8 STANDARDS AND PROCEDURES
Solid-State Refrigeration
According to the Centers for Disease Control and Prevention (CDC), close to 8 million healthcare employees in the U.S. alone are potentially exposed to hazardous drugs
(HDs) every year.1 When improperly managed,
drugs such as chemotherapy medications, antiviral
drugs, hormone agents, and more can cause severe-
ly adverse health effects. These include both acute
and chronic conditions, ranging from skin rashes,
infertility, spontaneous abortions, and congenital
malformations to cancers and immune disorders.
While the risks associated with the improper
storage and handling of HDs is well-known, previous regulations have failed to provide a comprehensive set of guidelines that covers the spectrum of
drugs within the purview of specialist pharmacists.
In 2008, the United States Pharmacopeia (USP)
sought to address this need in an update to USP
<797>, but the amendments primarily focused on
parenteral hazardous drugs and lacked sufficient
guidance for nonparenteral products. Efforts to create a new set of guidelines began a few years later in
March 2014, finally coming to fruition in February
2016 as what is now known as USP General Chapter
<800>. 2 Under these new guidelines, pharmacies,
hospitals, patient treatment centers, and physician
practice facilities are required to meet new, more
rigorous environmental and safety criteria to reduce
potential risks to healthcare workers and their
patients, with a key aspect of the regulations related
to the storage of products in cleanrooms.
The Dec. 1, 2019 compliance date may seem far
away now, but it is critical that all affected facilities
begin to assess their current environments, particularly cleanrooms. For some, the new requirements
could mean major renovations to these areas or
other changes that may impact workflow, processes, and purchasing decisions. One area of concern
for pharmacists and pharmacy managers will be
refrigeration, as these more stringent regulations
on the storage of hazardous drugs mean a compressor-based, pass-through refrigerator will no longer
be acceptable to ensure compliance.
Rethinking refrigeration
Today, many facilities use legacy refrigerators with
compressor systems. These units have always pre-
sented a variety of complications for healthcare
facilities, especially cleanroom environments,
with contamination being a primary concern. The
mechanical forces associated with their operation
can often create friction, causing the systems to wear
down with use and dispel particulates into the air
over time. In addition, the compressors’ close prox-
imity to the condensation trays can often promote
mold and fungus growth, disrupting the once-sterile
atmosphere.
Under USP <800>, all hazardous drugs must be
stored and compounded in externally ventilated,
negatively pressured areas with at least 12 air changes per hour. Specifically, refrigerated antineoplastic
hazardous drugs must be kept in a dedicated refrigerator which, if positioned in a negative-pressure
buffer room, should have an exhaust adjacent to the
compressor to minimize contamination and remove
airborne particles generated by the device.
Meeting the above standards could mean a significant investment in planning and construction to
accommodate a conventional refrigerator to store
pharmaceuticals, as it will involve specific design
changes to house the troublesome compressor outside the controlled environment and ensure external ventilation. An alternative solution some organizations may consider is placing the conventional
refrigerator outside of the controlled environment
altogether.
While this could mitigate construction costs,
which would likely pose a serious financial burden
for many organizations, doing so could dramatically reduce workflow efficiency. Utilizing this type
of system, personnel would be required to remove
their protective clothes every time a product is
needed, retrieve it from the external refrigeration,
and then re-apply the protective gear to re-enter
the cleanroom — a time-consuming and frustrating
process that is sure to hinder operations and patient
care, and also enhance overall risks of contamination.
The placement restrictions associated with compressor-based units are just one of the many challenges they pose to cleanrooms. Another is heat.
As anyone who has encountered a refrigerator will
know, the mechanical components in a compressor can get hot. This causes elevated temperatures
Meeting USP <800> cleanroom storage regulations with ease.
Jerilin Kenney
Phononic