Controlled Environments (CE): What led to the
need for this cleanroom facility?
Jeff Serle (JS): Regulations in the hospital and
healthcare pharmacy have evolved significantly,
especially over the last 12+ years. These regulatory
changes have impacted the demand for cleanrooms
needed to prepare sterile IV preparations. When
hospitals renovate their facilities to augment, add
or improve cleanroom space, compounding operations must continue without interruption. Germfree
developed the Mobile Pharmacy Trailer (MPT), the
first USP 797/USP 800-compliant mobile cleanroom
to allow for seamless drug compounding operations
during hospital renovations.
CE: Who was involved in designing it?
JS: The MPT Cleanroom facilities were designed by
our in-house engineering and design teams, with
input from the user community (hospital pharmacists) and the cleanroom testing community, including the Controlled Environment Testing Association
(CETA) certifiers. The design was based on the
requirements of USP <797> and USP <800>, with
an eye on State Board of Pharmacies, who can adopt
USP guidelines into law or develop their own guidelines, which may or may not be directly in alignment
with the USP guidelines.
CE: What challenges were faced along the way?
JS: We faced a couple of challenges in the develop-
ment of the MPT. Our engineering team’s biggest
challenge was designing the environmental control
system that can maintain the demanding indoor air
requirements in a hospital pharmacy across the var-
ied climatic conditions experienced in the U.S. From
a process side, a key challenge for us was to develop
a standard product, the MPT, that would satisfy the
regulatory requirements of each state.
The challenge to develop the MPT cleanroom was a
natural fit for our design and engineering teams. We
utilized our experience in manufacturing high containment mobile laboratories and our background
in Primary Engineering Controls (PECs) to create
this new type of flexible cleanroom to fulfill a critical
CE: Can you comment on the size and cost?
JS: The Hospital Pharmacy Cleanroom is built
around a Germfree-specified version of a semi-trail-er platform suited for the extensive modifications
required to create the critical interior cleanroom
environments (zones). The overall trailer is 8.5’ wide
x 13. 5’ tall x 53’ long (plus an additional 2’ for the
redundant Environmental Control Units ECUs).
Cost for these units varies based on duration of use
or special requirements. The price includes all the
equipment required to operate a hospital pharmacy,
including the primary containment devices, also
manufactured by Germfree.
CE: Who will be utilizing this space?
JS: The space will typically be used by a hospital
pharmacy for their compounding sterile operations.
The cleanroom can accommodate a hospital pharmacist and three to four technicians during a normal
shift and operates 24 hours a day, seven days a week.
The units can also solve space constraints or surge
capacity demands on a healthcare facility. The MPT
is also an option for cancer treatment centers, as well
as use for clinical drug trials.
CE: Will this be a temporary or permanent fixture
on the campus?
JS: The Hospital Pharmacy Cleanroom Trailer is
designed as a temporary cleanroom space, which can
be relocated for use at multiple facilities during con-struction/remodeling or as an emergency relief platform. We maintain a fleet of MPTs that are available
for short-term lease. MPTs can also be purchased for
The Mobile Compounding
All photos: Ryan Henry,
Controlled Environments spoke with Jeff Serle, Senior Vice President/Chief Design Engineer of the Mobile Pharmacy Trailer, about the use of the mobile cleanroom facility.