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The Human Factor in Facility Design innovation

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The Human Factor in
Facility Design innovation
by lawrence DiGennaro




B
         ioprocess and pharmaceutical           an open space plan that optimizes
         production environments must           flexibility and teamwork with point-
         be well designed to meet strict        of-use isolator technology to control
         cleanroom and quality                  cross-contamination. Such a plan can
assurance (QA) standards and                    liberate a production room and its
productivity requirements. Managers             personnel from as many environmental
may also consider innovative ways to            parameters as possible.
enhance the design of these
environments to enable the people               Face-to-Face Meeting SpaceS
critical to their companies’ success to         Consider the typical flow of people
be more productive and effective. In            into a bioprocess or pharmaceutical
today’s work culture, countless hours           manufacturing facility. Often there
can be lost to poor teamwork and                are separate entry points: one for
ineffective communication. CGMP                 production employees and contractors
environments present additional,                and the other for nonproduction
unique challenges to human                      employees and visitors. Each group
interaction because of their built-in           must pass through a central
process and protocol barriers.                  checkpoint — with its reception desk,
                                                                                                  Digitalvision (www.gettyimages.com)
   Effective space planning and design          photo-ID and badging station, and
alone cannot create a culture of                often, uniformed security officers. To
                                                                                            want to use the restroom, eat lunch,
teamwork, but a lack of the right kind          keep from impeding the flow of
                                                                                            meet with a nonproduction employee,
of space can inhibit it. Providing the          employees into a production facility,
                                                                                            or fill out a timesheet.
right building blocks creates a place           care must be taken at this point to
                                                                                               Imagine the barrier that time
where a culture of teamwork can be              separate them from visitors.
                                                                                            commitment creates to effective
developed: design of the right kind of              Production employees progress
                                                                                            collaboration and teamwork. Surely
space, staff training on how to use             directly to a locker room, where they
                                                                                            issues arise every day that could be
that space effectively, and                     pick up their plant uniforms and begin
                                                                                            resolved with a simple five-minute
management support of productive                the gowning process. A significant
                                                                                            face-to-face conversation. What if key
teamwork concepts.                              communication barrier occurs at the
                                                                                            production personnel could meet face-
   Three key design strategies can              subsequent gowning portal, where a
                                                                                            to-face in the production floor without
help create this type of environment.           production employee puts on a gown
                                                                                            needing to take the time to completely
One is to design spaces that enable             and hair covering over the plant
                                                                                            degown? What if nonproduction
face-to-face communication among                uniform and passes a step-over bench,
                                                                                            personnel could occasionally meet
staff without complete degowning or             adding shoe covers or changing to
                                                                                            their production counterparts within
violating cleanroom standards.                  captured shoes. The gowning process
                                                                                            their own territory, thus sharing the
Another is to improve visibility within         is time-consuming, often taking 10
                                                                                            time commitment associated with
and into process areas to enhance               minutes or more, each time an
                                                                                            gowning? This can be accomplished
safety, productivity, and marketing             employee enters or reenters the facility.
                                                                                            by creating a small meeting space
efforts. A third strategy pushes the            So CGMP production employees must
                                                                                            within the larger cleanroom
design envelope even further, creating          commit 10 minutes every time they
                                                                                            environment.
22   BioProcess International   December 2010
    Facility designers may consider             Figure 1: typical cgmP production facility flow diagram
designing each production block with




                                                                                                           n
a “court” that could be accessed                                       Production




                                                                                                        sI




                                                                                       Co ut In
                                                                                              Ou at’l
                                                                      Employees and




                                                                                            h vice
through the CGMP corridor (Figure




                                                                                                      n
                                                                                              er rs,
                                                                                         as , M




                                                                                                   sI
                                                                                          liv cto
                                                                       Contractors




                                                                                                 t




                                                                                                ie
                                                                                       Tr Ser
                                                                                       Tr lies
1). About 30 ft 2 could contain CGMP




                                                                                              O

                                                                                        De ra
                                                                                          pp




                                                                                          od
                                                                                            h




                                                                                          nt
                                                                                         as
clean space, a gowning area, and a




                                                                                      Su




                                                                                       Fo
                                                Employees, Visitors
                                                 Nonproduction
non-CGMP space (Figure 2).
    The first level of spaces within the                                Security       O ce   Cafe      Tech         Lab
court would meet a facility’s CGMP
cleanroom standard. It might include




