Advanced Process Control: Bridge the Gap

This quick, one-time registration gives you access to members-only site benefits. A thirty-year focus on risk aversion has left a deep wound in the pharmaceutical industry. Manufacturers are still far more focused on avoiding mistakes than they are on continuously improving their processes. For many, quality is still measured more by the degree of error-free documentation than it is by fundamental process knowledge. Nowhere is this wound more apparent than in the drug industry’s slow adoption of process control and automation — in particular, advanced process control technologies. Advanced Process Control (APC) software, widely used in the petrochemical and food industries, manipulates key process variables to achieve one or many objectives simultaneously; for example quality, yield, energy efficiency and waste reduction. By providing a direct, real-time connection to any drug manufacturing process and APC platforms, Process Analytical Technology (PAT) opens up new possibilities for manufacturers. While cultural issues remain a challenge, the basic infrastructure required to sustain PAT, both for IT and for automation, has not yet become widely deployed within the industry. In fact, the degree of “evolution” or readiness for advanced control varies between drug companies, and even between different divisions or manufacturing plants within the same company. Some facilities may be highly automated, using manufacturing execution systems (MES), distributed control systems (DCS), electronic batch records (EBR), data historians, laboratory information management systems (LIMS), asset management systems, and enterprise wide resource planning (ERP) software. Others are limited to more primitive chart recorders, and operators must record data manually onto paper batch records. These differences have a staggering impact on a manufacturer’s ability to analyze data and control processes, to take effective investigational corrective and preventative actions, and to continuously improve processes. Nevertheless, the pharmaceutical industry is evolving toward more advanced process control as it embraces the concepts and