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Objectives: labels and load cards are tainers for pack control
1. List the 6 different types of examples of externally visi- monitoring. They can also
indicators. ble chemical indicators that be used as an additional
are on the outside on the monitoring tool in order to
2. Describe the differences be- packages. be able to release loads
tween indicators and integra- that do not contain im-
tors. b. Class 2: Indicators
are intended for use in spe- plants based on the ap-
3. Discuss what chemical indi- cific test procedures as de- propriate Process Chal-
cators are. fined in relevant sterilizer/ lenge Device. These indi-
sterilization standards. . cators can also be used in
Chemical indicators have been
Bowie-Dicks are one type of implant loads IF a Biologi-
around as long as life itself. For
specific testing most are cal Indicator is run with
example, hydrangeas bloom
familiar with. These are the class 5 integrator.
blue in acidic soil and pink in
used to show the efficacy of The load can NOT be re-
basic soil so they are an excel-
air removal and steam leased until the BI result is
lent indicator of soil conditions.
penetration. known except in emergen-
That being said, chemical and
cies.
biological indicators were not c. Class 3: A single vari-
used routinely until the late able indicator that is de- f. Class 6: These are
1940s and early 1950s to moni- signed to solely show the called emulating Indica-
tor sterilization processes. At exposure to one sterilization tors which are cycle verifi-
that time, it was stated no single process at a stated value cation indicators which
quality-assurance monitoring (SV) of the chosen variable. are designed to react to
method assures that any item is One example of a single all critical variables for
sterile; rather it assures the con- variable is a temperature specified sterilization cy-
ditions for sterilization to occur tube that houses a chemical cles. In other words they
have been met. This statement pellet which melts at a spe- are considered to be in-
is still true in today’s sterilization cific temperature. dicative of a complete cy-
practices. cle by showing the pres-
d. Class 4: These are ence or absence of spe-
considered as multiple vari- cific time and temperature
Chemical indicators are either able indicators. They are parameters during a cy-
physical or chemical devices designed to react with two cle. They are currently
used to monitor one or more of or more of the critical vari- only available in the US
the process parameters of the ables and are intended to for steam sterilization.
sterilization cycle. Currently indicate exposure to a ster-
they are divided into 6 classifi- ilization cycle at SVs of the
cations. They are as follows: chosen variable. Examples Chemical indicators are
of these class 4s would be convenient, are inexpen-
a. Class 1: Process
the paper strips with a color sive, and indicate that the
indicators are intended
change chemical indicator. item has been exposed to
for use with individual
These are usually used in- the sterilization process.
items, e.g., containers,
side each package. In one study, chemical
to indicate that the unit
e. Class 5: Integrating indicators were more
has been directly ex-
indicators are designed to likely than biological indi-
posed to the sterilization
react with all critical vari- cators to inaccurately indi-
process and to distin-
ables. These can be used cate sterilization at mar-
guish between proc-
as internal chemical indica- ginal sterilization times
essed and non-
tors in all packs and con- (e.g., 2 minutes).
processed items. Indi-
cator tapes, indicator
Volume 22 Issue 3 Page 4