Figure 1: Podular cleanroom structure with independent air handling system
being technology, but also economical benefits.
Having said this, in instances single-use technology and the
reiteration of being a closed system may create overconfidence,
so much that calls for lower classification cleanroom or ballroom design cleanrooms space are voiced. It goes so far that a
statement was made; “one can run such single-use closed process within a garage environment”. Questions arise, why hard
piped stainless steel systems cannot be classified as closed
and what happens when there is a leak in one of the single-use
components. It would be advisable to perform a risk assessment before one rushes into the supposed cost savings of lower
cleanroom classification and lesser personnel needs, as one
batch loss or production stop may eradicate all the savings and
more. The argument of integrity testing of single-use equipment
will prevent such adverse events may be extended, however
the integrity tests evaluated so far are merely quantitative and
may not determine minute material weaknesses.
Moreover, process flexibility should not be mixed up with
facility flexibility. Yes single-use technology may promote a ballroom or lower cleanroom classification approach, though that
does not make a facility agile and flexible, but just supports a
part of the need.
AGILITY AND FLEXIBILITY
One can dive into the dictionary to find the definitions of
these two terms, but for the biopharmaceutical industry these
• Capacity scalability (up and down)
• Multi-product production
• Short time-to-run or rapid deployment
Agile and flexible facilities are now being publicized as read-
ily available. However, the word facilities is often mixed-up with
processes and single-use process technology being introduced
as flexible facilities. Processes and facility designs are inter-
linked, though should not be mixed up. A single-use technology
process is not necessarily a flexible facility.
Furthermore, modular facility designs, either as wall paneled
system, container based or prefabricated stick-build systems
are often promoted as flexible ( 4). The question one requires to
post, what does flexible mean? Faster build-up of the cleanroom
infrastructure? That would probably only justify a lesser portion of the real meaning of flexibility ( 5, 6).
The paper disseminates how agile and flexible facilities may
be defined and how these facilities can be achieved.
FLEXIBILITY AND SINGLE-USE TECHNOLOGY
It is well understood that single-use technologies can make
process and unit operations more flexible ( 7, 8). The typical
rigidity of hard piped, stainless steel laden processes, with its
lengthy turnover times is removed and replaced with disposable process equipment. That disposability not only allows
faster turnaround to re-use the process, due to avoiding lengthy
cleaning and steaming cycles, but also creates the possibility
to use the same production space for different products. The
introduction of single-use unit operations augmented that
concept, as these closed systems could be connected to each
other without breaching the aseptic barrier. Single-use process
systems create processing flexibility as the volumes processed
can be changed due to the different single-use configurations
and potentially multi-products can be processed, since the processing equipment is not re-used, but discarded after use. The
benefits have been pointed out in multiple publications, not just
■ By Maik W. Jornitz, COO G-CON Manufacturing Inc.
How podular facilities may answer it
The Call for Agile, Flexible