Patheon handles many different molecules and products for its customers.

Within any pharmaceutical manufacturing facility, it is critical to be sure that following the manufacture of one product, the equipment has been thoroughly cleaned to avoid risks of any carryover into the following product. Achieving this requires the application of validated cleaning procedures. Such procedures require that, following execution of the intended procedure, samples are taken and tested for any product residues.

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