Although release by exception and real-time release are not yet a reality for the majority of pharmaceutical and biotech manufacturing processes, Michalle has heard that a few companies are managing to move forward with this concept within the context of certain well-characterized processes.
So what exactly is release by exception?
Release by exception is possible in cases where a process is well characterized and the critical process parameters and critical quality attributes are well defined and understood. The product (or intermediates) could be released automatically as long as there are no deviations within the manufacturing process.
While this may be a stretch yet for many processes, there are certainly many tools that can enable companies to get closer to reaching this goal. In earlier posts, such as Implementing Process Analytical Technology [PAT] and Continuous Process Verification, we highlighted some of the technologies and capabilities that can support this endeavor. Fundamentally, tools that can eliminate variability in the process, enable right first time production, and provide real-time measurement of Critical Quality Attributes will enable manufacturers to reach these goals.
Michalle points to an array of technologies and services to implement process control for pharmaceutical and biotech facilities. Technologies such as Syncade Smart Operations Management Suite, DeltaV Process Automation, synTQ PAT platform (partner), and measurement instrumentations and control devices by Rosemount, Fisher Valves and Instruments, Micro Motion, and ASCO all work together to provide a solution that enables quality, compliance, and right first time operations to enable release by exception.At the base of this solution is the ANSI/ISA-95 (S95) level 1 & 2 capability to see and control the process in real-time. When DeltaV Batch analytics are added in along with PAT, process variability can be minimized and critical quality attributes can be predicted in real-time to ensure that the batch is on the right trajectory.
Syncade software is used to ensure that all of the manual operations are managed correctly in conjunction with the automated steps. Adding these workflows helps manage the right-the-first-time pieces of the puzzle. For example, ensuring that the trained personnel are adding the right material to the right batch at the right time and that the equipment is in the right state for use.
While the technologies continue to advance and experience is gained through the application of these technologies, more pharmaceutical and biotech manufacturers will get closer to a release by exception and real-time release mode of operation.
If you’ll be joining us in Orlando, make sure to visit with Michalle and the Life Sciences consultants to discuss the enablement of release by exception. If you can’t join us, make sure to connect and interact with other Life Sciences professionals in the Life Sciences track of the Emerson Exchange 365 community.