                                                                                                                                          e
                                                                                                                                        us
a “huddle room,” where two




                                                                                                                                       o
                                                                                                                                    eh
                                                                            Non-GMP




                                                                                                                                  ar
production employees could meet in




                                                                                                                                 W
                                                                            Corridor          Uniform      Lockers
full gown and/or access a CGMP
workstation (with no fabric or wood
surfaces) to fill out a time sheet, write                                                                 Gowning
notes, or check e-mail.
    To access the non-CGMP space,                                           GMP Corridor




                                                                                                                                        g
production employees would first




                                                                                                                                        n
                                                                                                                                     gi
                                                                                                                                   ka
enter a degowning area with a step-                                          “Court”                  “Court”




                                                                                                                                    c
                                                                                                                                 Pa
over bench. Here they would hang up
their protective garments and put
protective covers over their shoes.
Then they could access a break room
to relax and drink water as well as
                                                within a production environment                      Figure 2: “court” diagram
conference rooms where they could
                                                could act as space “shock absorbers”
meet with nonproduction staff.                                                                                      GMP Corridor
                                                when production demands increase.
Standard computer workstations
                                                Over time, they could actually be
would provide them with
                                                repurposed, facilitating the
opportunities to analyze data or write
                                                incremental growth of production
reports. Such an area could not only                                                                       GMP
                                                equipment, with new courts added                                                    GMP
reduce regowning times when                                                                               Huddle                   Wkstn.
                                                during the next full capital expansion.
production employees need to meet
with one another or access a computer
                                                tranSparent
workstation, it also could improve
                                                production proceSSeS                                                  Degown
communication between production
                                                A second design strategy improves
staff and their office colleagues.
                                                visibility within and into process areas
    Some companies don’t want to
                                                to enhance safety, productivity, and
include this type of inexpensive
                                                marketing efforts. Typically,
“office” space within a valuable
                                                production lines are separated by solid
production environment. But how
                                                walls to minimize the chance of cross                      Work-       Conf.        Break
much value could be added to a                                                                            station      Room         Room
                                                contamination. Such designs limit
bioprocess if employees could be more
                                                sight lines both on the production
productive? The answer to that
                                                floor and between it and the rest of a
question is often dismissed because it
                                                facility. Smaller compartments also
is much easier to quantify the return
                                                tend to drive staffing decisions.                       Improving sight lines into and within
on investment (ROI) for process
                                                Managers tend to put people in each                  a cleanroom also improves efficiency
technology than for people. If we buy
                                                individual space even when the process               and decreases the risk of contamination
a larger but more expensive bioreactor
                                                in that space doesn’t require staff.                 by reducing the need to enter it for
that can produce higher cell culture
                                                    It’s possible to create greater                  routine purposes (e.g., to find a certain
yields, the return is easy to measure. It
                                                visibility, both for safety and marketing            staff member). This may also shorten
is harder to quantify the results of
                                                purposes, while simultaneously                       response times during unexpected
investing in people. So how often do
                                                minimizing facility-imposed staffing                 incidents. And it enables companies to
production needs grow just enough to
                                                barriers. These spaces can be visually               offer tours to potential collaborators
require more space, but not enough to
                                                opened up by using observation                       and/or clients without requiring them to
justify a large capital expenditure?
                                                windows or creating an elevated area                 go through the gowning process,
The answer to that question may
                                                above the production suite that provides             exposing them to possible hazards, or
make investment in courts easier to
                                                direct view of the production floor.                 disrupting activity on the production
understand. Strategically placed courts
24   BioProcess International   December 2010
floor. More important, communication             process technology — first requires a       provide meeting spaces within a
and teamwork can increase with a                 thorough understanding of how people        cleanroom environment, increase use
descreased need for contamination                work within it. Only then can a             of glazing into and on the process
protocols.                                       designer create a space that enables the    floor, or use windows/skylights to
                                                 most productive working relationship        provide natural lighting. Point-of-use
iSolator technology approach                     among team members and their                isolator technology pushes the
Production rooms and personnel can               processing technology. Simply put, a        envelope even further. Innovations are
be completely liberated from many                successful outcome requires integration     not without their costs and risks. But
environmental parameters in an open              of people, process, and design.             if we design our facilities only to meet
space plan that optimizes processes                                                          cleanroom and QA/QC standards




