AN AUTOMATED sampling workstation that collects samples directly and aseptically from bioreactors can save time, remove risk of error, and improve quality control, says Alfa Wassermann.
The company says its Empat system is easy to install and program, operates continuously around the clock, and integrates easily with existing data systems.
Empat supports the US Food and Drug Administration (FDA) Quality by Design concept of building quality into the manufacturing process by continuous sampling of products in-process, facilitating the testing protocols used for risk assessment and process validation.
Alfa Wassermann Separation Technologies is probably best known as a supplier of process ultracentrifugation equipment for biologics manufacturing. It says this new expansion into automated sampling for research, product development, and commercial-scale biopharma manufacturing is proving successful.
Empat can be set up in ten minutes to provide 24-hour, walk-away operation, it adds. Through a menu of pre-authorised and programmable sampling procedures, it automatically collects samples for transfer to gamma irradiated, single-use bag sets.
A patented method is used to avoid cross contamination between samples and to assure sterility. Operating and batch data are captured, stored and archived in an SQL database, with capabilities for report generation and barcode label printout for sample identification. A secure touchscreen user interface with multilevel password authorization and paperless operation adheres to 21CFR Part 11 guidelines.