Process challenge device (or PCD) is an item designed to simulate product to be sterilized and to
constitute a defined challenge to the sterilization process and used
to assess the effective performance of the process. A PCD is a
challenge test pack or test tray that contains a biologic indicator,
a Class 5 integrating indicator, or an enzyme-only indicator.
The size and composition of the biological
indicator test pack should be standardized to create a significant
challenge to air removal and sterilant penetration and to obtain
interpretable results. There is a standard 16-towel pack
recommended by AAMI for steam sterilization consisting of 16 clean,
preconditioned, reusable huck or absorbent surgical towels each of
which is approximately 16 inches by 26 inches. Each towel is folded
lengthwise into thirds and then folded widthwise in the middle. One
or more biological indicators
are placed between the eighth and ninth towels in the approximate
geometric center of the pack. When the towels are folded and placed
one on top of another, to form a stack (approximately 6 inch height)
it should weigh approximately 3 pounds and should have a density of
approximately 11.3 pounds per cubic foot. This test pack has not
gained universal use as a standard pack that simulates the actual
in-use conditions of steam sterilizers.
Commercially available disposable BI test
packs that have been shown to be equivalent to the AAMI 16 towel
test pack also may be used. The test pack should be placed flat in
an otherwise fully loaded sterilizer chamber, in the area least
favorable to sterilization (i.e., the area representing the greatest
challenge to the biological indicator). This area is normally in
the front, bottom section of the sterilizer, near the drain. A
control biological indicatorfrom the lot used for testing should be left unexposed to the
sterilant, and then incubated to verify the pre-sterilization
viability of the test spores and proper incubation. The most
conservative approach would be to use a control for each run;
however, less frequent use may be adequate (e.g., weekly).
ATS, Inc. also stocks BI test packs or Bowie-Dick test packs – see
Supplies.
DID YOU KNOW?
§
Autoclave Testing Service, Inc. is one of the first companies
nationwide to offer a
Mail-In sterilizer
monitoring service using biological indicators. Serving the
healthcare industry throughout the United States and Canada since
1986, we have thousands of satisfied customers.
§
We have on-line test results
allowing you to access your results at your convenience! Your
Sterilizer Test Report (STR) is posted
on-line upon completion of
culturing, offering minimum turn-around time.
§
We have 24-hour test results for Steam sterilizers!
§
We have a comprehensive Glossary of Terms related to the sterile
processing area (scroll below to view the Glossary). This is
invaluable information, assisting you with this important area of
your facility.
ATS, Inc. now
stocks sterilization pouches, sterilizer cleaners, chemical
indicator products, sterilizers (new and used), ultrasonic cleaners,
water distillers, and more! (see
Supplies).
In-Office and Mail-To-Lab Testing!
Verify the sterilization process of all steam
sterilizers which include Statim, Midmark,
Tuttnauer, Lisa, Mocom and Pelton & Crane
sterilizers.
Bowie-Dick Test
Packs should be used daily to evaluate the
performance of air-removal (vacuum) system of
dynamic pre-vacuum type sterilizers. Available
as test cards or preassembled test packs.
Internal CI’s should be used within
each pouch or package, tray, or container. Class 5
Integrators should be used in conjunction with
physical monitoring and biological indicator
testing for verifying the efficacy of a
sterilization system. (See AAMI ST79:2006)
Recordkeeping is a must for all
sterile processing departments. This ensures
accountability and allows operators to trace
errors to their source. Tips on sterilizer
maintenance and technical advice are included with
each book.
