The objective of this paper is to provide an outlook on emerging Collaborative Production
Management (CPM) tools. It will discuss these CPM tools in relation to material transfers
(ingredient addition) in Batch manufacturing. Illustrating what collaborative initiatives these tools are likely to support, why they are required and how they may be deployed. The concept of collaborating is an old concept, but Collaborative Production Management, and the notion of CPM tools is a relatively new manufacturing trend. One that has been revitalized by the internet and the advent of more open manufacturing systems. Today global measurement and control suppliers find they are being pushed hard by manufacturers to increase their development momentum in this emerging area of collaborative production management tools.
In this paper (and associated presentation), the requirements to manage various levels of batch recipe within the pharmaceutical and other sectors within the Life Sciences sectors industry will be discussed, as well as the requirements to maintain secure batch records, including compliance with various electronic records and electronic signatures guidance.
Examples of how this can be achieved within an ERP solution (without the need for a separate MES level batch or recipe management solution) will also be discussed.
21CFR11 took effect in August 1997 with little observed regulatory activity. However, that has changed and increasing numbers of FDA warning letters are being generated for software used for GMP, GCP, or GLP (GxP) purposes. This presentation addresses the impact of 21CFR11 on automated manufacturing systems and processes. Included is an overview of 21CFR11, a discussion of the processes needed to reach compliance including 21CFR11 interpretation, assessment and remediation activities, and some issues for legacy automated manufacturing systems. It will speak to the compliance issues for hybrid systems where there is a multiplicity of options between totally paper based and totally electronic systems.
Kathleen Waters, Manager - Automation IT, Genentech Inc.
When presented with the problem of having to increase capacity 25% for a $100M/yr DuPont fluorochemical business, the solution was to fully automate the bottleneck of its supply chain, a batch process. Although the process already had a DCS, it was not nearly used to the potential it could be if additional instrumentation and automation software were installed. The journey taken to complete this solution taught us a lot about how to properly run a batch automation project.
Upon completion of the project, we were presented another challenge. DuPonts largest competitor withdrew from the market dramatically increasing product demand. With no additional capital, we were able to further increase capacity another 40%.
John W. W. Wood Jr, Technical Engineer, DuPont; Vernon F. Morenas, R&D Engineer, DuPont
The benefits of applying the S88.01 standard have been well proven in the industry, although most users have only scratched the surface on achieving these benefits. Some of this dilemma can be attributed to poor application of the standard by users; much can be traced to deficiencies in current tools that are available to the user. The S88.01 batch control standard has been around for five years. Ample time has been available to allow the appropriate tools to be developed that will allow users to take full advantage of the S88.01 standard. Most tools still do not provide enough needed features and flexibility. This paper will discuss ways of improving user application of the S88.01 standard and some of the deficiencies of currently available tools.
Thomas G. Fisher, Operations Technology Manager, The Lubrizol Corporation
This paper describes the application of an advanced model predictive adaptive controller to the problem of batch reactor temperature control. Although a great deal of work has been done to improve reactor throughput using batch sequence control, the control of the actual reactor temperature remains a difficult
problem for many operators of these processes. Temperature control on these systems is difficult for conventional Proportional-Integral-Derivative (PID) controllers because the response is characterized bynan open loop integrator with long delay and time constant. Temperature control is important as many chemical reactions are sensitive to temperature for formation of desired products and reaction rates can be highly temperature dependent. The applications discussed in this paper include a PVC reactor and an Ethoxylated fatty acid reactor. In each case, the variability of the reactor temperature was reduced by 60% or more. Improved temperature control permitted operation at higher reaction temperatures with higher sustained feed rates of reactants and catalysts while remaining within product temperature limits. Batch cycle times were reduced by as much as 35% due to the higher sustained reaction rates. The applications demonstrate the attractive economics for optimization of batch reactors with model predictive controls and highlight the opportunity for tremendous improvements in batch consistency, reduced batch cycle times, and improved productivity.
Mihai Huzmezan, University of British Columbia, Pulp and Paper Centre; Bill Gough, Sava Kovac, Universal Dynamics Technologies Inc.
Alarm and event analysis has long been used for improving process operation. However since alarms are usually generated and displayed based on physical equipment, alarm analysis has been difficult to perform on a batch basis.
In this paper, we focus on the interrelation of alarm/message notification and operator reaction in a batch process and analyze them systematically according to S88.01 Models and Terminology. Balance patterns of alarm/message notification and operator reactions are visually analyzed. Batch based analysis is done by grouping and filtering alarm and event data by master recipe, procedural hierarchy, and batch unit. This makes it easy to find and improve spurious alarms and inefficient operator habits.
In a brief experience in a pharmaceutical plant, spurious alarms have been reduced by approximately 30% and smoother operation procedures have been implemented.
Yoshitaka Yuki, Manager, Yokogawa Corporation of America; Jim Parks, Instrument Engineer, Lonza Inc.
The case study in this paper illustrates the value of integrating front-end scheduling with a batch control system. Recipe changes, and addition of recipes, occur frequently in the target process. However, since both scheduler and batch packages were designed with the ISA-S88.01 model in mind, these packages could be tightly coupled (well integrated) and, as a result, it is easy to add or change recipes. The frontend scheduler is not limited to performing scheduling; it also provides an easy-to-grasp real-time production status display which can help enhance efficiency and productivity.
Ryoichi Himono, Yokogawa Electric Corporation; Kenichi Takahata, Suntory Limited; Kiyokazu Mano, Suntory Limited
This paper describes an approach to the production of the process automation systems for large-scale pharmaceutical processes using S88.01.
The context is the development of highly automated systems concurrently with the project design engineering on a fast-track project.
A recipe control of a continuous distillation plant was a challenge in its design, simulation, validation and successful exploitation. The plant was used for solvent recovery in an Active Pharmaceutical Ingredients Production Facility (API).
Following S88 models, which were used as tools in structuring a specific process cell, which had several trains with batch operating units, it was decided to apply and extend the same approach on the continuous processes as well.
The application of Model Predictive Control (MPC) is often considered for multi-variable continuous processes. However, the benefit of applying MPC to a batch process can often be just as significant as a continuous process. In this presentation we will show how MPC is being applied in a pharmaceutical manufacturing facility for the control of one cut of a batch distillation column. The primary benefit of using MPC is to reduce batch cycle time. The performance that can be achieve with MPC vs. traditional techniques for this application will be examined.
Automating manufacturing using S88 concepts across all of the operational manufacturing boundaries has become the standard way of doing business. The current states of the technologies used in these automations require individuals with unique capabilities, or success is not always certain. Each operational area has its own unique needs, and not only requires a high minimum capability in that area, but the ability to coordinate across areas as well.
This paper will address what it takes to identify levels of capability, and the benefits of taking advantage of this capability. What to look for in evaluating an organizations capability in delivering automation will also be discussed, as well as the results of not knowing your automation suppliers real capabilities.
This paper describes an end-user project at Arla Foods with the use of the B2MML schemas as a corporate standard for communication between business systems and ES systems. This presentation presents the real-life experiences using the B2MML schemas. The focus is on the Schedule and Performance schemas. A short introduction on the general use of S88 and S95 within Arla Foods is also included.