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Control of the pressurized and saturated steam sterilization process
All 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 AUTOCLAVE
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.
Preventive Maintenance
The equipment must suffer routinely measurements, following the current legislation of the country.
But, never with a period superior to 3 years.
For protecting your equipment, look for a Gnatus’ technical assistance for periodic reviews as
preventive maintenances.
Attention
In case of the equipment presents any abnormality; check if the problem is related to some of
the listed items under the item unpredictable (situation, cause and solution).
If it’s not possible to solve the problem, shutdown the equipment and demand the presence of
a technician from the nearest resale, or ask through the Attendance Service Gnatus: + 55
(16) 3512-1212.
Corrective Maintenance
The supplying of the circuits’ diagram, Part lists or any other information that permits the technical
assistance by the user, can be requested, since previously agreed.
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
