GNATUS Autoclave Bioclave 12L, Руководство пользователя

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Control of the pressurized and saturated steam sterilization
process
The Autoclave BIOCLAVE 12L is tested in the plant to check the capacity of sterilization, using for
this purpose the Biological Indicator (BI) model “ATTEST” of the manufacturer “3M” (Ministry of Health
Reg.: 10002070068) in order to attend to the requirements of ANVISA (National Agency of Sanitary
Surveillance) in Brazil and of international organizations such as AAMI (Association for the Advancement
of Medical Instrumentation) and CDC (Centers for Disease Control and Prevention).
Composition of the product: Plastic bottle containing a glass ampoule with nutrient broth and a strip
of paper impregnated with suspension of dry spores of Bacillus stearothermophilus - ATCC 7953.
NOTE: The registration at the Ministry of Health of this product is performed separately from the
Autoclave 12L, as the product “ATTEST” is not manufactured by Gnatus.
The BI test consists of an ampoule that contains and strip impregnated with 10 Geobacilus
sthearothermophillus spores. These organisms are particularly resistant to the steam sterilization
process.
All BIOCLAVE 12L autoclaves are tested at the production line following a procedure that ensures
the equipment’s efficiency to provide safe and sterilized articles.
Maintenance of the qualification
In order to maintain the quality and the sterilization efficiency during the equipment’s regular use,
the BI test must be carried out routinely. To perform this test in the same place where the autoclave is
installed, it must be used the ATTEST control system, which consists of BI test ampoules and an incubator,
which allows the incubation of the test ampoule and the verification of the final result, 48 hours later.
Testing procedure using biological indicators
1) Make a test package that allows the steam to penetrate into it, place a BI inside it, and place
the test package in the coldest part of the autoclave (in this case, the coldest part of the BIOCLAVE is
the upper part, near the door), with the load for a routine cycle.
2) Identify the test package that contains the BI, remember that this package shall be opened to
remove the BI.
3) Once the cycle is finished, wait until the package is cold, then open it and remove the BI; break
the BI ampoule inside the specified incubator and incubate it for 48 hours.
4) At the same time, place a BI ampoule (one that hasn’t passed through the sterilization process)
into the incubator, in order to verify the incubator operation and also to control the viability of the spores
used in the test; check the BIs (both the positive control and the test ampoule), follow the directions
provided by the manufacturer.
5) Record test data and its results in a record system
6) If the BI test’s results were positive, don’t use the equipment until it has been checked and
repaired by the authorized technical service.
Attest biological monitoring system for steam sterilization
process
For more information about biological and chemical control, access www.3M.com/br/hospitalar
CONTROL OF THE STERILIZATION PROCESS