Automation projects

Economic Incentives for Automation Projects Industrial applications of advanced process control strategies such as MFC are... 

FIG. 8-42 Economic incentives for automation projects in the process industries. 

Laboratory automation in pharmaceutical analysis attained maturity since robots first appeared in pharmaceutical laboratories more than 20 years ago. While automation offers great promise for improving sample throughput and reducing sample backlog, its implementation has not been without problems. The industry cannot invest heavily in tools that produce little return on investment. Strategies in key aspects of automation such as planning, vendor selection, personnel, and efficient use of systems can determine the success or failure of an automation project. 

The individual user is one of the major considerations. The input of those who will use the system day-in and day-out is critical to the design. The role of the user in the design will vary based on the specifics of the automation project. In the case where the system will be customized, the user must have input on almost every aspect. This will allow the resulting method to approximate the manual or current approach as closely as possible. Off the shelf systems (semi and fully automated) likewise are very dependent upon user input however, a careful balancing act has to be performed. Our... 

Economic Incentives for Automation Projects Industrial applications of advanced process control strategies such as MPC are motivated by the need for improvements regarding safety, product quality, environmental standards, and economic operation of the process. One view of the economics incentives for advanced automation techniques is illustrated in Fig. 8-41. Distributed control systems (DCS) are widely used for data acquisition and conventional singleloop (PID) control. The addition of advanced regulatory control systems such as selective controls, gain scheduling, and time-delay compensation can provide benefits for a modest incremental cost. But... 

Before the final decision is taken on the direction of an automation project, the following questions should be asked in the laboratory ... 

Laboratory automation is, in itself not a goal, but, rather a means of achieving an objective anJ a process for solving some laboratory problems. That process involves a substantial planning effort. Without adequate planning, a laboratory automation project may generate more problems than it solves. 

Eventually, in any lab automation project, you come to the same decision point do I purchase a system, or have one built to my rparticular, unique, special, one of a kindl - fill in the blank - needs First, are your needs really that [particular, unique, special, one of a kindl A consultant can help you find out. If they are, you choice is clear. If they aren t you have some thinking to do. 

Properly planned, a laboratory automation project can improve a labs ability to collect, analyze, and manage data. That planning needs to begin early in a labs lifetime, and should include a consideration of long term and short term goals. With that work in place, you have greatly improved the likelihood of a successful automation project. 

Getting an application to work the first time This is the aim of most automation projects, and the validation process assists in fulfilling this objective. Failure will have significant cost penalties in lost production output. 

Robert Fretz joined F. Hoffmann-Fa Roche more than 30 years ago as a chemical engineer. He is presently responsible for Process Automation in all chemical and galenical manufacturing sites and leads the corporate Mamrfacturing Execution systems program. Mr. Fretz has broad international experience in all levels of control/automation projects from instrumentation to the enterprise level. Many of these projects included computerized system validation. He co-authored the Hoffmann-Fa Roche corporate guideline on Process Automation Qualification. 

Not every laboratory automation project has been successful. The authors believe that the poorer than expected results for at least some of those projects were due to inadequate planning and lack of evaluation of requirements. Box 11-3 lists 10 potential reasons why automation fails to meet expectations. 

It is useful to understand the steps of the software development life cycle (SDLC) during a project. In fact, this approach is commonly used for implementation and validation even when commercial off-the-shelf software is involved [104]. It is also important to consider the economic aspects of the automation project [105]. A 10-step guide to success that emphasizes clearly defined project control in outsourced automation/information technology projects has been published [106]. 

American Pharmaceutical Association Animal and Plant Health Inspection Service Acceptable quality level AIDS-related complex Adult respiratory distress syndrome Applied Research Ethics National Association American Statistical Association Administrative Systems Automation Project (FDA)... 

Before beginning the discussion of how to implement an automation project, it is helpful to first look at an example of what can go wrong. This example is all too familiar A laboratory manager decides to increase the use of automation tools. A scientist is asked to automate LBAs. After meeting with several vendors, a system is chosen and purchased with only a vague idea of how it will actually function. The system is very expensive and the vendor seems very responsive, so everyone assumes that they are on the right track. The system is installed in the lab and a couple of lab personnel (whose education, experience, and aptitude are in biochemistry, not in... 

Although this is obviously an extreme example, every company has encountered at least one of these obstacles and many first automation projects end up running into many of these roadblocks. The root causes of the above problems can be summarized as follows ... 

To avoid these problems, an automation project must be planned and executed in an orderly manner. A GLP automation project can be broken down into the following general phases ... 

Defining a Problem Statement The first step in successfully implementing an automation project is to clearly define the problem that needs to be solved. Automation can solve a number of different problems. Each laboratory must ask itself which specific problems it wants to solve. The best place to start is in thinking about the needs of the laboratory. Is there a need to analyze more samples with fewer people or to shorten sample turnaround time Is there a need to increase the consistency of an assay or process Is there a need to reduce exposure to hazardous materials or to minimize operator fatigue or repetitive motion injuries Is there a need to reduce the cost per sample Is there a need for a process to run overnight or over the weekend ... 

The answers to these and other questions determine the approach that will be taken at every subsequent stage of the project, so it is critical that sufficient attention is given to this step [5,6]. For aftrst automation project, it is recommended to choose one or two primary goals. Once the system is successfully implemented, work can begin on the others. If a laboratory already has a solid track record with automation, then it may be appropriate to set a loftier goal. 

Most laboratory managers will have an intuitive sense of which problems need attention. Nevertheless, it is a good idea to solicit feedback from other members of the laboratory, if for no other reason than to give people at all levels in the organization a common understanding of what is needed. It is recommended to document this problem statement so that it will be clear in the future what the goal is. Note that at this point it is not necessarily an automation project it is only a problem statement. In the... 

Next consider various solutions to the problem. Is there a simple process change that would help to solve the problem Are there multiple bottlenecks that must be removed Are the benefits of solving a particular problem worth the cost Now that the problem is better understood, is this still the problem that requires the most attention Finally, is this a problem that automation could solve If the answer to the last question is yes, then an automation project can begin with a well-defined goal. 

Forming a Project Team The next step in implementing an automation project is to form aproject team. Depending on the size and scope of the project as well as the laboratory s resources, the project team could consist of as few as one person to as many as five or six. The key requirements are that the team has sufficient skills and sufficient time to implement the project. The core skills for an automation project are as follows ... 

The example in Table 11.1 shows how the process of creating the use case raised a number of relevant questions about the system. This may seem like a lot of work for an off-the-shelf system, but the questions raised by this use case are exactly the issues that delay automation projects. While there are other, less formal ways of getting at this information that may work fine, the key point is to spend some time thinking about what is required of the system and to document the process. If insufficient thought is given to what is required, there is no guarantee the system will meet the laboratory s requirements. 

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