Unit operations in modules applied in nutraceutical manufacturing. (Hecht
From a technical perspective, there are two main drivers
for modular design and construction in pharmaceutical process facilities:
1. Breaking down the facility and the manufacturing processes
into functional building blocks/modules creates opportunities to simplify, standardize, verify, and re-use designs as
well as actual modules in different implementations.
2. Breaking down the facility and the manufacturing processes into physical building blocks/modules creates
opportunities to build the modules off-site, typically in
a factory specifically designed for this purpose. This reduces congestion and disturbances on site, while increasing quality and efficiency when the modules are built by
skilled labor under controlled conditions. As modules can
be built in parallel with site infrastructure, significant time
savings can also be achieved.
These drivers are parallel and in well-executed projects
modularization is used to address both. The right combination has the potential to reduce cost and schedule while
increasing flexibility of the completed facility.
TECHNOLOGICAL AND MARKET TRENDS
The term “Modular” is interpreted in many different ways.
As modular concepts are gaining acceptance in the pharma-
ceutical industry, the trend towards modular can be broken
down into several concepts at different functional and physi-
cal levels including:
• “Plug-and Play” re-configurable systems. This concept
is widely used in the IT industry where both hard- and
software are made up by a (sometimes large) number of
modules that can be configured in different ways without
changing the individual modules. In the pharmaceutical in-
dustry, C-SOPS (Engineering Research Center for Structural
Organics Particulate Systems) is developing configurations
for continuous manufacturing of pharmaceutical products.
One of the goals of the project is to be able to define in-
terfaces between different process steps clearly enough to
allow for switching between different machines for certain
unit operations while keeping the overall functionality of
the system and other unit operations unchanged.
• Modular unit operations where a complete function is integrated in one or more modules to be placed in an existing
clean room suite. This is not a new concept, but is being
utilized in more applications and continuously gaining increased acceptance.
• Self-contained unit operations that segregate each unit
operation into individual modules to hold the operation.
These modules are designed to be placed in an open con-trolled-not-classified (CNC) open space and each module
provides its own clean-room environment for the process.
An example of this type of modules is GE’s Xcellerex line
• Individual clean-room modules. In this concept, each clean-room module comes complete with air handling and distribution systems and is intended to dock to e.g. a clean-room
corridor in order to connect to additional modules. The
best known example of this type of implementation is at
Texas A&M University, which includes clean room modules
from G-Con and Walker Barrier Systems.
• Integrated clean-room suites for a complete manufacturing
step, e.g. weighing and dispensing, mixing, granulation and
drying, biologics bulk manufacturing and sterile filling.
These suites can be stand-alone or combined to a complete manufacturing facility that can be installed in a site-built shell building or be a stand-alone building. Examples
of these suites include KeyPlants/Telstar’s MAS (Modular
Aseptic Solutions ™) and MBS (Modular Bio Solutions),
GE’s KUBio, and Lödige/Mod Wave’s modular suites for
continuous processing of small molecule products.
The above-mentioned modular concepts can be combined
in different ways to best suit each application. Their acceptance varies significantly within the pharmaceutical industry.
Some companies are still primarily utilizing traditional con-
Flexible, modular pharmaceutical continuous processing suite. (Gebrüder
Lödige, GmbH and Mod Wave LLC)