“We are a small, independent compounding
pharmacy that recently purchased an isolator/glovebox to comply with USP 797. What
is a recommended method for cleaning an
An isolator/glovebox is a miniature version of a cleanroom and is often certified to ISO cleanroom classifications. Therefore, the clean- ing methods for cleanroom environments as described in IEST-RP-CC018.4, Cleanroom
Housekeeping: Operating and Monitoring Procedures and
International Standard ISO 14644-5, Cleanrooms and associated controlled environments – Part 5: Operations may be
used to clean an isolator/glovebox.
During development and prior to implementation of any
cleaning protocol, it is recommended that this cleaning protocol be reviewed and approved by both safety and quality
managers. All cleaning agents used should be product compatible, process compatible, compatible with isolator/glovebox construction materials, and environmentally compatible.
All cleaning should be carried out bboth efore and after
every manufacturing, preparation, or dispensing session, as
well as in between activities that may result in cross contamination.
The recommended cleaning sequence for both a clean-
room and an isolator/glovebox is:
• Clean from the cleanest area to the dirtiest area
• Vertical airflow—top to bottom
• Horizontal airflow—wall to return
Just as in cleaning a cleanroom, the ceiling or the top
of the isolator/glovebox is cleaned first, taking care not to
compromise the HEPA or ULPA filters, then the back wall
of the isolator/glovebox, the right and left sides, the inside
front panel, and the floor of the isolator/glovebox. The rec-
ommended validated cleaning methods are:
• When cleaning the sides of the isolator/glovebox, over-
lapping, straight, pull and lift strokes are performed
cleaning either left to right or right to left or top to bot-
tom (see Figure 1). Begin cleaning at the rear of the iso-
lator/glovebox and work towards the front. When clean-
ing the floor of the isolator/glovebox, one can wipe from
the rear of the box to the front in a modified figure- 8
pattern. (See Figure 2).
• Inspect the wiper surface after each pass. If there is no
visible contamination, you may use the same surface of
the wiper up to four consecutive passes.
• Use a quarter-folded wiper so that gloves are not contaminated and a clean surface of the wiper is used for
each pass. The 12” X 12” wiper is folded into four quarters to obtain eight clean surface areas.
• There are commercially available cleaning tools such as
wands that will hold a wiper and/or pad. Use this isolator cleaning tool for areas hard to reach. Change the
wiper or cover after each isolator surface.
• Use polyester swabs for crevices and other hard to clean
areas. Change swabs after each use.
An example of a generic standard operating procedure
for cleaning an isolator/glovebox is listed below.
1. Begin by wearing all the appropriate PPE (personal protective equipment). This should be determined by the
2. Be certain the system is in operation.
3. Put on approved disposable gloves. Wipe the outside of
the isolator/glovebox front and sides with approved cleaning materials and wiper. NOTE: Toss soiled wipers into
a waste chute or appropriate waste disposal device after
each step or when the clean surface of wiper is soiled.
4. Wipe down gloved hands and the containers of cleaning products to be used with wipers pre-saturated with
sterile 70% Isopropyl Alcohol (or approved cleaner) and
place products in the isolator/glovebox. Check that all
tools used to clean the isolator/glovebox are wiped clean
before cleaning interior. Remove the disposable gloves.
5. Place hands into the integrated gloves of the isolator/
glovebox. Mist and wipe down integrated gloves with
Recommended Practices in
Figure 1: When cleaning
the sides of the isolator,
use overlapping, straight,
pull and lift strokes.