12 FACILITY MONITORING
operation is essential to patient care and the financial well-being of the hospital — but construction
is a dirty job, and cleanroom environments must be
protected and continuously monitored.
A fully compliant compounding pharmacy
program starts with an adequate environmental
analysis and the proper design and construction of
primary engineering controls. Fortunately, advances in technology are enabling hospital pharmacy
stakeholders to achieve compliance even as their
cleanrooms undergo renovation, relocation, or a
Air decontamination units with HEPA filters
are available that offer an additional and validated
unique technology to destroy a full spectrum of airborne microorganisms. These technologies can significantly augment the effectiveness of existing cleanrooms and segregated compounding areas, as well as
serve as air quality control mechanisms in temporary
cleanrooms during pharmacy renovations.
Pharmacies must continue to build safer environments for medication preparation for both
patients and personnel. Advances in air quality
control, workflow management software, IV robotic
compounding technology, and advanced cleanroom
walls, ceilings, and flooring have shown the ability
to provide a new standard in aseptic compounding.
Consideration must also be given to cleanroom
features such as nonporous and smooth surfaces,
including walls and ceilings that can withstand
routine decontamination; proper pressure differentials between rooms, the most positive pressure
being in the aseptic processing rooms or areas; use
of unidirectional airflow in the immediate vicinity
of exposed product or components; sufficient air
change frequency; appropriate humidity and temperature environmental controls; and a documented sanitization program.
In the U.S., there are advanced technologies now
available that combine different solutions to help
control air and surface contamination in hospitals.
These technologies use advanced HEPA filtration quality and microbial destruction using cold
plasma without releasing toxic compounds (air
decontamination) and/or filtration technology
to diffuse a dry and cold hydrogen peroxide and
peracetic acid solution to destroy bacteria, spores,
fungi and yeasts, viruses, and mycobacteria, including tubercle bacillus, the myobacterium that causes
tuberculosis (surface decontamination).
In addition to careful consideration of filtration
and decontamination technology, stakeholders
should select suppliers, architects, and consultants
as they plan new cleanroom environments and/or
pharmacy renovations to achieve USP <797> and
USP <800> compliance.
Workflow analysis, facility assessments, gap
analyses, and reviews of pharmacy operations that
include USP <797> and USP <800> survey feedback and analysis report are needed.
Design and installation of advanced monitoring
systems for control of non-viable particle count,
temperature, humidity, and pressure are also highly
Experts in cleanroom floor plan and ceiling
design, cleanroom air balance analysis, including required Cubic Feet per Minute (CFM) per
room (supply/return/exhaust), Air Changes per
Hour (ACH) per room, and other environmental
requirements should be employed. Guidance and
support to help ensure certification and compliance, structural calculations, and drawings needed for Office of Statewide Health Planning and
Development (OSHPD) submissions are invaluable.
Because continued operation of cleanrooms in
hospital pharmacies is essential, even during renovation and construction activities, companies with
the adequate expertise and technologies to enable
the use of advanced systems that can significantly
augment the effectiveness of existing cleanrooms
and segregated compounding areas, as well as
serve as air quality control mechanisms to create
fully compliant and financially affordable temporary cleanrooms during pharmacy renovations are
essential to staff and patient safety, product quality,
and operational efficiencies.
Kim Zurawski began a 30-year career in healthcare
marketing in hospital planning at Steris Corp. She has
held strategic and product management leadership positions in large, publicly-traded corporations and small,
early stage privately-funded enterprises. She has worked
for Grifols for two years.
Juan Miguel Cana Lopez has developed and
deployed products, created marketing and sales strategies and provided business leadership in both the U.S.
and Europe. Juan started his career with Grifols in 1991.
In 1999, he moved to Barcelona to become the country
leader of the Hospital Logistics Sales Division. In 2009,
Juan moved to the U.S. to lead the newly created Grifols
Hospital Division business unit in the North American