EMPAT, a Fully Automatic Aseptic Sampling System for Biologics Manufacturing
Product News Jul 19, 2012
EMPAT is an automated sampling system for research, product development and commercial-scale biopharmaceutical manufacturing.
It collects samples directly from bioreactors aseptically and automatically, saving time, removing the risk of potential error and improving the precision of quality control measures.
The system is easy to install and program, operates continuously around the clock and seamlessly integrates with existing data systems giving users real-time process characterization.
EMPAT supports the 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.
Automated QC sampling supports better product yield and reduced batch failures.
The EMPAT Automated Aseptic Sampling System is available from Alfa Wassermann Separation Technologies, a leading supplier of process ultracentrifugation equipment for biologics manufacturing.
The EMPAT system can be set up in 10 minutes to provide 24-hour, walk-away operation.
Through a menu of pre-authorized and programmable sampling procedures, the system automatically collects samples for transfer to gamma irradiated, single-use bag sets.
In between sample extractions, 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.
“EMPAT is designed to guarantee the industry achieves a state of continual improvement,” says Kim Muro, the AWST North American Director of Sales.
“Proper utilization of EMPAT delivers an increased level of scrutiny for manufacturers that more than satisfies industry requirements to ensure process verification,” she added.
Validation binders are available. EMPAT accommodates both GMP and non-GMP environments. The system may be custom configured upon request.