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Cleaning Practices for Cleanroom Contamination

Fran McAteer, MBA

Investing in a new cleanroom to achieve USP Chapter compliance is generally a substantial financial
and time commitment that often presents a number of workflow and logistical challenges along the
way. Once such an intensive project is completed, the effort required to maintain compliance may seem
pedestrian. However, meeting the requirements put forth in the chapter goes beyond just creating a
proper cleanroom; it also means implementing a robust cleaning and disinfection program after the
project is completed to ensure continued compliance.

To design pharmacy cleanrooms to meet specifications for HEPA filtration, air changes per hour,
pressure differential, and consistent levels of temperature and humidity, the construction materials
should be impermeable, have minimal shedding properties, and be easy to clean. In fact, frequent
cleaning of the cleanroom is key to maintaining contamination control of a sterile products environment
over the long term. Proper cleaning of controlled environments involves manual cleaning methods to
reduce dirt and other foreign particulate matter, followed by chemical disinfection treatments to reduce
contamination risk. Ultimately, cleaning frequency should be directly proportional to IV medication
preparation activity; maintaining active environmental monitoring will provide feedback on the
diligence of cleaning activities and allow for the optimization of cleaning frequency.

Equipment and Scheduling

Cleaning the cleanroom requires specialized equipment, including lint-free, disposable mop heads, non-
shedding wipes, buckets made of plastic or stainless steel, and HEPA-filtered vacuums. Using the wrong
equipment can actually contribute to higher contamination in the IV area. For example, if environmental
services personnel are cleaning the cleanroom with the same cloth mop head used for general cleaning
of the pharmacy, bathrooms, or other, non-sterile areas of the hospital, microorganisms can easily be
introduced into the cleanroom.

It is important to establish cleaning and disinfection policies and procedures that specify which cleaners
and sanitizers to use, as well as areas to be cleaned and frequency of cleaning. Cleaning personnel that
enter the sterile products area should be given initial and supplemental training on proper aseptic
gowning and garbing technique. As for scheduling, cleaning is best done during off-peak shifts, such as
nights and weekends, and should be done frequently. In order to track long-term compliance, create a
form that documents the cleaning process; the form should include the date and time, the area cleaned
and disinfected, and the initials of the cleaning personnel.

Choosing the Right Cleaning Personnel

Implementation of a robust cleaning program begins and ends with practitioners. Therefore, the first
decision should focus on determining who will actually perform the cleaning. Will it be members of your
existing pharmacy staff? Will you look to engage staff from the hospitals housekeeping or
environmental services departments? Does it make more sense to employ an outside vendor with
cleanroom cleaning expertise? This decision will have a major impact on the effectiveness of the
cleaning program as each of these choices has various advantages and disadvantages.

If you decide to employ existing pharmacy technicians to clean the cleanroom, it is important to
account for the additional labor capacity that will be required. One advantage of using existing
pharmacy personnel is that they already have a strong intrinsic knowledge of IV preparation,
equipment, documentation, and pharmacy culture. While employing pharmacy technicians in this way
can be a cost-effective alternative, keep in mind that cleaning may be construed by pharmacy staff as a
routine, mundane process that is detrimental to a successful career paththereby potentially
impacting their commitment to do the job well.
A second option is to employ hospital housekeeping or
environmental services personnel. This also can be cost
effective, but exercise caution as these staff members may not
have appropriate training in proper aseptic techniques and
personnel garbing processes needed to maintain USP Chapter
compliance. If you choose to take this route, reinforce existing
training with educational sessions on aseptic procedures and
proper cleanroom compliance practices; it is important to
emphasize the risk of contamination to IV medications that
can result from improper cleaning and the impact on patient

The third scenario is to hire a third-party vendor. When

considering this approach, it is vital to evaluate the past
experience of the company in cleaning and sanitizing
cleanrooms. As there are a number of companies that now
offer these services, this process will require proper due
diligence; be sure to establish that the company has properly
trained, certified, and experienced personnel, as well as the equipment, products, and solutions
necessary to comply with regulations.

