Jakarta, 22 May 2024 – The pharmaceutical industry is undergoing a significant transformation towards a more efficient, faster, and cost-saving with the emergence of continuous manufacturing. It eliminates waiting time between unit operations which enables non-stop production.

Unlike batch manufacturing, which is segmented into multiple stages with significant downtime for quality testing and storage, continuous manufacturing is an integrated process. Materials flow seamlessly from one stage to the next, eliminating “hold-times” and reducing the risk of material degradation. This approach not only ensures non-stop production but also addresses the challenges posed by supply chain disruptions. 

Continuous manufacturing shift is driven by advancements in Process Analytical Technology (PAT) and Real-Time Release Testing (RTRT). These innovative solution are revolutionizing drug production by offering efficiency, flexibility, and quality control. 

PAT, a framework introduced by the FDA, empowers real-time monitoring and control of pharmaceutical manufacturing. By integrating analytical techniques, sensors, and process control strategies, PAT ensures consistent product quality. This is achieved through continuous monitoring of critical process parameters (CPPs) and key performance indicators (KPIs), enabling manufacturers to promptly identify and rectify deviations, minimizing product variability.

RTRT complements PAT by providing immediate product quality assessment based on in-line or at-line measurements. Unlike traditional batch testing with its time-consuming sample collection and analysis, RTRT offers instant feedback, allowing for real-time decisions about product release. This significantly streamlines the manufacturing process, reduces quality control time and resources, and ultimately accelerates the time-to-market for new drugs.

The integration of PAT and RTRT helps firms eliminate hold times, utilize the full capacity of the manufacturing lines, and bring quality testing inline. Continuous manufacturing can also help pharmaceutical industries to react more quickly to change in demand and respond more rapidly to changing markets.  As pharmaceutical companies strive to meet evolving demands for safer and more effective drugs, embracing these technologies will be crucial for maintaining competitiveness and adhering to stringent quality standards.

Stay tuned for details on our upcoming seminar featuring industry experts who will share their knowledge and experiences on continuous manufacturing with PAT and RTRT. Let’s embark on a journey towards excellence in pharmaceutical manufacturing!