The conference schedule at INTERPHEX 2013 covered a wide range of topics, including facility and process design. BioPharm International interviewed Craig Sandstrom, director of process engineering at Fluor; Par Almhem, president of ModWave and Modular Partners; and Jeff Odum, director of operations at IPS–Integrated Project Services, to gain their perspectives on trends in facility and process design.
Modularization has been used by other industries for decades and, over the past few years, has been more accepted by the bio/pharmaceutical industry. Modularization is fast becoming an essential component of bio/pharmaceutical facility design. Use of modularization is growing because it meets the industry needs for reduced cost, accelerated construction schedules, and quality construction.BioPharm: What are some of the considerations for using modularization?
Sandstrom (Fluor): Typically people have certain cost, schedule, and quality goals for their projects. Early on in a project, an effort is undertaken to look at the site and region where the facility will be constructed and also the facility design itself to determine what opportunities exist to address these cost, schedule, and quality issues.
Some of the local or regional issues include labor availability, labor rates, and associated logistics, such as what the site has in terms of being able to get people and materials to the site. Limitations in this area may drive a desire to try to move some of those activities offsite.
In addition, there is a desire to accelerate schedules. People want to make decisions and capital commitments as late as possible to save money and also to meet product demand, which causes project schedules to be increasingly compressed. One of the ways to address compressed schedules is via modularization. Modularization allows you to parallel path many of your activities, such as process-piping and equipment construction, and in parallel with some of the activities that take place to erect the building shell.
Finally, there are quality issues. Some places that you may want to build may not have quality labor resources available, or the weather or site conditions may be prohibitive. Moving the construction offsite allows you to do your construction in a better-controlled environment with higher-skilled labor.
BioPharm: What is involved in standardization of modular unit operations?
Almhem (Modular Partners): A module, in itself, is intended to be standardized. A module has a defined function with defined inputs and outputs. Once you identify a part of the process as a clear function with a clear input and output, you can design and build that as one unit. You can combine these units in different ways to create a variety of systems from a limited number of building blocks, which are the module units or unit operations. One example is a mixing skid, with the mixing system and controls all in one module.
BioPharm: What types of modules are used in pharmaceutical production?
Sandstrom (Fluor): One common type is the building module, in which all the architectural features, equipment, and piping are preinstalled. Another commonly used concept is the tank-array module, which may include several different process-unit operations in one module. There are many other varieties of modules. In piping-specific modules, for example, you modularize just the equipment, such as a pipe rack or a large cluster of instrumentation.
BioPharm: What do you see as the future of modular manufacturing?
Sandstrom (Fluor): I see modularization as an essential component of almost all facility designs. We see it now, and we see the trend continuing in the future.
One driver is that as facilities increasingly move to more remote locations, such as in Asia or South America where local trades aren't as mature as they are in the US and Europe, there's a desire to modularize to get the hygienic components of the facility designed and fabricated in a controlled-quality location.
Almhem (Modular Partners): Modularization doesn't actually change the manufacturing itself; it's more about how you manufacture. Modules will be used as the building blocks for more and more processes simply because it's a more efficient way of building a process function, or indeed building almost anything. Nobody would consider building a software system any other way than using modules (or objects as they are called in software), for example. We will see more and more modular systems and modular pieces in pharmaceutical and biotechnology facilities and processes.