|
|
|
|
|
CHEMICAL INDICATORS -
INFORMATION AND PRODUCTS |
|
|
|
Chemical indicators are one of the three critical devices for
monitoring a
sterilization
process. They are designed to respond with a characteristic
chemical or physical change to one or more of the physical
conditions within the sterilizing chamber. Chemical indicators
are intended to detect potential sterilization failures
immediately that could result from incorrect packaging, incorrect
loading of the sterilizer, or malfunctions of the sterilizer. The
Association for the Advancement of Medical Instrumentation has
defined five classes of chemical indicators: Class 1 (process
indicator); Class 2 (Bowie-Dick
test indicator); Class 3 (single-parameter indicator); Class 4
(multi-parameter indicator); and Class 5 (integrating indicator).
FDA
defines a physical*/chemical sterilization process indicator (21
CFR 880.2800(b)) as: A device intended for use by a health care
provider to accompany products being sterilized through a
sterilization procedure and to monitor one or more parameters of
the sterilization process. The adequacy of the sterilization
conditions as measured by these parameters is indicated by a
visible change in the device.
Compared to
biological indicators:
In
one study, chemical indicators were more likely than biological
indicators to inaccurately indicate sterilization at marginal
sterilization times (e.g., 2 minutes). Chemical indicators should
be used in conjunction with biological indicators, but based on
current studies should not replace them because they indicate
sterilization at marginal sterilization time and because only a
biological indicator consisting of resistant spores can measure
the microbicidal killing power of the sterilization process.
Placement of chemical indicators:
Chemical indicators are affixed on the outside of each pack to
show that the package has been processed through a sterilization
cycle, but these indicators do not prove sterilization has been
achieved. Preferably, a chemical indicator also should be placed
on the inside of each pack to verify sterilant penetration.
Chemical indicators usually are either heat-or chemical-sensitive
inks that change color when one or more sterilization parameters
(e.g., steam-time, temperature, and/or saturated steam; ETO-time,
temperature, relative humidity and/or ETO concentration) are
present. If the internal and/or external indicator suggests
inadequate processing, the item should not be used. An
air-removal test (Bowie-Dick Test – a Class 2 indicator) must be
performed daily in an empty dynamic-air-removal sterilizer (e.g.,
prevacuum steam sterilizer) to ensure air removal.
IMPORTANT NOTE:
The “pass” response of a chemical indicator does not prove the
item accompanied by the indicator is necessarily sterile.
Indicators come in many different forms including on
autoclave tape,
labels,
pouches,
Bowie-Dick Tests and more
(see
Supplies
for our
complete list).
|
|
Defined…
Chemical indicators are one of the three critical devices for monitoring a
sterilization process. They are designed to respond with a characteristic
chemical or physical change to one or more of the physical conditions within
the sterilizing chamber. Chemical indicators are intended to detect
potential sterilization failures immediately that could result from
incorrect packaging, incorrect loading of the sterilizer, or malfunctions of
the sterilizer. The Association for the Advancement of Medical
Instrumentation has defined five classes of chemical indicators: Class 1
(process indicator); Class 2 (Bowie-Dick
test indicator); Class 3 (single-parameter indicator); Class 4
(multi-parameter indicator); and Class 5 (integrating
indicator).
|
|
Bowie-Dick Type Tests
(for Dynamic
Air-Removal Sterilizers)
Air Removal Test
Pack
–
Intended to evaluate the performance of the air removal (vacuum) system of
dynamic pre-vacuum type sterilizers. Lead Free Ink on Indicator Sheet
provides distinct, non-reversible pink to brown/black color change – easy to
interpret.
For Pre-assembled,
Disposable Test Packs: Upon completion of the
cycle, open the pack and remove the indicator sheet. File test with your
sterilizer records. Test packs are 510 notified and meets AAMI, EN-867-3
and ISO 11140 air removal test.
