G-202

Calibration Verification of Digital Temperature Devices

Section G — Equipment Revision 5 5 pages

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1.0 Purpose
The purpose of this procedure is to describe the process for the single point calibration
verification of digital temperature indicating devices.
2.0 Scope
This procedure is intended for the calibration verification of digital temperature reading devices

that are a self-contained unit (i.e. kangaroo thermometers, thermocouples, probe thermometers,

and other free standing NIST traceable temperature reading devices). This SOP also applies to
equipment with a fixed temperature indicator (i.e. water baths, incubators, ovens, gummy

manufacturing equipment etc.).

This procedure is not applicable to digital temperature/humidity sensors used in DicksonOne

Data Loggers.

3.0 Responsibility

3.1 It is the responsibility of all personnel to follow this procedure.

3.2 It is the responsibility of QC Laboratory Management to ensure the procedure is current

and is being followed.

3.3. It is the responsibility of the Metrologist to ensure the digital temperature indicators
being used are within their calibration date as per SOP G-201 Calibration Program.

3.4. It is the responsibility of the Metrologist to keep current calibration certificates for all
devices in this procedure as per SOP G-201 Calibration Program.

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4.0 Definitions

4.1 [SO -— International Organization for Standardization

4.2 IEC — International Electrotechnical Commission

4.3. NIST — National Institute of Standards and Technology

4.4 ANSI — American National Standards Institute

4.5 | NCSL—National Conference of Standards Laboratories

4.6 Fixed Temperature Device — A temperature probe or sensor that is a built into
production or analytical equipment and gives a reading on the equipment’s interface

4.7 Digital Temperature Device — A temperature measuring device that is not integrated
into any other equipment and gives readings from the device’s display

4.8 QC-— Quality Control

5.0 References

5.1 G-201, SOP, Calibration Program

5.2 G-201-F2, Form, Calibration Certificate

5.3. B-911, SOP, Continuous Gummy Manufacturing Process

5.4 B-911-F1, Form, Gummy Inline Equipment Verification Log

6.0 Procedures

6.1 It is recommended that digital temperature devices (devices that are not fixed) are
replaced at least every five years. Digital Temperature Devices that can be calibrated

must calibrated by an ISO Certified external calibration lab at least once every five

years and must have an accompanying certificate.

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6.2 For equipment with fixed digital temperature devices and specific calibration

instructions, the device may be adjusted by personnel familiar with and qualified to

perform the adjustment.

6.2.1 The common specification for verification is +/- 2°C of reference temperature

unless otherwise specified by the needs of the application or recommended by
the equipment manufacturer The common verification cycle for temperature

indicators is 1 year.

6.2.1.1 For instruments such as ovens and incubators that have a digital

readout of the temperature, the fixed temperature of the device can be

manually adjusted to the fixed point temperature using a NIST
traceable reference. If the digital display is out of specified limits an

offset can be recorded on the calibration verification documentation
and the indicator labeled with the offset adjustment.

6.2.1.2 All instrument information, calibration verification and environmental
data should be documented on form G-201-F2 Calibration Certificate.

6.3. For gummy line production, temperature indicators are integrated into the
manufacturing equipment and display on the manufacturing equipment’s user interface.

Verify that the temperature probes are operational as per SOP B-911 and document on

Form B-911-Fl. If temperature readings are unable to be verified, refer to the
supervisor and the troubleshooting section of the equipment’s instruction manual.

6.4 Quarterly Device Verification

6.4.1 For QC Laboratory temperature devices only, on a quarterly basis, each

temperature device should be challenged using a NIST traceable thermometer.
The purpose of this challenge is to ensure the temperature device is functioning

as needed.

6.4.1.1 Only devices used for temperature verification need to be challenged.

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6.4.1.2 Allowed ranges for challenge is + 2°C.

6.4.1.3 Results should be captured in a laboratory notebook.

6.4.1.4 If temperature device does not meet the acceptable criteria then it should

be removed from use.

6.5 Verification Process For devices :

6.5.1. For use as a reference standard, select a NIST traceable temperature gauge that
has been externally calibrated and verified in compliance with ISO/IEC and/or

ANSI/NCSL requirements. Internally calibrated temperature gauges do not

qualify as reference standards.

6.5.2 Select a temperature as the reference point that pertains to the instrument being

verified. For example: if the temperature indicator is used at ambient
temperatures, verify at room temperature. If the temperature indicator is used to

monitor a refrigerator verify at a temperature within the acceptable range of

refrigeration.

6.5.3. All instrument information, calibration verification and environmental data

should be documented on form G-201-F2 Calibration Certificate.

6.5.4 Ifa temperature device is removed from service for any reason including failed

verification the device in the Calibration Schedule must be lined out with the
notation “removed from service.” The device is no longer permitted in GMP

work areas.

6.5.5 For devices that pass verification a calibration sticker will be attached and the

unit returned to service. Because this device has been internally calibrated, it
cannot be used to verify calibration of other temperature sensing devices.

6.5.6 Some devices that have temperature read-outs are only for reference and must
be noted as so. These devices are not to be used to record temperature and a

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Standard Operating Procedure SOP No Rev
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Calibration Verification of Digital Temperature Page 5 of 5
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secondary, traceable temperature reading device must be used for GMP

activities.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/25/10 | Original - & | - | - |
| 1 | 04/01/13 | . Changed the SOP format & number Biennial review: Changed Title. Rewrote instructions for | 13-249 | B. Johns |
| 2 | 06/24/15 | calibration verification. Added G-201, Calibration Program reference. Added use of traceable reference standards. Scheduled review: Added information about temperature monitors . : Sac ley that are for reference purposes as J. Maignan | 15-0560 | B. Johns |
| 4 | 10/20/23 | Updated logo and format. Added information for inline devices. CC- | 23-0520 | B. Echevarria |
| 5 | 12/12/23 | Added quarterly thermometer challenges for QC Lab only. CC- | 23-0599 | J. Sassman |