Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 1 of 6

Door Open Recovery Full Chamber Verification

Objective

To verify that the DHL Cold Room recovers to normal operational temperature
i.e. specification 2°c to 8°c within 15 minutes of closing the chamber door
after been open for 10 minutes.

Procedure

1. Ensure that the DHL Cold Room has been switched on for a minimum of 6
hours prior to testing.
2. Follow the SOP (s) pertaining to assembly, set-up, operation and
calibration of the test equipment used.
3. Programme the data logging system with the temperature log rate of 3
minutes.
4. Position the calibrated data loggers / thermocouples in the DHL Cold
Room and load as indicated by Table 1.
5. Mark up the positions of where the data loggers / thermocouples are placed
on diagram 1. Include the location of fixed system objects (doors,
switches, lights etc) as locators so that the proper orientation of data logger
placement is recorded.
6. Verify that the chamber contains a full load consistent with normal
operation.
7. Close the chamber door and allow the chamber temperature to stabilise.
8. Once the unit has stabilised and is in a steady state condition, record the
time & date on Table 2 and open the door fully for a period of 10 minutes.
9. Close the door, record the time & date of door closure on table 2 and allow
system to recover and stabilise.
10. Continue to log the chamber and load temperatures for at least 1 hour after
the door closure.
11. Calculate the recovery time i.e. the time taken for the system to return and
remain within specification as indicated by the data loggers /
thermocouples.
12. Complete table 3 & 4.
 Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 2 of 6

Acceptance Criteria

1. DHL Cold Room will return to normal operation and the chamber load
temperature will recover within specification i.e. 2°c to 8°c with in15 minutes
of closing the chamber door after been open for 10 minutes as indicated by the
data loggers / thermocouples.
2. The door open event will not exceed 10 minutes.
3. During the study, no more than 2 data loggers / thermocouple malfunction is
acceptable. Exception: It is not considered acceptable for the data logger /
thermocouple adjacent to the control probe to malfunction.
4. The data logger / thermocouple records produced for the entire study, will be
stored electronically in a file called……………...
5. Test equipment calibration maximum deviation error +/-0.5 °c.
 Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 3 of 6

Table 1

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 Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 4 of 6

Diagram 1.

INSERT DIAGRAM OF CHAMBER AND LOAD PLUS DATA LOGGER

POSITIONS.

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Table 2

Table 3
 Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 5 of 6

Comments:

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 Performance Qualification

Document Number DHL 2

Version 0.1 Effective Date : 25/04/2014 Page 6 of 6

Table 4

Comments:

Reviewed By: Date: