SOP For Temperature Control Test Procedure

This SOP describes the temperature control test procedure used to demonstrate the capability of the HVAC system to control temperature in specified areas at Humanwell Pharmaceutical Ethiopia PLC. The procedure involves using calibrated temperature and humidity recorders to measure temperature at worst case locations over 3 days, both at rest and under dynamic conditions. The acceptance criteria requires room temperatures to comply with requirements in the validation master plan.

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SOP For Temperature Control Test Procedure

Uploaded by

Solomon Gamanuel

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Available Formats

Download as DOCX, PDF, TXT or read online on Scribd

SOP Overview
Implementation and Compliance
Record Keeping and Abbreviations

SOP for Temperature Control Test Procedure

Prepared by： X X
Department Name Date

Approve by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
The purpose is to demonstrate the capability of the HVAC system to control temperature.
2. Scope

This procedure is applicable to – HEPA filter Utilities in Humanwell Pharmaceutical

Ethiopia PLC
3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

The Utility division & the quality assurance manager are responsible for SOP compliance.

5. Material and Equipment

 Calibrated Dickson temperature and humidity recorder or equivalent
 Calibrated thermo-hygro recorder or equivalent
 Calibrated data logger
6. Procedure
6.1. Complete the air balancing of the area.
6.2. Measure the temperature at specified worst locations under “at rest” and
“dynamic” conditions.
6.3. Operate the system 6 hours prior to the test
6.4. Dickson chart recorder
6.4.1. Place the Dickson recorder in particular room after fixing new chart on it, for
3 days’ continuous monitoring.
6.4.2. After completion of 3 days, remove the chart from recorder.
6.4.3. Transfer the recorded data in a working format.
6.4.4. Keep the chart in a file for reference.
6.5. Thermo-hygro meter
6.5.1. Place the thermo-hygro meter in the specific location after date, time intervals,
setting printing options for 3 days.
6.5.2. After completion of 3 days, take printout from hygro meter.
6.5.3. Note down the reading in a working format.
6.5.4. Keep printout in a file for reference.
6.6. Data logger
6.6.1. Place the data logger in a particular location after loading the start time and
end time through computer software.
6.6.2. After completion of 3 days of data, remove from the area and download the
data by computer software and print.
6.6.3. Note down the data in a working format.
6.6.4. Keep the printout in a file for reference.
6.7. Acceptance Criteria
The room temperature should be in compliance with the room requirements, per
validation master plan, at rest and dynamic conditions.
6. Abbreviations
 SOP - Standard Operating Procedure
 HEPA-High Efficiency Particulate Air

SOP For Temperature Control Test Procedure

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SOP For Temperature Control Test Procedure

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SOP for Temperature Control Test Procedure

This procedure is applicable to – HEPA filter Utilities in Humanwell Pharmaceutical

5. Material and Equipment

7. Related Documents /Applicable document/

Related Documents./ Title

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