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Performed
validation services covering IOQ of cold storage units and ovens. The objective of this Installation
and Operational Qualification (IOQ) is to verify that the upright freezer units,
cold rooms, and ovens have been installed and operate
in accordance with manufacturer's recommendations, design specifications,
and current Good Manufacturing Practices (cGMP). Verification was performed to ensure that the equipment was
installed properly and all required utilities meet design specifications
during the Installation Qualification.
For the Operational Qualification, the upright freezer units,
cold rooms, and ovens were functionally tested to ensure temperature accuracy
and stability.
The scope of the validation was to determine the requirements of the
Operational Qualification (OQ), which encompassed the specification
of the freezers units, cold rooms, ovens, and all associated utilities.
The recorded data determines if the acceptance criteria was met. A
copy of all applicable SOPs were also included at the completion of
validation.
The operational and performance qualification (OQ/PQ) tests consisted of
Thermal Mapping, Door Challenge, Alarm Verification, and Worst Case Scenario.
All measured temperatures were printed at certain intervals using a Kaye
Digistrip while data was recorded simultaneously by Collect Program. The Kaye
Digistrip Recorder and Kaye Intelligent RTD Probe used during validation were
pre-calibrated before the test and post-calibrated upon the completion of the
test.
Thermal Profile of Low Temperature Storage Units were recorded and printed
over 24 hours using Kaye Digistrip, while data was collected to an IBM
compatible laptop using Collect Program.
A calibrated Honeywell chart recorder was attached to the freezer unit and
cold room to provide independent temperature monitoring and alarm.
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