Operational Qualification OQ Version 1.

1
see relevant version operating instructions

Hettich-Centrifuge: Typ Nr.:

Serial-Nr.:

Year of manufacture:

Is a free safety area of 300 mm around the centrifuge according to

EN / IEC 61010-2-020: yes: no:
Andreas Hettich GmbH & Co. KG will not be liable for any damages due to user’s failure to follow all
use and safety instructions in the Operator’s manual

Rotor Batch Running Running Max. Max. read calculated

cycles time speed load

Running Running Max. Max.

Bucket Batch read calculated
cycles time speed load

Measuring instruments used

Speed: Test instrument – No

Running time: Test instrument – No

1)
Temperature Test instrument – No

Calibration certificates on file and comply with the requirements? yes: no:

Task Name Function Date Signature

Test Project Manager Hettich

Approval Project Manager Client

Page 1 of 4 S 04 06 1
 Operational Qualification OQ Version 1.1
see relevant version operating instructions

Running parameters defined by the user

Start-up Brake Temperature

1)
Radius Speed RCF Running
time
-1
°C mm min min

Temperature recorded by means of calibrated sensor in the medium 1)

Measured Values

Medium starting temperature °C Ambient temperature °C

- after the first run (30 min): Medium: °C display °C Diff. K*

- after the second run (30 min): Medium: °C display °C Diff. K*

* permissible T ± 2 K
Recorded speed values

Max. targ. value RPM Actu.value: RPM Diff. ± < 1% oder < 50 RPM RPM

50% targ. value RPM Actu.value RPM Diff. ± < 1% oder < 50 RPM RPM

Checking the running times by stop watch

Diff. ± < 1 %
Targ. value min sek Actu. value min sek Diff Min sek

1)
only refrigerated units

Task Name Function Date Signature

Test Project Manager Hettich

Aproval Project Manager Client

Page 2 of 4 S 04 06 1
 Operational Qualification OQ Version 1.1
see relevant version operating instructions

For all models but not Roto Silenta and TACSI

The “running parameters defined by the user” are to be given by the user before
device testing and to be entered manually into the test schedule.
Details that are necessary:
0.) Run-up (acceleration figure / 1-9)
1.) Run-down (braking figure / 0-9 or R0-R9 or B1-B9)
2.) Temperature (in the centrifugal chamber / settable from –20°C to +40°C)
3.) Radius (Outer edge specimen container to the spindle axis in mm)
4.) Speed (revolutions per minute)
5.) RCF (the relative centrifugal force / the G figure)
6.) Running time in minutes

The radius, the speed and the RCF are in direct relationship to one another and the
corresponding values are stored in the device software. Inputting the radius and the
RCF automatically generates the speed, for example, via the software. Inputting the
radius and speed automatically generates the RCF.

Please consult the appropriate operating instructions for Hettich Centrifuges for
“Run-up” and “Run-down” figures.

Task Name Function Date Signature

Test Project Manager Hettich

Aproval Project Manager Client

Page 3 of 4 S 04 06 1
 Operational Qualification OQ Version 1.1
see relevant version operating instructions

Testing the temperature by means of calibrated sensor in the medium

(glycerine):
The medium starting temperature and the ambient temperature (Target = +18 to
+24°C) are measured and documented manually in the inspection schedule.
After 2 test runs, one after another, each of 30 minutes duration, the device display
and the medium temperature are documented manually in the inspection schedule.

Checking speed:
The rotational speed is measured twice by means of stroboscope. The first
measurement is carried out in accordance with the preset speed setting (Point 4 of
the running parameters defined by the user). The second measurement is taken at
only 50% of the preset speed setting (Point 4 of the running parameters defined by
the user). Both figures are documented manually in the inspection schedule.
The acceptance criteria are attained when the recorded speeds do not exceed a
difference of ±<1% of the set speed or the speed difference is ±<50 RPM.

Checking running time:

The set running time (from the press of the “START” button to the beginning of
deceleration) is checked once by means of a stop watch. The time recorded is
documented manually in the inspection schedule.

The acceptance criterion is attained when the difference between the target value
(Point 6 of the running parameters defined by the user) and the actual value is ±<1%
of the target value.

Safety instructions:
According to EN / IEC 61010-2-020, no persons, dangerous substances or objects
may be within the safety area of 300 mm around the centrifuge when the centrifuge is
running.

Task Name Function Date Signature

Test Project Manager Hettich

Aproval Project Manager Client

Page 4 of 4 S 04 06 1