Successfully track materials in continuous processes – Using PAT to improve material management in flow chemistry applications
MARTIN GADSBY1*, ERNIE HILLIER2
* Corresponding author
1. Director at Optimal Industrial Technologies, Bristol, United Kingdom
2. Principal Owner at EJH Consulting, Milford, Massachusetts, USA
Abstract
Continuous flow chemistry processes can greatly benefit from a Process Analytical Technology (PAT) framework that incorporates material tracking and tracing functions. In particular, when commercial-scale continuous processes are conducted in a GMP (Good Manufacturing Practices) compliant environment, information and knowledge about the movement of products is critical for quality and regulatory assurance purposes.
In these applications, a continuous track and trace system must be able to track the movement of products as well as take into account the forward and back mixing that occurs in many continuous processes. Ultimately, the solution should be able to make accurate quality predictions based on mathematical models and empirical data.
INTRODUCTION
Running chemical reactions in a continuous flow stream, rather than in conventional batches where materials are weighed and added to a batch unit operation, can deliver significant benefits to pharmaceutical manufacturers. Continuous flow chemistry applications can considerably shorten cycle times and costs as well as improve productivity, efficiency and throughput. At the same time, they enhance end product quality and consistency by using PAT-driven quality assurance strategies. These applications can slash the downtime associated with off-line quality control and testing, plus offer real-time monitoring capabilities.
While continuous processes offer a robust framework to help pharmaceutical companies deliver high-quality products more efficiently, the IT and automation infrastructure needs to provide complete visibility associated with the movement of raw materials throughout manufacturing in order to meet regulatory compliance and GMP (1). More precisely, it is crucial for pharmaceutical producers to be able to track the raw material lots that they use from process input to final batches. In other words, they must b ...
