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1 High Temperature Application Guide
Let Kanomax Help You
Meet USP 797 Regulations
USP 797 sets standards for compounding sterile
preparations to ensure patient and worker safety
USP chapter 797 is an enforceable regulation from
the United States Pharmacopeia that addresses
safety concerns regarding Compounded Sterile
Preparations (or CSP for short). USP 797 came about
due to several incidents of contamination that were
introduced during the compounding process. This
contamination caused several fatalities prompting
the need for an enforceable regulation to govern
the compounding of sterile preparations. While it is
not federally regulated, nearly all states do have laws
that refer to USP 797 either directly or indirectly, and
even in the few states where there is no regulation
a hospital or pharmacy may still want to follow USP
797 as a best practice to maximize patient safety and
minimize liability.
Application Note
can be present within the controlled environment.
Airborne particulates can pose a hazard because
some of them may be biological contaminates such
as bacteria or mold, and even inorganic particulates
may be pyrogenic in nature or pose risk of infection.
Limiting the amount of particulates present in the
compounding area lowers the risk of contamination.
A sterile, controlled environment is key to safe
compounding and compliance with USP 797
The purpose of this application note will not be to
explain USP 797 in detail, but to explain how you
can use our particle counters and other Kanomax
products to help your business comply with the
regulation. The regulation species that an ISO class
5 clean room environment is required for critical areas
where the compounding preparation is exposed to
ambient air. A class 7 buer zone is required around
critical areas and there also needs to be a class 8
anteroom for gowning and preparation. These ISO
classes are all guidelines to how many particulates
Copyright © 2014 by Kanomax USA, Inc.
The Model 3905 or 3910 portable particle
counter is a versatile tool not only for particle
counting, but also for air velocity, temperature,
humidity and pressure measurements
Kanomax oers several particle counters that can help
your pharmacy or hospital meet the requirements of
USP 797. Model 3887 is an economical handheld
unit suitable for spot-checking non-viable particles
or even certifying smaller cleanrooms in the ISO
class 5-8 range. The optional printer is highly
recommended for this application as tamper-proof
hard copies are an important part of documenting
compliance. We also oer higher owrate portable
units (models 3905 and 3910) that come with a builtin printer and can be used to certify a cleanroom
much faster than a smaller handheld unit can. These
portable units are best suited for larger areas where
multiple samplings are required at many dierent
points (per the ISO procedure). The portable units
are designed to make certication easy with preprogrammed standards modes that can guide you
by providing the correct number of points to sample
and automatically calculating the results.
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2 USP 797 Application Guide
The smaller handheld units can also be used to
check the eectiveness of HEPA lters in the eld.
By sampling the air on each side of the lter you can
identify if there’s a problem or make an informed
decision about when to replace the lter. Similarly
the AES-1000 wall-mount unit is a good choice for
the anteroom area as its easy-to-see visual indicator
and audible alarm can alert personnel of potential
contamination in the anteroom before it spreads
into other areas. The AES-1000 can easily be linked
into your existing ethernet network to provide
remote reports and warnings.
Kanomax also oers many options for checking
airow and air exchange rates within the cleanroom.
In order to eectively control particulates the
ventilation system in the cleanroom must have a
laminar ow that evenly pushes air and particulates
in one direction so they are removed from the
cleanroom or it needs to perform sucient number
of air exchanges per hour to ensure particles are
being eectively removed through the dilution
process. Our handheld anemometer line and airow
capture hood are perfect choices to help regulate air
ow and exchange rates within a UPS 797-compliant
cleanroom. The 2% accuracy of the Climomaster
TM
makes it a very good choice for performing airow
measurements to check a cleanroom or PEC (Primary
Engineering Control such as a laminar owhood
or biosafety cabinet). Using a less accurate tool
introduces uncertainties that can make regulating
the ventilation dicult.
Finally we oer several ways to test temperature,
humidity and pressure levels which is also a
TM
requirement of USP 797. The Climomaster
and
portable particle counters have the capability of
measuring these additional parameters if you’re
looking for a consolidated or all-in-one testing. We
also oer a 24/7 cleanroom monitoring system and
IAQ monitor that can be setup in your cleanroom
to monitor particulates, temperature and humidity
continuously. Finally we have a variety of ways to
check pressure such as the optional dierential
TM
pressure sensor on the Climomaster
or the
portable particle counters as well as a wide range of
pitot tubes.
About Kanomax USA, Inc.
Kanomax has delivered the best measurement solutions
in its products and services that adapt precision measurement technology for uids and particles. Kanomax
product lines include anemometers, particle counters,
dust monitors, and IAQ monitors. Kanomax is contributing to technological innovation and quality improvement
for the processes of quality management, environment
management, and technology development in the areas
of environment, health , and energy, which are essential
to sustain human well-being, as well as in other industrial
areas including automobile, aerospace, semiconductor,
electronics manufacture, heavy industry, steel, shipbuilding, pharmaceutical, biotechnology, food-processing,
medical, construction, and civil engineering.
The ClimomasterTM features a 2% accuracy and can
also measure temperature, humidity and pressure
depending on the options and probe selected
Copyright © 2014 by Kanomax USA, Inc.
Kanomax USA, Inc.
P.O. Box 372
219 US Hwy 206, Andover, NJ 07821 USA
TEL: 800-247-8887 (USA) * 973-786-6386
FAX: 973-786-7586
E-mail: info@kanomax-usa.com
URL: www.kanomax-usa.com
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