Calibration

Protocol
Prepared: RS | 05.10.2009 425 | S03 Page 1 of 5

Tested: RM | 17.08.2010

Version 3.0

Calibration Protocol | Version 3.0 1|5

Test equipment Serial no:

Customer:

Test Description Specification Initial Date

®
BioSealer Ser. No.
Art-No.
Manufacturer Sartorius Stedim Switzerland AG Biotech/Reed
AG
Firmware Vers.

Test Description Specification Initial Date

Calibration Holder with integrated Art-No.
Temp.-Sensor Type K, Ni Cr Ni, class 2 Ser. No.
Manufacturer Sartorius Stedim Switzerland AG Biotech/Reed
AG

Test Description Specification Initial Date

Measuring instrument Ser. No.
Art-No.
Manufacturer

Acceptance criteria
All test descriptions must be completed with initial and date. If one of the criteria cannot be completed successfully, describe the variation.

Conformity

Signature (QSR) Needs criteria Not accepted Date

Incident Comment

Calibration Protocol | Version 3.0 2|5

Test procedure
The calibration

Calibration of the BioSealer®

Incident Activity
1 Make sure the unit has been switched off.

2 Clean both ceramic elements with alcohol.

3 Insert the Calibration Holder.

To calibrate the bottom heating element 1.6/2.4mm insert holder as shown in picture 1.
To calibrate the bottom heating element 3.2mm insert the holder as shown in picture 2.
To calibrate the top heating element 1.6/2.4mm insert holder as shown in picture 3.
To calibrate the top heating element 3.2mm insert the holder as shown in picture 4.

P1 P2 P3 P4

4 Close the lever.

Calibration Protocol | Version 3.0 3|5

Incident Activity
5 Connect the Calibration Holder to the measuring instrument and prepare it for record.

6 Start recording. Press the red button and hold it wile you switch on the unit. Hold the red button for 5sec. The calibration
process will start automatically.

7 The unit heats up to 100°C (pre heat temperature) and hold this temperature for 30 sec. After the unit heats further up to 150°C
(sealing temperature) and hold this temperature for 30 sec. At the end the unit cools down to 65°C (reopen temperature) and a
signal will acoustically indicate the end of the calibration process.
The maximal temperature tolerance between the calibrated measuring equipment (measuring instrument and Calibration Holder)
and the indicated temperature on the display at 150°C is +/-5°C

8 Disconnect the measuring instrument, open the lever and remove the Calibration Holder.

9 The unit is now again ready for a normal sealing process. If you like to start another calibration process, please start again at
incident 1.
10 If a calibration process does not finish correctly the unit will go back to the normal sealing process. Switch the unit of and start
again at incident 1

Calibration Protocol | Version 3.0 4|5

Acceptance criteria

The Temperature must be within +/- 5°C of the set temperature. In the time frame of 30 seconds is a setting time of maximum 7 seconds
included which means the first 7 seconds out of the 30 seconds can be outside tolerance. This is valid for both preheat and sealing
temperature.
The time is always counted backwards from the temperature were the unit heats further up after the preheat temperature or starts cooling
down after the sealing temperature.

All measuring instruments must be calibrated and documents are available or made. If one of the criteria cannot be completed successfully,
describe the variation

Conformity

Signature (QSR) Needs criteria Not accepted Date

Incident Comment

Measurement overview

Accepted criteria
All calibration activities and data must be completed. If one of the criteria cannot be completed successfully, describe the deviation.

Conformity

Signature (QSR) Needs criteria Not accepted Date

Incident Comment

Calibration Protocol | Version 3.0 5|5