New validation laboratory opens

Diversified technology company 3M has extended its global network of Validation Laboratories serving the pharmaceutical and life-sciences industries by opening a new facility in Antwerp, Belgium. 

European customers now have enhanced access to services that help confirm compatibility between equipment and manufacturing processes. With this addition, 3M has seven Validation Laboratories spanning Europe, the Americas, North Africa and Asia.

The Validation Laboratories produce high-quality technical studies and data packages for 3M Purification products as used in customers’ processes, to ensure process integrity and to demonstrate regulatory compliance. The comprehensive portfolio of services covers microbial challenge testing, product integrity testing, chemical compatibility testing, and particle release testing, as well as test design, execution, and full documentation.

The range of validation services available from 3M’s global network of laboratories includes challenge tests such as Brevundimonas diminuta retention testing using customer process fluids and under simulated processing conditions. Mycoplasma clearance testing using Acholeplasma laidlawii and Mycoplasma orale retention testing are also available, and are increasingly important as M.orale now accounts for more than 40% of cell culture mycoplasma contamination events.

3M’s validation laboratories are also able to assess the chemical compatibility of 3M Purification products with customer fluids under expected operating conditions, taking into account factors such as the composition of the end product or intermediate chemicals, 3M Purification product materials of construction, duration of product contact, and temperature of product contact.

Particle release testing is also available for applications that require capture and identification of particles from the process stream under operational conditions.

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