10 FACILITY MONITORING
Diagram courtesy of
Grifols Misterium and
Healthcare providers comprise a variety of entities with different scopes of service, all focused on providing care to patients. Hospital and other complex healthcare set-
tings require well-designed mechanical, electrical,
and communications systems. And, because hospi-
tals accommodate patients, healthcare profession-
als, visitors, and other types of stakeholders, they
must comply with varying regulations and codes.
One of the most highly regulated environments
in the hospital is the pharmacy — most specifically,
the sterile compounding area where production of
compounded sterile preparations (CSPs) is performed.
With the ever-changing sterile compounding compliance legislation for pharmacies and hospitals, the
pressure is now on top of pharmacy professionals to
address full regulatory compliance, which requires
profound technical and regulatory expertise.
Standards for appropriate procedures and
requirements for hospitals that produce compounded sterile preparations are set by the United States
Pharmacopeia (USP), a compendium of drug information published annually by the United States
Pharmacopeia Convention, a nonprofit organization. USP develops standards for preparing compounded sterile drugs to help ensure patient benefit
and reduce risks such as contamination, infection,
or incorrect dosing.
Guidelines govern both the sterile compounding
process and the compounding pharmacy environment, including cleanrooms. USP Chapter <797>,
which became effective on Jan. 1, 2004, was the first
enforceable standard for compounded sterile preparations (CSPs).
USP General Chapter <797> Pharmaceutical
Compounding — Sterile Preparations is a comprehensive regulation that applies to healthcare institutions,
pharmacies, and other facilities in which compounded sterile preparations are prepared, stored, and
dispensed. Its purpose is the prevention of infections
in patients using pharmaceutical products, as well as
the protection of pharmacy staff members who may
be exposed to pharmaceutical products. USP <797>
includes requirements for personnel, training, facilities, environmental monitoring, storage, and testing
of completed preparations. Failure to comply with
USP <797> introduces significant risk of harm to
patients due to chemical or microbial contamination
and/or physical contaminants.
Sterile compounding is one of the highest risk
areas of the pharmacy practice. Dust and other
low-level environmental pollutants, such as airborne microbes, aerosol particles, and chemical
vapors must be tightly controlled.
Cleanrooms have meticulous levels of contamination (ISO Class) specified by the number of
particles per cubic meter at a specified particle size.
Air entering a cleanroom from the outside must be
filtered to exclude dust. The air inside a cleanroom
must be constantly recirculated through high-ef-ficiency particulate air (HEPA) filters to control
contaminants that are generated inside the room.
Particle levels are tested using a particle counter
and microorganisms are detected and counted
using environmental monitoring methods.
USP <797> facility/engineering cleanroom
guidelines delineate the need for modern clean-
room environments that include the installation
Juan Miguel Cana
Contamination Control in
The importance of compliant sterile compounding areas.