The wake-up call to compounding pharmacies nationwide means a closer eye
Editor C ompounding pharmacies have made news during the past year, and it has not been a pleasant time in the spotlight. In a dramatic and unfortunate scenario, New England Compounding Center’s tainted steroids
were linked last fall to meningitis and other infections. The
ensuing surprise inspections of compounding pharmacies
in Massachusetts uncovered broader problems that ranged
from citations for minor violations to facility shut downs. In
all, only 10% passed inspection statewide. The director of the
Massachusetts Department of Public Health’s Bureau of
Health Care Safety and Quality said many of the problems pin-
pointed by investigators related to flaws in the design or opera-
tion of the companies’ cleanrooms.
To look further into the issue regarding design and
control within compounding pharmacies, Controlled
Environments spoke with Rick Meyer, President, Superior
Laboratory Services Inc., Pasadena, Texas. Rick has 35 years’
experience in the construction, design, installation, consulting, repair, certification, and maintenance of laboratories,
cleanrooms, and filtration systems. He has designed, built,
consulted, and certified over 100 USP-797 facilities since
2004. In addition, Rick has tested/certified over 2,000 cleanrooms, designed/built over 900 cleanrooms, and certified
over 75,000 hoods. He is a member of six IEST working
groups, including HEPA leak testing, nano facility design,
nano safety, and USP-797 facility design. Rick currently participates as a member of the ISO-14644 TAG team to review
and comment on those standards.
Controlled Environments: How does facility design affect controls?
Rick Meyer: Poor design will and does lead to potential contamination. Items to watch are:
a) Seals of penetrations
• Lights are sealed ISO- 7 cleanroom lights only
• Electrical switches and outlets
• Plumbing drains and supplies
• Fire alarms and sprinkler heads
• Door frames, latch holes, and hinges
• Ceiling tiles and grids
• Floors without integral coving
• Pressure, temperature, and humidity sensors
• Communication systems
All of the above have the potential to
allow spiders, ants, roaches, or other
insects to contaminate the clean-
room from wall cavities.
b) Supply and return air location
• Supply HEPA should be in the ceiling for first air in the room to
be clean with no run to contaminate—and for ease of
leak testing HEPA with
the preferred method of
scanning the HEPA.
• The return should be
located at floor level
and in all corners about
six inches off the floor.
Be sure that returns are not
near doors or in the ceiling.
• Door sweeps are never recommended and neither are gaskets on
the frame; they are just a source of potential contamination and very difficult to clean. Sliding
doors have issues as well, and cleaning them is extremely
difficult (i.e., tracks, roller wheels, gaskets between door
• Cabinets should be avoided by all means and laminates
should never be used. Laminates are not smooth, impervious, free of cracks, crevasses, and/or seams. They also have
wooden substrates that are not non-hydrophobic as are
doors. We find our tops and bottoms to be exposed wood
in many locations and see growth on them regularly.
CE: Can poor design be overcome?
RM: Not really, for the longer the facility is in operation the
more you will realize the design flaws.
When designing a cleanroom, the size of
the room and the number of occupants is
extremely important. Be aware that the
expansion for pharmacies is a foregone
conclusion, so be prepared for the inevitable.