PharmTech: 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.
PharmTech: 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.
Implementing single-use systems in traditional stainless-steel facilities
PharmTech: What are some of the advantages of implementing single-use systems?
Odum (IPS): Advantages include reduction of cleaning costs via the decrease in the size or elimination of costly clean-in-place (CIP)
systems because you are now getting away from fixed stainless steel equipment. Along that same line, there can be a reduction
in floor space because equipment is smaller and easier to move in equipment modules. Work is being done to consider how the
implementation of single-use systems can reduce the amount of classified space that you must maintain during your manufacturing
operations, via validation of system closure. Perhaps the biggest advantage of single-use systems is flexibility, especially
if you are looking at the issues related to process changes in early-stage development.
Many developments in the biopharmaceutical industry have added to the challenges of designing, building, and operating the
traditional manufacturing facilities that we've used over the past three decades. As our insights into product requirements
and product characterization increase, the critical path for the development of many new products is now shifting to the
process development stage, and manufacturing timelines are being condensed. Speed and flexibility are thus becoming crucial
to many of our clients.
Future manufacturing systems must be agile enough to deliver on this flexibility with regards to a wider variety of product
types and in a shorter timeframe. Single-use systems can provide a means to allow for this increased flexibility and a focus
on speed to market, even if you are dealing with a stainless steel-based facility.