10 Initial commissioning
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10.6 Calibration, qualification, validation
The operator’s quality assurance system may require that the temperature and
pressure measuring points and the value displays of the sterilizer be calibrated.
This can be required before commissioning or at regular intervals. In addition, it
may be required that the sterilizing process be qualified or validated at regular
intervals.
11)
Sterilization processes can be
validated
only by the operator. By qualification and
the possibility of batch documentation, THERMO Labortechnik AG assists you in
performing this validation.
Within the framework of pre-acceptance testing, each sterilizer is
qualified
in a
standard program (121 °C, 20 minutes). This means that an independent,
calibrated measuring system is used to determine whether or not the sterilization
process actually uses the predetermined parameters. Qualification is documented
by affixing a “Qualified” test sticker to the sterilizer.
We recommend that qualification be repeated annually by one of our after-sales
services. The next test date is written on the test sticker. Ask for a qualification or
an annual safety check including qualification.
If desired, the temperature measuring points, displays and printers can be
calibrated
at the factory prior to delivery. You will be given a test and adjustment
report for every position, which will show the error in measurement at the
temperature measuring point, of the indicating instrument, or of the printer relative
to a reference temperature. Calibration may also be performed by our after-sales
service at the operation site at a later point in time.
Monitoring sterilization parameters (batch documentation)
Within the framework of quality assurance during production or in safety
laboratories, sterilization data may have to be monitored.
Several fixed and flexible sensors are available for measuring media temperature,
local chamber temperature(s) and chamber pressure. Measured values are logged
using the integrated printer or a PC.
Integrated printer
The integrated printer logs the entire sterilization process: Process data (time,
reference temperature and chamber pressure) are printed in one-minute intervals.
In addition, it documents the date and time of sterilization, the batch number and
the sterilizing program including the selected sterilizing temperature and sterilizing
time.
Monitoring sterilization parameters on the PC
The sterilizer is equipped with a RS 232 port. This allows you to monitor and
document program execution (temperature, pressure, sterilizing time) from your
11)
Definition, translated from DIN 58 950-1: 1995-08
(Steam sterilizers for pharmaceutical sterilizing articles)
Adjusting
Adjustment means setting or balancing a measuring instrument so that the differences between the
measured values for the parameters relevant to the process and the value considered to be correct do
not exceed the given limits of error.
Calibration
Determining and documenting the differences, for the measuring instrument, between the measured
values for the parameters relevant to the process and the value considered to be correct.
Qualification
Formal and systematic proof of the functionality and suitability of the steam sterilizer for its intended
purpose. Qualifying includes calibrating and, if necessary, adjusting the parameters of the measuring
and controlling instruments relevant to the process.
Validation
Proof in accordance with Good Manufacturing Practice that procedures, processes, equipment,
materials, working steps, or systems really yield the expected results. Validation includes qualification.
