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TD PQ

i have need to tray dryer qualification

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0% found this document useful (0 votes)
180 views20 pages

TD PQ

i have need to tray dryer qualification

Uploaded by

asghar.ali
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Installation, Operational and

Performance Qualification Report of


Tray Dryer (TD)

Equipment Name : Tray Dryer

Equipment Model No.: XYZ

Equipment Sr. No.: XYZ

Equipment ID No.: VTD/XYZ

Equipment Area : Drying room

Equipment Manufacturer Name :

Equipment Application : For drying of wet granules and pellets

Report Date :
REPORT APPROVAL:

Prepared Checked Approved


by by by

Signature

Date

Name

Departmen Quality Head -


Maintenance Production Head – Quality Assurance
t Assurance Maintenance

Corporate Office: – XYZ Factory:-

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

Installation verification report … 4–5

Technical specification verification report … 6–8

Sub components specification verification report … 8–9

Measuring Device Calibration Verification Report… 10

Utility verification report… 10

Safety features verification report … 10 – 11

Material of construction (MOC) verification report … 11 – 12

Test /inspection certificate verification report … 12 – 13

Operational functionality verification Report… 13 – 14

Temperature verification report… 15 – 16

Performance verification report… 16 – 17


Deviation report … 18

Change control… 18

List of annexure 18

Summary and conclusion of qualification 19

Certification of qualification 19

Abbreviations:

Sr. No. Abbreviation Full Form

°C Degree centigrade

% Percentage

± Plus minus

AC Alternative current

cm2 Square centimetre

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

MIDC Maharashtra state industrial development corporation

MOC Material of construction

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

VTD Vacuum tray dryer

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.

 5.1 Installation Verification Report

Sr. Acceptance Checked by


Check point Observations
No. Criteria (Specification) Sign/Date

1. Visually there should


Visual inspection of the equipment.
0 not be any abnormality.

Area of installation
should have sufficient
2.
Check the area of installation (Dryer area cubicle). space for operation and
0
servicing of the
equipment.

Air bubble shall be at


3. Check the levelling of the machine using level
centre position of level
0 indicator.
indicator.

Major components and


4. Check the major components and their electrical their electrical cables
0 cables for housing and anchoring. shall be securely housed
and anchored.

5. All electrical ports shall


Check the electrical ports.
0 be cleaned.

6. Check the electrical circuit All electrical


0 diagram. connections shall be
found connected as per
Sr. Acceptance Checked by
Check point Observations
No. Criteria (Specification) Sign/Date

electrical circuit
drawing (reference No.
DW-CE010)

 Technical Specification Verification Report

Sr. Acceptance
Check point Observations Checked by Sign/Date
No. Criteria (Specification)

96 trays with approx 2 –


1.0 Loading capacity 3 kg material in each
trays

Approximate 2750 (L) x


2.0 Dimension
1900 x 2400 (H) mm

Heating shelf’s shall be


provided for holding and
heating the
trays.Sufficient distance
3.0 Heating shelfs
shall be provided
between two trays after
mounting the trays on
the shelfs.

Door bolts shall be


4.0 Door bolts provided to lock the
vacuum chamber door.
Sr. Acceptance
Check point Observations Checked by Sign/Date
No. Criteria (Specification)

Vacuum pump facility


shall be provided to
5.0 Vacuum pump
generate the vacuum in
the chamber.

Condenser facility shall


be provided for
6.0 Condenser condensing the vapors
drawn from vacuum
chamber.

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.

Circulation pump shall


10.0 Circulation pump be provided to circulate
the hot water through
drying equipment and
tank.
Sr. Acceptance
Check point Observations Checked by Sign/Date
No. Criteria (Specification)

Vacuum break valve


Vacuum break shall be provided in front
11.0
valve of equipment for easy
access.

Nitrogen purging valve


Nitrogen purging shall be provided in front
12.0
valve of equipment for easy
access.

View glass shall be


provided in front of
13.0 View glass
equipment to view the
indoor material.

Driving/electrical
14.0
parts

Driving and electrical


parts shall be covered
with SS304
Driving and material.There shall be
14.1
electrical parts separate cabinet for
electrical parts to avoid
pollutions from driving
parts.

15.0 Operating panel

15.1 Operating panel Operating panel shall be


installed in front of
equipment for easy
access.
Sr. Acceptance
Check point Observations Checked by Sign/Date
No. Criteria (Specification)

Emergency stop button


shall be provided on
Emergency stop
15.2 operating panel to stop
button
the equipment in
emergency.

 Sub Components Specification Verification Report

Sr. Acceptance Checked by


Check point Observations
No. Criteria (Specification) Sign/Date

1.0 Condenser Qty.: 1 No.

2.0 Receiver Qty.: 1 No.

4.0 Circulation pump Qty.: 1 Set.

5.0 Motor Qty.: 1 No.

6.0 Sensor details

Incoming hot water


6.1 Qty.: 1 No.
temperature sensor

6.2 Inlet temperature sensor Qty.: 1 No.

Product temperature
6.3 Qty.: 1 No.
sensor
Sr. Acceptance Checked by
Check point Observations
No. Criteria (Specification) Sign/Date

7.0 Electrical parts

Rupture disc/ Explosion


7.1 Qty.: 1 No.
vent

8.0 Pneumatic parts

Inlet control solenoid


8.1 Qty.: 1 Set
valve

8.2 Steam inlet control valve Qty.: 1 Set

8.3 Vacuum gauge Qty.: 1 Set

 5.3 Measuring Device Calibration Verification Report

ID. Calibration Done On Checked


Sr. Measuring Acceptance
No./ Sr. and Calibration Due Observation by
No. Device Criteria
No. Date Sign/Date

It shall be
within its
Multimeter
calibration
period.

