Millipore updates control software for separations
its separation and purification systems, bringing the package into
line with recent regulatory requirements such as the US Food and
Drug Administration (FDA)'s 21 CFR Part 11.
The Common Control Platform Version 6 (CCP v6) software is compatible with the Windows XP operating system and a single interface links biochromatography and tangential flow filtration (TFF) systems to a single control and data handling system.
A built-in recipe manager ensures that system operators only select from an appropriate pool of recipes, which are set by an administrator and related to the batch in process. Any edits or modification to a recipe is accompanied with an electronic signature, in keeping with the 21 CFR Part 11 regulations.
In addition, the operator's ID is logged with every event or data point, so with automatic and secure data acquisition, CCP v6 software provides an information trail for process review and regulatory compliance.
Millipore also notes that CCP v6 improves the management of the connectivity between diverse biopurification systems. The software monitors process parameters and enables batch reporting. "As a result, applications developed in the laboratory can be quickly and easily scaled up," it said.