General Cleaning Procedures

Regardless of who performs the cleaning and sanitizing, it is important to have a basic understanding of
how it should be doneeven if you are relying on an experienced third-party provider. When cleaning
the cleanroom, empty trash containers first and then vacuum ceilings, floors, and walls with a HEPA-
filtered vacuum. Caution should be exercised when cleaning the delicate ceiling HEPA filters and should
only be done using a vacuum with HEPA filtration. Cleaning HEPA filter grates with harsh solutions may
damage the filters, allowing for microorganism penetration.

Cleaning and disinfecting of equipment such as laminar airflow workbenches (LAFWs) and other
horizontal surfaces should be conducted with non-shedding, cleanroom-approved wipes. The physical
process should flow from top to bottom and back to front in a unidirectional motion using single
overlapping strokes. Floor mopping in the cleanroom should always be executed starting with the area
furthest from the point of entry/exit. The operators should literally clean themselves out of the room.
For mopping floors, a pull-lift technique should be employed (see Figure 1).

Click here for a larger version of the Figure.

It is critical to comply with the manufacturer-specified contact time, as this allows for proper
microbicidal activity to take place. There are automated mopping systems available, such as the
MopKing product from AmKing Technologies, that ensure measured amounts of sanitizer are applied
with each mop stroke and even provide documentation of time, area, number of mop strokes, amount
of sanitizer used, etc. Whether the disinfectant is applied manually or automatically, allow the solution
to remain on the surface for the time recommended by the specific product. Suggested sanitizers
include LpH se, Vesphene II se, Bleach, and Spor-Klenz; each of which has different active ingredients
(see Figure 2).

Click here for a larger version of the


Given the prevalence of antibiotic-

resistant microorganisms, such as
MRSA and VRE, and the overall
concern for nosocomial infections,
cleaning programs are most
effective when sanitizers and
cleaning products are rotated on a
periodic basis, which will help
combat microorganism resistance in
your cleanroom.

Monitoring Cleaning
It is important to frequently garner feedback on the effectiveness of your cleaning and sanitization
program. This is best accomplished via -compliant environmental monitoring measuring viable and non-
viable contaminant levels in the cleanroom. Viable particle monitoring evaluates microbial
contamination on surfaces or in the air, while non-viable testing evaluates particle counts at specific
size. Cleanrooms are classified according to the number and size of particles permitted per volume of
air, and 0.5 micron particles are the most commonly measured size.

Particle counts are found to be directly proportional to bacterial contamination levels. Thus,
environmental monitoring goes hand-in-hand with an effective sanitization program by providing a
continuous feedback loop on the performance of the program. An effective environmental monitoring
program should include sample sites, location maps, testing frequency, action/alert levels, and detailed
test procedures, and must be governed by standard operating procedures (SOPs) that document the
purpose, responsibility, and procedures necessary to the program. Monitoring results can be graphically
trended over time and by location to demonstrate overall effectiveness and control of the
cleaning/sanitization program.

Ultimately, proper cleaning and disinfection of your sterile products environment is key to compliance.
It is a specialized service that greatly impacts contamination levels, and therefore the safety of both
employees and patients. Simply using a sterile products cleanroom does little to protect your
employees, patients, and the medications themselves if compliant cleaning practices are not strictly
adhered to. Implementing, and most importantly, maintaining a proper cleanroom cleaning program is
vital to your overall pharmacy operation.

Fran McAteer, MS, MBA, is vice president of quality at Microbiology Research Associates, Inc, an FDA-
registered contract microbiology testing laboratory specializing in USP testing for pharmaceuticals,
biologics, and medical devices. Fran has expertise and experience in the implementation of USP
programs for hospital pharmacies, IV preparation, cleanroom engineering, and acts as a consultant for
many hospitals.