 5.4 Utility Verification Report


Sr. Utility Checked by
Acceptance Criteria (Specification) Observations
No. parameter Sign/Date

Three phase 415 V AC ± 10% and 50


1.0 Electrical
Hz ± 5%.

2.0 Steam supply NLT 6.0 kg/cm2

 5.5 Safety Features Verification Report

Sr. Checked by
Safety features Acceptance Criteria (Specification) Observations
No. Sign/Date

Edges of construction shall be


1.0 Edges
rounded.

2.0 Electricity The equipment shall be earthed.

3.0 Driving part Driving part shall be covered.

Emergency stop Emergency stop switch shall be


4.0
button provided.

The equipment shall consist of


5.0 Sealing system
inflatable gaskets.

Rupture disc provision shall be


Vacuum relief
6.0 provided to opens at a pressure of 0.25
plate/explosion disk
bar.

7.0 Control panel Control panel shall be flameproof.


 5.6 Material of Construction (MOC) Verification Report

Sr. Acceptance Checked by


Component Observations
No. Criteria (Specification) for MOC Sign/Date

1.0 Chamber SS 316

2.0 Tray SS 316

3.0 Heating shelfs SS 316

4.0 Condenser SS 316

5.0 Receiver SS 316

Support
6.0 SS 304
columns/legs

Hot water
7.0 SS 304
distribution headers

8.0 Tank SS 304

Steam inlet control


9.0 SS 304
valve

Silicone rubber
10.0 Food grade
gaskets

 5.7 Test/Inspection Certificate Verification Report


Sr. Acceptance Checked by
Check point Observations
No. Criteria (Specification) Sign/Date

It shall be tested/inspected for its


1.0 Motor
performance.

It shall be tested/inspected for its


2.0 Vacuum pump
performance.

It shall be tested/inspected for its


3.0 Circulation pump
performance.

It shall be tested/inspected for its


4.0 Sensor
performance.

It shall be tested/inspected for its


5.0 Vacuum gauge
performance.

Control panel It shall be tested/inspected for its


6.0
flame proof performance.

It shall be tested/inspected for its


7.0 Rupture disc
performance.

Steam inlet control It shall be tested/inspected for its


8.0
valve performance.

Wall panel It shall be tested/inspected for its


9.0
insulation material performance.

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.

 5.8 Operational Functionality Verification Report

Sr. Checked by
Operation Acceptance Criteria Observations
No. Sign/Date

Turn the main switch panel (red)


1.0 Main panel shall turn ON.
ON/OFF button to ON position.

Turn the main switch panel (red) Main panel shall turn
2.0
ON/OFF button to OFF position. OFF.

Press (green) ON button of hot Hot water pump shall turn


3.0
water pump ON.

Press (red) OFF button of hot Hot water pump shall turn
4.0
water pump OFF.

Press (green) ON button of Vacuum pump shall turn


5.0
vacuum pump ON.

Press (red) OFF button of hot Vacuum pump shall turn


6.0
water pump OFF.

By pressing temp set (green) Hot water temperature


7.0 button set the hot water shall be entered
temperature at 90°C. successfully.

By pressing up (green) button Set hot water temperature


8.0 increase the set hot water shall increase
temperature. successfully.
Sr. Checked by
Operation Acceptance Criteria Observations
No. Sign/Date

By pressing down (green) button Set hot water temperature


9.0 decrease the set hot water shall decrease
temperature. successfully.

 5.9 Temperature Verification Report

Sr. Acceptance Checked by


Operation Observations
No. Criteria Sign/Date

Set the hot water system temperature at 40°C


For
and record the hot water inlet temperature and
1.0 information
product temperature from temperature controller
only
panel.

Set the hot water system temperature at 50°C


For
and record the hot water inlet temperature and
2.0 information
product temperature from temperature controller
only
panel.

Set the hot water system temperature at 60°C


For
and record the hot water inlet temperature and
3.0 information
product temperature from temperature controller
only
panel.

Set the hot water system temperature at 70°C


For
and record the hot water inlet temperature and
4.0 information
product temperature from temperature controller
only
panel.

5.0 Set the hot water system temperature at 80°C For


and record the hot water inlet temperature and information
product temperature from temperature controller
panel.
Sr. Acceptance Checked by
Operation Observations
No. Criteria Sign/Date

only

Set the hot water system temperature at 90°C


For
and record the hot water inlet temperature and
6.0 information
product temperature from temperature controller
only
panel.

 5.10 Performance Verification Report


 5.10.1 LOD Report:

Minimum capacity of VTD:

Product Name : Batch No.:

Batch Size :

Sr. LOD Result at LOD Result at Checked by


Sample Location
No. Initial End sign/date

1.0 Top Centre Tray

2.0 Middle Centre Tray

Bottom Centre
3.0
Tray

 5.10.2 LOD Report:

Maximum capacity of VTD:


Batch No.:
Product Name :

Batch Size :

Sr. LOD Result at LOD Result at Checked by


Sample Location
No. Initial End sign/date

Top Centre Tray

Middle Centre Tray

Bottom Centre
Tray

 5.10.3 Temperature mapping study report:

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 :

 Minimum temperature location:


 Highest fluctuation location:
 Maximum temperature location:

 6.0 DEVIATION REPORT:

Sr. No Deviation Justification for acceptance Impact on installation, operation and


. (s) criteria performance

 7.0 CHANGE CONTROL:

 8.0 LIST OF ANNEX:

 9.0 SUMMARY AND CONCLUSION OF QUALIFICATION:

 10.0 CERTIFICATION OF QUALIFICATION:

Qualification is satisfactory. Yes/No

Hence equipment can be used for routine use. Yes/No

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