Healthcare Design - October 2017 - 44

In Focus

Previously, pharmacies with compounding areas were required to be at
positive pressurizations. Now, these spaces will need to be negatively
pressurized, which necessitates dedicated exhaust ductwork to the exterior, impacting where pharmacies are located in a building to minimize the
routing of exhaust equipment.
Existing pharmacies face tougher challenges, though, such as adapting
existing wall systems to create new separations and accommodating new
workflows and air-handling systems. Modifications will vary widely depending on existing conditions and the types of drugs the pharmacy prepares, ranging from executing minimal door or wall reconfigurations to
relocating whole departments to maintain operations while new spaces
are constructed. These types of projects will need to be evaluated on a
case-by-case basis to determine the least impactful process. Collaboration
between designers and pharmacy and facilities staff will be essential to develop the appropriate solution.

2/5

UNPACKING
ROOM

WORK
SURFACE
AND
STORAGE

HAZARDOUS
BUFFER
ROOM

HOOD

WORK SURFACE
AND STORAGE
REFRIDERATOR

ANTE ROOM

DIRTY

CLEAN

HOOD
SINK AND
EYE WASH

NON-HAZARDOUS
BUFFER ROOM

As facilities look to adopt these new guidelines, they should focus on three
areas of concern: unpacking spaces, preparation/compounding spaces,
and storage spaces.
1. Unpacking spaces
The rule: Unpacking hazardous drugs from shipping containers can't occur in an area that's positively pressurized relative to surrounding areas.
What it means: Pharmacies are typically designed at a positive pressurization, and, currently, many pharmacies use their general pharmacy space to
unpack hazardous drugs. This means they need to find a new place to unpack. Additionally, the containers used to ship hazardous drugs can contain
harmful chemicals that present a risk to workers. In a positively pressurized
environment, those residues and gasses may drift into adjacent areas. Unpacking in a negatively pressured or neutral environment prevents this.
Design options:
* Identify an existing neutral area within the general pharmacy that can be
designated for unpacking hazardous drugs.
* Unpack hazardous drugs in a negatively pressured hazardous drug storage room.
* Unpack in a neutral or negative area outside of the pharmacy (general
shipping or receiving area).
2. Preparation/compounding spaces
The rule: Hazardous-drug compounding must take place in a containment primary engineering control (C-PEC), or hood, located in a dedicated
secondary engineering control (S-SEC) room, or buffer room, that's externally ventilated, physically separated from other areas, and maintained at a
negative pressure. In addition, sterile and nonsterile hazardous drugs need
to be prepared in separate rooms, unless primary engineering controls
(PEC) allow ISO Class 7 conditions, which relate to clean room design and
correspond to the amount of particulate matter in room air, to be maintained continuously in the room where required.
What it means: There are two considerations at play here: separating hazardous drug preparation from nonhazardous drug preparation and separating sterile hazardous drug preparation from nonsterile hazardous drug
preparation. Previously, compounding pharmacies could process sterile
hazardous drugs and sterile nonhazardous drugs in the same room. However, USP 800 will require the same pharmacy to have two buffer rooms, one
negative (hazardous) and one positive (nonhazardous). To access the buffer rooms, a positive-pressure ISO Class 7 anteroom is needed. (ISO Class
7 buffer rooms and anterooms aren't required for lower-risk hazardous

OCTOBER 2017

New compounding
pharmacies designed
under USP 800 will
require separate buffer
rooms for hazardous
and nonhazardous
drugs, as well as
special accommodations for storage and
unpacking.

HCDMAGAZINE.COM

drugs, which are outlined in the USP 797 and 800
standards, but the more conservative approach is
best here.) Although the processing of sterile and
nonsterile hazardous drugs can theoretically occur in the same buffer room, the reality is that it
would be impractical in most cases because it's
challenging to keep a room sterile while there are
nonsterile processes occurring. Considering this,
USP 800 recommends that the two be separated.
Design options:
* Design around a shared positively pressurized
anteroom to serve both a dedicated hazardous
and a nonhazardous buffer room.
* Convert a space adjacent to the existing compounding room into a dedicated hazardous
buffer room.
3. Storage spaces
The rule: Hazardous drugs that require manipulation, such as those mixed with various drug
components to create a specific prescribed drug
combination or a reduced dosage of a manufactured drug for administering to a child, must be
stored separately from nonhazardous drugs
in an externally ventilated, negative-pressure
room with a minimum of 12 air changes per hour
(ACH), which is how many times the air within a
defined volume of space is replaced through supply or exhausting of air.
What it means: USP 800 will have the biggest
impact on pharmacies that prepare several different types of drugs, such as nonhazardous
sterile drugs, hazardous nonsterile drugs, and
hazardous sterile drugs. Currently, many pharmacies use the same room for storing hazardous
drugs (both sterile and nonsterile) and nonhazardous drugs. USP 800 limits where hazardous

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Healthcare Design - October 2017

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