Modular process suite with mechanical second floor – being built in the
factory (top) and rolled into a warehouse building at the Owner’s site (
bottom) (KeyPlants AB)
long time synonymous with the modular process buildings pioneered by Pharmadule AB of Sweden (who ceased operation
in February 2011). Pharmadule’s modular system was characterized by a building made up of a number of modules, with
the process implemented in a way that the building modules
could easily be disassembled, with installations remaining in
place, for transport and reassembly at the owner’s site. The
concept of modular buildings for pharmaceutical manufacturing has evolved significantly in the last few years.
In parallel with the development and implementation of
modular facilities for pharmaceutical production, manufacturers of process equipment for pharmaceutical (and biopharmaceutical) production are offering more complete and
self-contained systems and processes. We are now seeing a
trend towards combination and integration of these concepts
into a variety of hybrid systems.
FLEXIBLE MODULAR AND HYBRID CONCEPTS
The early modular buildings generally offered significant
time savings and quality advantages over traditionally executed projects. Once completed, however, these modular
buildings where often considered difficult to reconfigure
once they where built, much due to the way HVAC installations were integrated in the buildings and extensive use of
interior steel walls. Recent designs instead use flexible wall
systems, an open architecture where HVAC systems are accessed from mechanical areas and easily reconfigured, and
modular thinking down to the process designs and components used. This allows for concepts that are flexible in design, implementation, operation and future reconfiguration.
As pharmaceutical and biopharmaceutical com- panies adopt to a global and highly competitive market, the way production facilities are being designed and built is changing significantly.
Rather than building mega-facilities to supply a large portion of the total market for decades to come, the focus is
increasingly on rapid deployment of flexible facilities to serve
regional markets, at a significantly lower cost than in the past.
Modular and flexible facilities are concepts that can support these goals without sacrificing quality and compliance.
“Modular” and “Flexible” are however not synonymous as we
can sometimes be led to believe when reading articles and marketing material about these concepts. Modular implementation
has the potential to significantly reduce time to completion,
increase flexibility and lower risk, while ensuring quality and
predictability in project implementation – when used right.
This article discusses some of the latest trends and technologies in modular and flexible facilities for the pharmaceutical and biopharmaceutical industries, including some of the
challenges facing teams working on these projects.
The term “Modular” refers to the division of functions into
clearly defined, scalable and reusable functional elements.
These modules or objects have rigorously defined interfaces
and functionality and are used as building blocks for complete systems.
In the pharmaceutical industry, modular facilities were for a
■ By Pär Almhem, President, ModWave
Helping pharma manufacturers adapt to changing market conditions