on design, certification, and operations.
CE: What are some of
the most common problems that you see?
RM: No low level exhaust
in hazardous areas, such as
chemo and nuclear pharmacies,
and no low level returns in nonhazardous or low risk pharmacies. All
of the responses to the first question are
common problem areas. And certification
reports are not detailed enough.
CE: In order to prevent cross-contamination, is
the amount of space or the arrangement of the
space most important? Or is it a balancing act?
RM: Arrangement of doors, HEPA location, and return location will help dramatically, but hood and movement
in the rooms is a critical component as well. 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.
CE: Should (or can) a facility certify their
own airflow and room pressure?
RM: I do not recommend this due to the expense of equipment,
training of competent individuals to perform the tests, constant
changes in the standards, and the issue of the fox guarding the hen
house. There is also instrument calibration and continuous training
for technicians to keep abreast of new techniques and instruments.
CE: What are the guidelines for appropriate intervals for certification?
RM: Every six months for certification is the minimum, and
continuous monitoring will be required when and if the FDA
gets their bill in the Senate passed.
CE: Anything else you would like to add?
RM: Gravity is your friend, and all particles larger than five
microns are affected by it. A person is the dirtiest item that
enters your cleanroom. HEPA filters should always be in
the ceiling for first air, and test ports must be installed
to accurately scan or test HEPA filters. There shouldn’t
be cabinets in any room; sinks should be deep to limit
splash; faucets should be foot pedaled with a tankless hot
water system. Leave the area below the sink open for ease
of cleaning and ease of plumbing failure recognition. I
prefer doors to swing in and use pull handles to exit; this
makes them hands-free like operating rooms. The room
shouldn’t have ledges, and always use cleanroom lights.
Get a competent consultant to work with an engineer and
architect in designing your rooms—experience counts.
Interlock supply and exhaust systems are needed if doing
chemotherapy. And lastly, be sure HVAC systems are continuously running and are not turned off at night or on