The Need for Flexible Facility Designs

Currently the need of a paradigm shift in the facility design of pharmaceutical and
biopharmaceutical production sites has been stated in multiple papers and conferences (1, 2, 3).
The reasons for such facility layout changes are manifold and, for example, can be newly
evolving drug developments, changes in process technologies, transformation of the treatment or patient base or purely economic reasons, which focus on capacity utilization and process flexibilities. Ultimately, there is a change process happening, a shift from large area, product dedicated brick and mortar facilities to more versatile but multiple facilities in different regions.
With that new demand by the industry comes the promise of the delivery of the expected, in the form of “flexible facilities”, “modular facilities” or ”manufacturing on demand”. This article will review “the tools in the toolbox” of facility designs, especially ones labeled modular or flexible or both. A serious review of the promises and statements made might be of value.
What’s out there?
Besides the traditional brick and mortar facilities, there are alternative facility designs available, for example, modular container, modular stick-built, isolator or containment based and autonomous cleanroom POD designs (Table 1). All of these designs have their purpose, benefits and disadvantages (Table 2). Often these designs are utilized in a hybrid mode and not necessarily totally independent. Once again any of these facility designs are a tool in the toolbox of choices for the drug manufacturer or the engineering firms supporting such. The very specific choices, which need to be made, are requirement based. What is the purpose of the facility, what are the requirements to fulfill the purpose? Ultimately it boils down to the particular need of the application and end-user.
Facility Design Description
Bricks & Mortar
The traditional type facility, build often for one product and large scale. Lifespan of
the facility is commonly one product lifecycle. Very dedicated and purpose-build
facility design. HVAC systems in the mezzanine level supply large areas.
Modular Container
Off-site build container systems, which are interconnected at the final location to a
complete facility. The container modules can be outfitted and designed to purpose.
Centralized HVAC system.
Stick-built Modular
The facility is framed out and finished with modular wall panels. The wall panels can
be of different surface finish or designs to accommodate for example room-to-room
pass through or windows. HVAC systems in the mezzanine level supplying multiple
rooms. Isolator or Controlled Build off-site and most commonly introduced into either a cleanroom or at least CNC  Environment Module area. Depending on the system, it creates an excellent containment option and can be repurposed and effortlessly sanitized. Some systems are connected to a centralized HVAC system, others might have their own.
Autonomous POD
Off-site build autonomous cleanroom module. Available in various standard
dimension, but can be modified into project designs. Effortlessly sanitized and
decontaminated. The PODs are mobile and contain their own HVAC system.
Table 1: Description of the different facility designs available.
A decision matrix will determine, which one of the tools shall be utilized for the project and/or for a section of the project. As mentioned, a facility may not necessarily be designed with one of the facility options, but often resolves into a hybrid solution of two or three of the options listed.
For example, cell therapeutic or antibody conjugate processing happens often in production isolators or other containment options, which are surrounded by a class B environment, which can be any type of cleanroom. Autonomous cleanroom POD solutions are most commonly connected to a stick-built corridor system. It is not that there is a one-fits-all approach, which makes a modern facility more viable, it is the approach to pick and chose the right design solutions for an optimal fulfillment of the specified purposes. This approach has been utilized for many years in the design of the production processes. End-users moved away from the legacy models to evaluation of the best process equipment choice for a particular unit operation, even if it means multiple vendor use.
Facility Design Strength Weakness
Bricks & Mortar
• Extensive experience level
with such facilities
• Dedicated product
• Large areas
• Time-to-run 24-48 months
• Difficult to repurpose
• One product lifecycle
• High CAPEX
• Up to 4 years time-to-run
• Inflexible
• Large HVAC superstructure
• Difficult to decontaminate if
Modular Container
• CAPEX 70-90%of traditional
• Time-to-run 18-24 months
• Off-site build-up
• Interconnected to one large
facility losing its flexibility at that
• Large HVAC superstructure
• Shipping costs
• Not scalable
Stick-built Modular
• CAPEX 50% lower than
traditional built
• Time-to-run 6-24 months
• Build into a shell building
• Potentially scalable
• Interconnected to one large
facility losing its flexibility at that
• Large HVAC superstructure
• On-site build-up
Isolator or Controlled • CAPEX 50% lower than
traditional built
• Size limitations make the use of
larger equipment difficult
Environment Module • Time-to-run 12-18 months
• Modules are repurposable
• Possible to decontaminate
• Scalable
• BSL containment limitations
• Centralized HVAC
Autonomous POD
• CAPEX 40-50%of traditional
• Time-to-run 6-18 months
• Moved into a shell building
• PODs are repurposable
• Easy to decontaminate
• Redundant HVAC system in
each POD
• Scalable
• Shipping costs
• Equipment size excursions
require project POD
Table 2 – Strength and weakness analysis of the different facility designs available.
What does flexible mean ?
First of all one probably should …..
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