                                                     •
using point-of-use isolator technology                                                       without considering the human factor,
to control cross-contamination. A case                                                       then we have missed opportunities to
in point is Coldstream Laboratories. A                                                       enable the people who are critical to
20,000-ft 2 sterile manufacturing                                                            their success to be as productive and
facility is located on the company’s                                                         effective as they can be. And as in any
Coldstream Research Campus in                               Product cross-                   other industry, productive and
Lexington, KY.                                                                               effective people can provide a
                                                            contamination is
   Its business model was developed                                                          competitive edge in bioprocessing.
for production of sterile parenteral                        significantly
clinical supplies and low-volume,                           reDUCeD with                     reFerence
high-potency niche commercial                               isolator technology.                  1 Romm JJ, Browning WD. Greening the
                                                                                             Building and the Bottom Line. Rocky
products. The plant uses isolator
                                                                                             Mountain Institute: www.rmi.org/rmi/Library/
technology to control cross-                                                                 D94-27_GreeningBuildingBottomLine
contamination in a manner that could                                                              2 Figueiro MG, et al. Daylight and
change how space supports                                                                    Productivity: A Field Study. European Council
biomanufacturing processes. The                  light, Security, productivity               for an Energy Efficient Economy: 6–11 June
technology enables operators to handle           Research by the Rocky Mountain              2011; www.eceee.org/conference_proceedings/
                                                                                             ACEEE_buildings/2002/Panel_8/p8_6.
sterile, potent, cytotoxic, and                  Institute and the Lighting Research
radiolabeled products in a contained             Center of Rensselaer Polytechnic
box that functions both as a barrier to          Institute has shown that natural light      Further reading
protect product streams from                     contributes to human health,                    Galliher P. Achieving High-Efficiency
                                                                                             Production with Microbial Technology in a
contamination and operators from                 productivity, and safety while
                                                                                             6(11) 2008: 60–65. •
                                                                                             Single-Use Bioreactor Platform. BioProcess Int.
exposure. As the industry moves                  decreasing overall building energy
toward low-volume, high-changeover               usage (1, 2). Ideally, a bioprocess floor
products, this provides great                    would include skylights or clerestory       Lawrence DiGennaro, AIA, is the science
opportunities for flexibility in a               windows to bring natural light into a       market leader for BHDP Architecture,
biomanufacturing environment. And                facility. A facility design must be         302 West Third Street, Suite 500, Cincinnati,
liberating or minimizing the                     responsive to issues of security as well    OH 45202; 1-513-527-0243; ldigennaro@
constraints of elaborate gowning                 as cleanroom and quality control (QC)       bhdp.com. A member of the International
protocols on people may both improve             standards. However, many industries         Society for Pharmaceutical Engineering , he
the quality of their work environment            for which security is paramount have        manages the planning, programming, and
and allow more effective teamwork.               successfully increased the penetration      design of projects for both the public and
   The system is a change from                   of natural light using such windows         private sectors, including academic and
cellular production facilities in the            and/or skylights manufactured with          government institutions and
                                                                                             pharmaceutical companies.
past, and with change comes risk.                security glazing such as polycarbonate
Managers ask whether the potential               or glass-clad polycarbonate.
benefits of better teamwork and                     For example, in a project for a           To order reprints of this article,
                                                                                              contact Carmelita Garland (carmelitag@
increased flexibility are worth that             highly secure research facility, our firm
                                                                                              fosterprinting.com) at 1-800-382-0808,
risk. So don’t forget that product               used a Kalwall Corp. system (www.            ext. 154. Download a low-resolution PDF
cross-contamination is significantly             kalwall.com) with insulated, diffuse,        at www.bioprocessintl.com.
reduced with isolator technology.                light-transmitting, structural composite
   Designing a building that enables             sandwich panels to cover the windows.
production personnel to work                     That made it possible to achieve a
efficiently and effectively with isolator        sound transmission class (STC) rating
technology is not a matter of simply             of 45, “faint to moderate.”
providing large, column-free spaces.                All design innovations require
Effective design for such an approach            investment and have associated risks
— and for that matter, any type of               and benefits. Not every project can
26   BioProcess International    December 2010

				
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