For Individual Test
Sheets: Test sheets allow you to
assemble your own PCD (Process Challenge Device). Place the test sheet
within a stack of surgical towels that are assembled according to AAMI
guidelines. These test sheets meet AAMI, EN 867-3 and ISO 11140 air removal
test
Questions? Please call 877/287-1199 |
|
|
Bowie-Dick Tests |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-BDTLF20 |
20 per box |
$88.00 per box (only $4.40/test) |
$79.00 per box (only $3.95/test) |
|
|
CI-BDTLF |
80 per case |
$315.00 per case (only $3.93/test) |
$295.00 per case (only $3.68/test) |
|
 |
CI-BD110 |
100 per pack |
$33.75 per pack (only $.337/test) |
$29.75 per pack (only $.297/test) |
|
|
Indicator Labels For
Dry Heat Sterilizers
Change
from green to black color in 10 minutes at 160˚C. Color change is
non-reversible. Labels distinguish a processed item from one not yet
exposed to the Dry Heat sterilization. Expires 5 years from date of
manufacture. 1,000 labels per box. |
 |
|
Dry Heat Indicators |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-DHI |
Dry Heating Indicator Labels,
1,000 labels per box |
$25.00 |
$19.95 |
|
|
Indicator Labels For
Ethylene Oxide (EO) Sterilizers
EO
Indicator Labels change from purple to green when exposed to Ethylene Oxide
sterilization. Labels are laminated and distinguish a processed item from
one not yet exposed to Ethylene Oxide sterilization. Color change is
printed on the label and is non-reversible. Labels expire 3 years from date
of manufacture.
|
|
|
EO Gas Indicators |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-EO2 |
EO Gas Indicator Labels for METO® gun labels, 1,500 labels per roll |
$37.50 |
$35.95 |
|
 |
CI-EO3 |
12.7mm (.5”) - Imprinted EO Gas Indicator labels, 5,000 per roll |
$128.40 |
$115.00 |
|
|
Class
5 Chemical Indicators (Integrators) |
|
ProChem EXT Class 5
Steam Integrators
The
ProChem EXT’s are Class 5 Integrators with extended timing beyond
what is required for biological spore kill. The 2” bar changes to solid
black after sufficient exposure to three critical parameters: Steam, Time
and Temperature. Clear non-reversible color change in 7 minutes at 135˚C
(275˚F) and at 20 minutes at 121˚C (250˚F). 250 per box. |
Pass
Fail
Unused
|
|
|
Class 5 Integrators |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-EXT |
Extended-Timing Integrators for Steam sterilization, 250 per box |
$30.00/box |
$25.00/box |
|
|
Vapor Line®
“Pass/Fail” Class 5 Steam Integrators
Once
it reaches the “PASS” area, this indicates the sterilizer cycle has reached
the area beyond spore death. Test experiments by independent laboratories
have proven the equivalence of these Integrators to biological indicators,
offering immediate PASS or FAIL results. 250 per bag.
|
Pass
Fail
Unused
|
|
|
Class 5 Integrators |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
PSI-250 |
Vapor Line® Integrators for Steam sterilization, 250/bag |
$40.00/bag |
$35.00/bag |
|
|
ProChem SSI Class 5
Steam Integrators
The
ProChem SSI’s are also Class 5 Integrators. The circle turns to solid black
upon completion of the sterilizer cycle. Complete color change in 3 to 3.5
minutes at 132-135˚C and in 10 minutes at 121˚C.
(NOTE:
Has two integrators per strip; can be divided into two, for total of 500
tests!).
Only 4¢
per test!
|
Pass
Fail
Unused
|
|
|
Class 5 Integrators |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-SSI |
Integrators for Steam sterilization, 250 per box, (perfed to make 500) |
$20.00/box |
$18.00/box |
|
|
ProChem EO Integrators
Ethylene Oxide Integrator – Complete color change after sufficient exposure
to four critical parameters: EO concentration, RH, Time and Temperature.
Acceptable for use in 100% EO or one of the HCFC blends. Shows FAIL at 15
minutes and PASS at 45 minutes. (600 mg/L, 40-60% RH, 54˚C). Easy to
interpret with distinct, non-reversible color change. 510k notification and
meets AAMI/ISO 11140-1 Class 5 Integrator.
Questions? Want samples? Call 1-877/287-1199
|
Pass
Fail
Unused
|
|
|
Integrators for EO Gas |
Stock No. |
Description / Packaging |
Price (1-2) |
Price (3+) |
|
 |
CI-EOINT |
Integrators for EO Gas sterilization, 250/box |
$30.00/box |
$25.00/box |
Ask us
about:
Daily Autoclave Testing Requirements and
Recommendations in Ontario, Canada
|
|
|
|
ATS Inc. | Autoclave Testing
Service, Inc. | Dental Daily Testing | Spore Strip Testing | Ontario
Spore Testing Requirements | Products for Daily Testing |
|
|
