TD PQ
TD PQ
Report Date :
REPORT APPROVAL:
Signature
Date
Name
Sr.
Title Page No
No.
Report approval 1
Table of contents 2
Abbreviations… 3
Objective …… 4
Scope ……… 4
Responsibilities … 4
Equipment description … 4
Procedure … 4
Change control… 18
List of annexure 18
Certification of qualification 19
Abbreviations:
°C Degree centigrade
% Percentage
± Plus minus
AC Alternative current
Dist. District
DQ Design qualification
H Height
Sr. No. Abbreviation Full Form
Hz Hertz
ID Identification
i.e. That is
IQ Installation qualification
kg Kilogram
L Length
No. Number
OQ Operational qualification
PQ Performance qualification
PR Production
Sr. No. Abbreviation Full Form
QA Quality assurance
Qty. Quantity
Sr. Serial
SS Stainless steel
V Voltage
W Width
1. OBJECTIVE:
1. To record the findings of installation, operational and performance qualification of
vacuum tray dryer having ID. No. VTD/XYZ.
2.0 SCOPE:
The scope of this report is limited to vacuum tray dryer having ID. No. P/PR/VTD/001.
3.0 RESPONSIBILITIES:
Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire
qualification activity.
Quality Assurance Officer/Executive: To witness the qualification study and ascertain that
the study is conducted as per the protocol.
Production Officer/Executive: To execute qualification study in co-ordination with other
departments.
Head Maintenance: To review the qualification documents.
Head Quality Assurance: To review and approve the qualification documents.
4.0 EQUIPMENT DESCRIPTION:
AS per installation qualification protocol No.: XYZ/IQ/OQ/PQ/XYZ.
5.0 PROCEDURE:
Qualification of the equipment should meet the acceptance criteria outlined in the following
steps.
Area of installation
should have sufficient
2.
Check the area of installation (Dryer area cubicle). space for operation and
0
servicing of the
equipment.
electrical circuit
drawing (reference No.
DW-CE010)
Sr. Acceptance
Check point Observations Checked by Sign/Date
No. Criteria (Specification)
Receiver shall be
provided to collect the
7.0 Receiver condensate solvent and
to draw vapour through
vacuum pump.
Digital temperature
Digital
indicator cum controller
temperature
8.0 shall be provided to
indicator cum
control the incoming hot
controller
water temperature.
Digital temperature
indicator shall be
Digital
provided to display the
9.0 temperature
inlet temperature and
indicator
product temperature of
dryer.
Driving/electrical
14.0
parts
Product temperature
6.3 Qty.: 1 No.
sensor
Sr. Acceptance Checked by
Check point Observations
No. Criteria (Specification) Sign/Date
It shall be
within its
Multimeter
calibration
period.
Sr. Checked by
Safety features Acceptance Criteria (Specification) Observations
No. Sign/Date
Support
6.0 SS 304
columns/legs
Hot water
7.0 SS 304
distribution headers
Silicone rubber
10.0 Food grade
gaskets
Guarantee/Warrantee certificate
10.0 Vacuum tray dryer
shall be provided.
Note: Whether component is tested /inspected of its performance shall be verified based on
the test/inspection certificate provided by the manufacturer.
Sr. Checked by
Operation Acceptance Criteria Observations
No. Sign/Date
Turn the main switch panel (red) Main panel shall turn
2.0
ON/OFF button to OFF position. OFF.
Press (red) OFF button of hot Hot water pump shall turn
4.0
water pump OFF.
only
Batch Size :
Bottom Centre
3.0
Tray
Batch Size :
Bottom Centre
Tray
Temperature mapping study is carried out with maximum batch size (i.e. by loading 96 trays
with approximately 2 to 3 kg material in each tray) with data recording interval of 15 min.
Batch No.:
Product Name :
Batch Size :