Controlled Environments - March/April 2018

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.