Automating sample retrieval during the manufacturing process has been one of the trickier obstacles to achieving Quality by Design (QbD).
The challenge has been to maintain aseptic conditions, but a new product called Empat, from Alfa Wassermann Separation Technologies (AWST), a supplier of ultracentrifugation equipment for biologics manufacturing, claims to be achieving this goal.
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.
AWST says the system is easy to install and programme, operates continuously around the clock and seamlessly integrates with existing data systems giving users real-time process characterisation.
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 system can be set up in 10 minutes to provide 24-hour, walk-away operation. Through a menu of pre-authorised 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 authorisation and paperless operation meets 21CFR Part 11 guidelines.
‘Empat is designed to guarantee the industry achieves a state of continual improvement,’ says Kim Muro, North American director of sales at AWST.
‘Proper utilisation of Empat delivers an increased level of scrutiny for manufacturers that more than satisfies industry requirements to ensure process verification,’ she added.
Empat accommodates both GMP and non-GMP environments. The system may be custom configured upon request.
